| ACE inhibitor versus calcium-channel blocker | |||
| STOP-2 (ACEI vs CCB) (diabetic subgroup), 2000 | ACE inhibitor versus calcium antagonists | diabetic (subgroup) elderly patients aged 70-84 years | open with blind assessment Follow-up duration: 5.03y Sweden |
| ACE inhibitor versus diuretic or beta-blocker | |||
| STOP-2 (ACEI, diabetic subgroup), 2000 | ACE inhibitor versus conventional treatment (diuretic or beta-blocker) | diabetic (subgroup) elderly patients aged 70-84 years with hypertension | open with blind assessment Follow-up duration: 5.03y Sweden |
| ACE inhibitors versus placebo | |||
| HOPE (diabetic subgroup), 2000 | ramipril 10 mg once per day orally versus placebo | patients with diabetes (sub group), aged 55 years or older, who had a previous cardiovascular event or at least one other cardiovascular risk factor, no clinical proteinuria, heart failure, or low ejection fraction | double-blind Follow-up duration: 4.5 years North, South america, Europe |
| aggressive cholesterol-lowering versus moderate cholesterol-lowering | |||
| Post CABG (diabetic sub group), 1999 | aggressive cholesterol-lowering versus moderate cholesterol-lowering | patients 1-11 years after CABG | double blind |
| aggressive treatment versus standard teatment | |||
| SANDS, 2008 NCT00047424 | aggressive targets of LDL-C of 70 mg/dL or lower and SBP of 115 mm Hg or lower versus standard targets of LDL-C of 100 mg/dL or lower and SBP of 130 mm Hg or lower | adults with type 2 diabetes | open Follow-up duration: 3 years US |
| AHA 2 diet versus AHA 1 diet | |||
| Liao, 2002 | American Heart Association (AHA) step 2 diet (<30% of total calories as fat, <7% saturated fat, 55% carbohydrate, and < 200 mg cholesterol daily) plus endurance exercise for 1 h three times a week versus AHA step 1 diet (30% of total calories as fat, 10% saturated fat, 50% carbohydrate, and <300 mg cholesterol) plus stretching exercise three times a week | Japanese American subjects with impaired glucose tolerance (WHO criteria 1998) | open Follow-up duration: 22 months USA |
| albiglutide versus placebo | |||
| Seino, 2009 NCT00530309 | albiglutide 15 mg weekly, 30 mg weekly, 50 mg biweekly, and
100 mg monthly versus placebo | Japanese subjects with type 2 diabetes mellitus | single-blind Follow-up duration: 4 weeks (+5 wk) Japan |
| albiglutide biweekly versus placebo (add on MET) | |||
| Rosenstock (30 mg every two weeks), 2009 NCT00518115 | albiglutide
30mg weekly
versus placebo | patients with type 2 diabetes inadequately controlled with diet and exercise or metformin monotherapy | double blind Follow-up duration: 16 weeks US, Mexico, Chile, Dominical republic |
| albiglutide weekly versus placebo (add on MET) | |||
| Rosenstock (30 mg weekly), 2009 NCT00518115 | albiglutide
30mg weekly versus placebo | patients with type 2 diabetes inadequately controlled with diet and exercise or metformin monotherapy | double-blind Follow-up duration: 16 weeks US, Mexico, Chile, Dominical republic |
| aleglitazar versus placebo | |||
| ALECARDIO, NCT01042769 | versus | ||
| ALEPREVENT, EUDRACT201200067116 | aleglitazar 150 ìg versus placebo | patients with T2D or prediabetes with established, stable CV disease | double-blind Follow-up duration: 58 days |
| ALECARDIO, 2014 NCT01042769 | aleglitazar 150 ìg daily versus placebo | patients hospitalized for ACS (myocardial infarction or unstable angina) with type 2 diabetes | double-blind Follow-up duration: 2 years ( median) |
| alogliptin versus placebo | |||
| EXAMINE, 2013 NCT00968708 | alogliptin versus placebo | patients with type 2 diabetes and either an acute myocardial infarction or unstable angina requiring hospitalization within the previous 15 to 90 days | double-blind Follow-up duration: 1.5 years (median) |
| EXAMINE, 2011 NCT00968708 | versus | ||
| alogliptin versus placebo (add on MET) | |||
| Nauck, 2009 NCT00286442 | alogliptin 12.5 and 25 mg once daily versus placebo | patients whose HbA(1c) levels were inadequately controlled on metformin alone | double-blind Follow-up duration: 26 weeks |
| amlodipine versus atenolol | |||
| ASCOT (subgroup), 2008 | amlodipine with addition of perindopril as required versus atenolol with addition of thiazide as required | Patients with untreated hypertension or treated hypertension; diabetic subgroup with two additionnal risk factors | double-blind Follow-up duration: 5.7y |
| amlodipine versus chlorthalidone | |||
| ALLHAT (amlodipine vs chlor, diabetic subgroup), 2002 | amlodipine versus chlorthalidone | diabetic (subgroup) participants aged 55 years or older with hypertension | double-blind Follow-up duration: 4.9 y |
| amlodipine versus fosinopril | |||
| FACET, 1997 | amlodipine (long acting) 10 mg daily versus fosinopril 20 mg daily | hypertensive patients with NIDDM | open Follow-up duration: 3.5 y Italy |
| amlodipine versus placebo | |||
| IDNT (amlodipine vs PBO), 2001 | Amlodipine 10 mg daily versus placebo | hypertensive patients with nephropathy due to type 2 diabetes | double-blind Follow-up duration: 2.6 years Worldwide |
| aspart versus premix | |||
| Bretzel, 2004 | preprandial insulin aspart versus human premix (70% NPH/30% regular) insulin | ||
| aspart + basal versus continuous infusion | |||
| Raskin, 2003 | multiple daily injection bolus insulin aspart and basal NPH insulin versus continuous subcutaneous insulin infusion | ||
| aspert premix versus glargine + SU | |||
| Tamemoto, 2007 | twice-daily 70/30 aspart premix versus once-daily glargine plus sulfonylurea | insulin-naive Japanese patients with type 2 diabetes patients insufficiently controlled with sulfonylurea | open-label |
| aspirin versus no treatment | |||
| PPP (diabetics sub group), 2003 | aspirin 100mg daily versus control | men and women with diabetes and without a previous cardiovascular event aged >50 with >=1 risk factors for cardiovascular disease - sub group of diabetic patients | open Follow-up duration: 3.6 y Italy |
| JPAD, 2008 NCT00110448 | low-dose aspirin (81 or 100 mg per day) versus no aspirin | patients with type 2 diabetes without a history of atherosclerotic disease | open Follow-up duration: 4.37 y median Japan |
| aspirin versus placebo | |||
| PHS (diabetics sub group), 1989 | aspirin 325 mg every other day versus placebo | healthy men (diabetic sub group of patients enrolled if PHS) | double blind Follow-up duration: 5 y |
| ETDRS, 1992 | aspirin 650mg once daily versus placebo | patients with diabetes mellitus (Type I or II) | double blind Follow-up duration: 60 months |
| WHS (diabetics sub group), 2005 | aspirin 100mg on alternate days versus placebo | healthy women 45 years of age or older - diabetics sub groups | double blind Follow-up duration: 10.1 y US |
| POPADAD aspirin, 2008 ISRCTN53295293 | aspirin 100mg daily versus placebo | patients with diabetes mellitus and asymptomatic peripheral arterial disease | double blind Follow-up duration: nov 1997 - jul 2001 Scotland |
| DAMAD, 1989 | aspirin alone (330 mg 3 times daily) or in combination with dipyridamole (75 mg 3 times daily) versus placebo | patients with early diabetic retinopathy | double blind Follow-up duration: 3 y |
| atorvastatin versus placebo | |||
| ASCOT (diabetics sub group), 2003 | 10 mg atorvastatin versus placebo | hypertensive patients with no history of coronary heart disease (CHD) but at least three cardiovascular risk factors | |
| ASPEN, 2006 | atorvastatin 10mg daily versus placebo | patients s with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets | double blind Follow-up duration: 4y |
| ASPEN (primary prevention sub group), 2006 | atorvastatin 10mg versus placebo | subjects with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets; primary prevention subgroup | double blind Follow-up duration: 4 year 14 countries |
| CARDS, 2004 NCT00327418 | atorvastatin 10mg/d versus placebo | patients with type 2 diabetes without high concentrations of LDL-cholesterol and at least one of the following: retinopathy, albuminuria, current smoking, or hypertension. | double blind Follow-up duration: 3.9 years UK, Irelande |
| atorvastatin high dose versus atorvastatin | |||
| TNT (diabetic sub group), 2006 | atorvastatin 80 mg daily versus atorvastatin 10 mg daily | patients with stable coronary heart disease | double blind Follow-up duration: 4.9 y |
| basal-bolus versus premix | |||
| GINGER (Fritsche), 2010 | basal-bolus regimen with glargine and glulisine versus twice-daily premix | ||
| basal-bolus therapy versus biphasic insulin aspart 30 | |||
| Liebl, 2009 | analogue basal-bolus therapy (insulin detemir once daily and insulin aspart mealtimes) versus biphasic insulin aspart 30 twice daily | ||
| benazepril + amlodipine versus benazepril + hydrochlorothiazide | |||
| ACCOMPLISH (diabetic subgroup), 2010 NCT00170950 | benazepril, combined with amlodipine versus benazepril, combined with hydrochlorothiazide | patients with diabetes (subgroup) and hypertension at high risk of cardiovascular and related events | double-blind Follow-up duration: 36 months US, Norway, Denmark, Finland |
| BIAsp 30 + MET versus glargine + GLIM | |||
| Kann, 2006 | twice-daily biphasic insulin aspart 30 + MET versus once-daily insulin glargine (glarg) plus glimepiride | insulin-naïve patients | open-label |
| BIAsp 30)twice-daily + metformin versus once-daily glargine + metformin + secretagogues | |||
| Ligthelm, 2011 | biphasic insulin aspart 70/30 (BIAsp 30)twice-daily + metformin versus once-daily glargine + metformin + secretagogues | type 2 diabetic patients who were not maintaining glycemic control on basal insulin and oral antidiabetic drugs | open-label Follow-up duration: 24 weeks |
| BiAsp 70/30 versus NPH | |||
| Kilo, 2003 | once-daily biphasic insulin aspart 70/30 (10 min before dinner) versus once daily NPH insulin (at 10 pm) | ||
| BIAsp 70/30 twice daily versus detemir once daily | |||
| 4T (Holman), 2007 ISRCTN51125379 | biphasic insulin aspart (NovoMix 30) twice daily versus basal insulin detemir once daily (twice if required) | patients with a suboptimal glycated hemoglobin level (7.0 to 10.0%) who were receiving maximally tolerated doses of metformin and sulfonylurea | Follow-up duration: 1 year |
| BIAsp 70/30 twice daily versus glargine once daily | |||
| Kalra, 2010 | BIAsp 30 once-daily biphasic insulin aspart 70/30 (NovoMix 30 FlexPen) versus insulin glargine once daily | Asian subjects with type 2 diabetes inadequately controlled with oral anti-diabetic drugs | open-label Follow-up duration: 26 weeks Asia |
| INITIATE (Raskin), 2005 | BIAsp 70/30, prebreakfast and presupper versus once-daily insulin glargine | insulin-naive patients with HbA(1c) values >/=8.0% on >1,000 mg/day metformin alone or in combination with other OADs | open-label Follow-up duration: 28 weeks |
| Strojek, 2009 | biphasic insulin aspart 30 (BIAsp 30) once daily versus insulin glargine once daily | patients with type 2 diabetes inadequately controlled with oral drugs | open-label Follow-up duration: 26 weeks |
| BIAsp 70/30 twice daily versus NPH twice daily | |||
| Christiansen, 2003 | Twice daily biphasic insulin aspart (BIAsp30) versus NPH insulin twice daily | patients with type 2 diabetes not optimally controlled by oral hypoglycaemic agents, NPH insulin or a combination of both | double-blind Follow-up duration: 18 weeks |
| BID BIAsp 30 versus TID BIAsp 30 | |||
| Yang, 2009 | Thrice-daily biphasic insulin aspart 30 versus BID BIAsp 30 | Chinese patients with type 2 diabetes inadequately controlled with oral antidiabetic agents | China |
| biphasic aspert 30 versus multiple daily injections of insulin aspart | |||
| JDDM 11 (Hirao), 2008 | twice-daily injections of biphasic insulin aspart 30 versus multiple daily injections of insulin aspart | Japanese type 2 diabetic patients | |
| biphasic insulin aspart 30 versus insulin detemir | |||
| Lundby, 2009 | biphasic insulin aspart 30 versus insulin detemir before bedtime | ||
| calcium-channel blocker versus diuretic or beta-blocker | |||
| STOP-2 (CCB, diabetic subgroup), 2000 | Calcium-channel blocker versus diuretic or beta-blocker | diabetic (subgroup) elderly patients aged 70-84 years | open with blind assessment Follow-up duration: 5.03y Sweden |
| canagliflozin versus placebo | |||
| CANVAS, 2017 NCT01032629 | canagliflozin versus placebo | participants with type 2 diabetes and high cardiovascular risk | double-blind Follow-up duration: 188.2 weeks (mean) |
| candesartan versus control | |||
| SCOPE (diabetic subgroup), 2003 | candesartan versus control | sub group of diabetic patients aged 70-89 years, with systolic blood pressure 160-179 mmHg, and/or diastolic blood pressure 90-99 mmHg, and a Mini Mental State Examination (MMSE) test score >or= 24 | double-blind Follow-up duration: 3.7 years 15 countries |
| captopril versus atenolol | |||
| UKPDS 39, 1998 | captopril 25 mg/d aiming at a BP <150/85 versus atenolol 50mg/d aiming at a BP <150/85 | hypertensive patients with type 2 diabetes | open Follow-up duration: ND UK |
| captopril versus diuretic and/or beta-blockers | |||
| CAPP (diabetic subgroup), 1999 | Captopril initial dose of 50 mg daily given in one or two doses versus thiazide diuretic or beta-blocker | Patients aged 25-66 years with a measured diastolic blood pressure of 100 mm Hg or more on two occasions; subgroup of diabetic patients | open with blinded assessment Follow-up duration: 6.1 year Sweden, Finland |
| captopril or atenolol versus control | |||
| UKPDS 38, 1998 | tight control of blood pressure aiming at a BP <150/85 (with the use of captopril or atenolol as main treatment, other treatment were added if the control criteria were not met) versus less tight control aiming at a blood pressure of <180/105 (avoiding treatment with ACE inhibitors or beta-blockers) | hypertensive patients with type 2 diabetes | open Follow-up duration: 8.4y (median) UK |
| carvedilol versus metoprolol | |||
| GEMINI, 2004 | 6.25- to 25-mg dose of carvedilol twice daily versus 50- to 200-mg dose of metoprolol tartrate twice daily | patients with hypertension and type 2 diabetes mellitus receiving renin-angiotensin system blockade | double-blind Follow-up duration: 5 months |
| chlorthalidone versus placebo | |||
| SHEP (diabetic subgroup), 1996 | low dose of chlorthalidone (12.5-25.0 mg/d) with a step-up to atenolol (25.0-50.0 mg/d) or reserpine (0.05-0.10 mg/d) if needed versus placebo | men and women aged 60 years and older , non-insulin-treated diabetic (sub group) patients with isolated systolic hypertension (systolic BP >= 160 mm Hg; diastolic BP, <90 mm Hg) | double-blind Follow-up duration: 5 year |
| combination versus placebo | |||
| POPADAD (antioxydant), 2008 ISRCTN53295293 | antioxidant capsule containing (alpha-tocopherol 200 mg, ascorbic acid 100 mg, pyridoxine hydrochloride 25 mg, zinc sulphate 10 mg, nicotinamide 10 mg, lecithin 9.4 mg, and sodium selenite 0.8 mg) versus placebo | patients with diabetes mellitus and asymptomatic peripheral arterial disease | double blind Scotland |
| dapagliflozin versus dlipizide add on metformin | |||
| Nauck, 2011 NCT00660907 | Dapagliflozin in Combination With Metformin versus Sulphonylurea in Combination With Metformin | Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone | |
| dapagliflozin versus placebo | |||
| DECLARE TIMI 58, 2018 NCT01730534 | Dapagliflozin versus | adults with T2D at risk of CV events, including patients with multiple CV risk factors or established CV disease | double-blind Follow-up duration: approx 4 years (median) |
| Kohan, NCT00972244 | Dapagliflozin as Monotherapy versus placebo | Japanese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control | |
| Kaku, 2014 NCT01294423 | versus | Follow-up duration: 24 w Japan | |
| Ferrannini (MB102013), 2010 NCT00528372 | a morning dose of 5 or 10 mg/day dapagliflozin versus placebo | treatment-naive patients with type 2 diabetes | double-blind Follow-up duration: 24 weeks |
| Komoroski (MB102007), 2009 NCT00162305 | daily oral doses of 5-, 25-, or 100-mg doses of dapagliflozin versus placebo | patients with type 2 diabetes mellitus | Follow-up duration: 14 days |
| List (MB102008), 2009 NCT00263276 | one of five dapagliflozin doses versus placebo | type 2 diabetic patients | Follow-up duration: 12 weeks |
| Kohan, 0 NCT00663260 | Dapagliflozin versus placebo | Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Contro | |
| KOhan, 0 NCT00736879 | Dapagliflozin monotherapy versus placebo | ||
| dapagliflozin versus placebo (add on insulin) | |||
| Wilding, 2012 NCT00673231 | Dapagliflozin versus placebo on top of insulin | Type 2 Diabetes With Inadequate Glycaemic Control on Insulin | |
| Wilding (MB102009), 2009 NCT00357370 | 10 mg dapagliflozin, or 20 mg dapagliflozin, plus OAD(s) and 50% of their daily insulin dose versus placebo | patients with type 2 diabetes that is poorly controlled with high insulin doses plus oral antidiabetic agents | double-blind Follow-up duration: 12 weeks US, Canada |
| dapagliflozin versus placebo (add on MET + SAXA) | |||
| Mathieu, 2015 NCT01646320 | versus | Follow-up duration: 24 w USA | |
| dapagliflozin versus placebo (add on MET) | |||
| Bailey (MB102014), 2010 NCT00528879 | dapagliflozin (2¡¤5 mg, n=137; 5 mg, n=137; or 10 mg, n=135) versus placebo | adults with type 2 diabetes who were receiving daily metformin (¡Ý1500 mg per day) and had inadequate glycaemic control | double-blind Follow-up duration: 24 weeks |
| Bolinder, 2012 NCT00855166 | dapagliflozin versus placebo or Sitagliptin (on top MET) | ||
| Schumm-Draeger , 2015 NCT01217892 | Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD versus placebo | Patients With Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy | |
| dapagliflozin versus placebo (add on MET+SU) | |||
| Matthaei, 2015 NCT01392677 | versus | Canada | |
| dapagliflozin versus placebo (add on TZD) | |||
| Rosenstock, 2012 NCT00683878 | Dapagliflozin in Combination With Thiazolidinedione versus Thiazolidinedione | Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone | |
| dapagliflozin versus placebo (on top standard treatment) | |||
| Leiter, 2016 NCT01042977 | Dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment versus placebo | Patients With T2DM and Cardiovascular Disease, Who Exhibit Inadequate Glycaemic Control on Usual Care | |
| MB102035, NCT00976495 | Dapagliflozin
Tablets, Oral, 10 mg, once daily, 12 weeks versus placebo | ||
| Cefalu, 2015 NCT01031680 | Dapagliflozin
10 mg tablet, oral, once daily, 24- week versus placebo | ||
| MB102073, NCT01137474 | Dapagliflozin
Tablets, Oral, 10 mg, once daily, up to 12 weeks versus placebo | patients with type 2 diabetes with uncontrolled hypertension who are on an Angiotensin-converting enzyme (ACE) inhibitor or an Angiotensin Receptor Blocker (ARB). | |
| Weber, NCT01195662 | Dapagliflozin
Tablets, Oral, 10 mg, once daily, Up to 12 weeks versus placebo | Subjects With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication | |
| dapagliflozin versus placebo add on DPP-4 | |||
| MB102061, NCT00984867 | Dapagliflozin
10 mg tablet, oral, once daily, 48 weeks versus placebo | Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin | |
| dapagliflozin versus Saxagliptin (add on MET) | |||
| Rosenstock, 2015 NCT01606007 | versus | Follow-up duration: 24 w USA | |
| dapagliflozin + Glimepiride versus glimepiride | |||
| Strojek, 2011 NCT00680745 | Dapagliflozin in Comb.With Glimepiride versus glimepiride alone | Type2 Diab.Who Have Inadeq. Glycaemic Control on Glimepiride Therapy Alone | |
| dapagliflozin + merformin versus dapagliflozin | |||
| Kohan, 0 NCT00643851 | Dapagliflozin in Combination With Metformin versus Dapagliflozin Monotherapy | Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control | |
| dapagliflozin + merformin versus metformin or dapa | |||
| MB102034, 2016 NCT00859898 | Dapagliflozin 10 mg in Combination With Metformin versus Dapagliflozin 10 mg Monotherapy or Metformin Monotherapy | Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control | |
| detemir versus NPH insulin (add on aspart) | |||
| Haak , | insulin detemir either once or twice daily according to their pretrial insulin treatment versus NPH insulin | patients with type 2 diabetes | open Follow-up duration: 26 weeks |
| diltiazem versus diuretic and/or beta-blocker | |||
| NORDIL (diabetic subgroup), 2000 | Diltiazem 180–360 mg diltiazem daily at step one versus thiazide diuretic or a beta-blocker at step one | diabetic patients (subgroup), aged 50-74 years who had diastolic blood pressure of 100 mm Hg or more | open Follow-up duration: 4.5 y Norway, Sweden |
| empagliflozin versus Glimepiride + MET | |||
| Ridderstrale, 2014 NCT01167881 | BI 10773 dose plus metformin versus Glimepiride 1-4 mg plus metformin | Follow-up duration: 104 w USA | |
| empagliflozin versus linagliptin (add-on MET) | |||
| DeFronzo, 2015 NCT01422876 | versus add-on to metformin for 52 weeks | subjects with type 2 diabetes inadequately controlled on metformin | |
| empagliflozin versus linagliptin (monotherapy) | |||
| Lewin, 2015 NCT01422876 | empagliflozin 25 mg/linagliptin 5 mg (n = 137), empagliflozin 10 mg/linagliptin 5 mg (n = 136), empagliflozin 25 mg (n = 135), empagliflozin 10 mg (n = 134) versus linagliptin 5 mg (n = 135) for 52 weeks | ||
| empagliflozin versus placebo | |||
| EMPA-REG OUTCOME, 0 NCT01131676 | versus | ||
| Ferrannini, 2013 NCT00789035 | empagliflozin 5, 10 or 25 mg once daily versus placebo | ||
| EMPA-REG MONO (Roden) vs placebo, 2013 NCT01177813 | versus | ||
| Kadowaki, 2015 NCT01193218 | empagliflozin (5, 10, 25, or 50 mg) versus placebo | Japanese patients with type 2 diabetes | |
| EMPA-REG OUTCOME, 2015 NCT01131676 | 10 mg or 25 mg of empagliflozin once daily versus placebo | patients with type 2 diabetes at high cardiovascular risk | double-blind Follow-up duration: 3.1 years (median) 42 countries |
| Barnett, 2014 NCT01164501 | / BI 10773 low dose (BI 10773 tablets once daily)
2/ BI 10773 high dose (BI 10773 tablets once daily)
versus Placebo | Patients With Mild or Moderate Renal Impairment | |
| empagliflozin versus placebo (add on MET+/-PIO) | |||
| EMPA-REG PIO (Kovacs), 2013 NCT01210001 | once daily empagliflozin 10 mg (n = 165), empagliflozin 25 mg versus add-on to pioglitazone ± metformin | ||
| empagliflozin versus placebo (add-on INS) | |||
| Rosenstock DOUBLON ???, 2013 | versus | ||
| empagliflozin versus placebo (add-on INS+/-MET) | |||
| Rosenstock (1245.49), 2014 NCT01306214 | once-daily empagliflozin 10 mg (n = 186), empagliflozin 25 mg (n = 189), versus placebo | Patients inadequately controlled on MDI insulin ± metformin | Follow-up duration: 18 weeks USA |
| empagliflozin versus placebo (add-on MET) | |||
| Rosenstock, 2013 NCT00749190 | versus ??? | ||
| Ross, 2015 e2012-000905-53 | empagliflozin 12.5 mg twice daily (n = 219), 25 mg once daily (n = 218), 5 mg twice daily (n = 219) or 10 mg once daily (n = 220), versus placebo | patients with type 2 diabetes inadequately controlled on metformin | |
| EMPA-REG MET (Haring), 2014 NCT01159600 | empagliflozin 10 mg (n = 217), empagliflozin 25 mg (n = 213), versus placebo | Patients with HbA1c levels of ¡Ý7% to ¡Ü 10% (¡Ý53 to ¡Ü86 mmol/mol) while receiving metformin (¡Ý1,500 mg/day) | |
| empagliflozin versus placebo (add-on standard treatment) | |||
| Araki, 2015 NCT01368081 | BI 10773 low dose (BI 10773 low dose tablet once daily)
2/ BI 10773 high dose (BI 10773 high dose tablet once daily)
versus Metformin (Metformin tablets 500-2250 mg a day (twice or three times per day)) | Japanese patients with type 2 diabetes mellitus | Follow-up duration: 52 w Japan |
| enalapril versus placebo | |||
| SCAT (diabetic subgroup), 2000 | enalapril 2.5mg twice daily versus placebo | normocholesterolemic patients | double-blind Follow-up duration: Jun 1991 - Jul 1995 Canada |
| SOLVD (subgroup), 1996 | enalapril versus placebo | patients with chronic heart failure | double-blind Follow-up duration: 3.5y |
| error versus placebo | |||
| Pan, 2003 | acarbose 50 mg three times daily versus placebo | patients with impaired glucose tolerance (American Diabetes Association 1997 criteria) | double blind Follow-up duration: 16 weeks China |
| STOP-NIDDM (Chiasson), 2002 | acarbose 100mg three times daily versus placebo | patients with impaired glucose tolerance (WHO 1985 criteria) | double blind Follow-up duration: 3.3 years Canada, Germany, Austria, Nordic countries, Spain, Israel |
| error versus placebo (add on to met) | |||
| Halimi, 2000 | acarbose titrated up to 100 mg three times daily versus placebo | patients with Type 2 diabetes and inadequately controlled with metformin monotherapy | double-blind Follow-up duration: 26 weeks |
| Rosenstock, 1998 | acarbose forced titration from 25-50 mg t.i.d. and a titration of 50-100 mg tid that was based on glucose control versus placebo | patients with type 2 diabetes inadequately controlled with diet and metformin (2,000 or 2,500 mg/day in divided doses | double-blind Follow-up duration: 24 weeks |
| exenatide versus glargine | |||
| NCT00360334, NCT00360334 | versus | ||
| exenatide versus placebo | |||
| EXSCEL, 2017 NCT01144338 | subcutaneous injections of extended-release exenatide at a dose of 2 mg once weakly versus placebo | patients with type 2 diabetes, with or without previous cardiovascular disease | double-blind Follow-up duration: 3.2 years median |
| Liutkus, 2010 | exenatide twice-daily versus placebo | subjects suboptimally controlled with TZDs with or without metformin | |
| exenatide 10µg twice daily versus liraglutide 1.8mg | |||
| LEAD 6 (Buse) exe vs lira, 2009 | versus | ||
| exenatide 10µg/d versus placebo | |||
| H8O-MC-GWBJ, 9698, 10µg/d, 2008 | exenatide twice daily 5 et 10 µg for 24 weeks
versus placebo | Drug-Naive Patients with Type 2 Diabetes and inadequate glycemic control through diet and exercise | double-blind Follow-up duration: 24 weeks 4 countries |
| exenatide 10µg/d versus placebo (add on MET) | |||
| DeFronzo 10µg/d, 2005 NCT00039013 | Exenatide 10–20 µg daily versus Placebo on-top of Metformin | patients with type 2 diabetes failing to achieve glycemic control with maximally effective metformin doses | double blind Follow-up duration: 30 weeks USA |
| exenatide 10µg/d versus placebo (add on SU) | |||
| Buse 10µg/d, 2004 NCT00039026 | Exenatide 5µg twice daily versus Placebo on-top of SU | patients with type 2 diabetes failing maximally effective doses of a sulfonylurea as monotherapy | double blind (not adequate) Follow-up duration: 30 weeks US |
| exenatide 10µg/d versus placebo (add on SU+/-MET/TZD) | |||
| Kadowaki (trial 8683), 2009 | Exenatide 10µg daily for 12 weeks versus Placebo on-top of sulphonylureas +/-metformin/thiazolidinediones | Japanese patients with type 2 diabetes suboptimally controlled despite therapeutic dose of sulfonylurea, SU+biguanide or SU+thiazolidinedione | open Follow-up duration: 12 weeks Japan |
| exenatide 10µg/d versus placebo (add on SU+MET) | |||
| Kendall 10µg/d, 2005 NCT00035984 | Exenatide 5 µg bid
versus Placebo on-top of sulphonylureas+metformin | patients with type 2 diabetes unable to achieve glycemic control with metformin-sulfonylurea combination therapy | double blind Follow-up duration: 30 weeks USA |
| exenatide 10µg/d versus placebo add on MET+/-TZD | |||
| Gill, 2010 | exenatide (5 microg for 4 weeks followed by 10 microg) for 12 weeks versus placebo | subjects with type 2 diabetes mellitus on metformin and/or a thiazolidinedione | double-blind Follow-up duration: 12 weeks |
| exenatide 20µg versus glibenclamide | |||
| Derosa, 2010 | exenatide 10 microg twice a day versus glibenclamide 5 mg three times a day | patients with uncontrolled type 2 diabetes mellitus receiving therapy with metformin | |
| exenatide 20µg/d versus BIAsp 30 daily | |||
| Bergenstal (once daily), 2009 | exenatide(5 microg BID for 4 weeks and 10 microg BID thereafter) versus biphasic insulin aspart 70/30 (BIAsp 30) 30 QD (12 U before supper) | subjects with type 2 diabetes mellitus insulin naive, not achieving glycemic targets with metformin and sulfonylurea | open Follow-up duration: 24 weeks |
| exenatide 20µg/d versus BIAsp 30 twice daily | |||
| Bergenstal (twice daily), 2009 | exenatide (5 microg BID for 4 weeks and 10 microg BID thereafter) versus biphasic insulin aspart 70/30 (BIAsp 30) 30 BID (12 U divided equally between pre-breakfast and pre-supper) | subjects with type 2 diabetes mellitus insulin naive, not achieving glycemic targets with metformin and sulfonylurea | open |
| exenatide 20µg/d versus insulin (add on SU+MET) | |||
| Heine, 2005 | Exenatide 20 µg daily versus Insulin on-top of sulphonylureas+metformin | open Follow-up duration: 26 weeks | |
| exenatide 20µg/d versus insulin (add on SU/MET) | |||
| Barnett, 2007 NCT00099619 | Exenatide 20 µg daily versus Insulin | patients with type 2 diabetes | open Follow-up duration: 16 weeks Australia, Greece,Hungary, Italy, Mexico, and Poland |
| Davis, 2007 NCT00099333 | Exenatide 20 µg daily versus Insulin on-top of sulphonylureas/metformin | patients with type 2 diabetes using insulin in combination with oral antidiabetes agents | open Follow-up duration: 16 weeks USA |
| exenatide 20µg/d versus insulin BIAsp twice daily add on SU+MET | |||
| Nauck, 2007 NCT00082407 | Exenatide 20 µg daily versus Insulin on-top of sulphonylureas+metformin | patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin | open Follow-up duration: 52 weeks 13 countries |
| exenatide 20µg/d versus insulin glargine (add on MET) | |||
| Bunck, 2009 NCT00097500 | exenatide 10µg bid versus insulin glargine | metformin-treated patients with type 2 diabetes | Follow-up duration: 52 weeks |
| exenatide 20µg/d versus placebo | |||
| Apovian, 2010 | 10 microg exenatide twice daily injection + lifestyle modification program versus placebo + lifestyle modification program | overweight or obese participants with type 2 diabetes treated with metformin and/or sulfonylurea | double-blind Follow-up duration: 24 weeks |
| H8O-MC-GWBJ, 9698, 20µg/d, 2008 | exenatide twice daily 10 µg for 24 weeks versus placebo | Drug-Naive Patients with Type 2 Diabetes and inadequate glycemic control through diet and exercise | double-blind Follow-up duration: 24 weeks 4 countries |
| exenatide 20µg/d versus placebo (add on insulin) | |||
| Buse, 2011 NCT00765817 | twice-daily 10 µg exenatide injections versus placebo (on top insulin glargine) | Adults with type 2 diabetes and an HbA1c level of 7.1% to 10.5% who were receiving insulin glargine alone or in combination with metformin or pioglitazone (or both agents) | double-blind Follow-up duration: 30 weeks Greece, Israel, Mexico, United Kingdom, USA |
| exenatide 20µg/d versus placebo (add on MET) | |||
| DeFronzo 20µg/d, 2005 NCT00039013 | Exenatide 10–20 µg daily versus Placebo on-top of Metformin | patients with type 2 diabetes failing to achieve glycemic control with maximally effective metformin doses | double blind Follow-up duration: 30 weeks USA |
| exenatide 20µg/d versus placebo (add on MET+/-SU) | |||
| Gao, 2009 NCT00324363 | exenatide 5 mg then 10 mg twice-daily for 4 and 12 weeks versus placebo | Asian desccent with type 2 diabetes and inadequate glycemic control taking metformin alone or Met and sulfonylureas | double-blind Follow-up duration: 16 weeks 4 countries |
| exenatide 20µg/d versus placebo (add on SU) | |||
| Buse 20µg/d, 2004 | Exenatide 10µg twice daily
versus Placebo on-top of SU | patients with type 2 diabetes failing maximally effective doses of a sulfonylurea as monotherapy | double blind (not adequate) Follow-up duration: 30 weeks US |
| exenatide 20µg/d versus placebo (add on SU+MET) | |||
| Kendall 20µg/d, 2005 NCT00035984 | Exenatide 10 µg bid versus Placebo on-top of sulphonylureas+metformin | patients with type 2 diabetes unable to achieve glycemic control with metformin-sulfonylurea combination therapy | double blind Follow-up duration: 30 weeks USA |
| exenatide 20µg/d versus placebo (add on TZD+/-MET) | |||
| Zinman 20µg/j, 2007 NCT00099320 | Exenatide 20 µg daily
versus Placebo on-top of thiazolidinediones+/-metformin | patients with type 2 diabetes that was suboptimally controlled with TZD treatment (with or without metformin) | double blind Follow-up duration: 16 weeks Canada, Spain, and the United States |
| Zinman 20µg/j A MODIFIER, 2007 | exenatide Subcutaneous abdominal injections of 10 microg twice daily versus placebo | patients with type 2 diabetes that was suboptimally controlled with TZD treatment (with or without metformin) | double-blind Follow-up duration: 16 weeks Canada, Spain, and the United States |
| exenatide 20µg/d versus rosiglitazone add on MET | |||
| DeFronzo (EXE vs ROSI), 2010 | EXE 10 microg b.i.d. versus ROSI 4 mg b.i.d. | subjects with type 2 diabetes on metformin | open Follow-up duration: 20 weeks |
| exenatide 20µg/d versus sitagliptin (add on MET) | |||
| DeFronzo, 2008 NCT00477581 | exenatide subcutaneous injection versus sitagliptin (100 mg QAM) for 2 weeks | metformin-treated T2D patients | double-blind Follow-up duration: 2 weeks USA |
| exenatide 20µg/d versus weekly exenatide | |||
| Drucker, 2008 NCT00308139 | 10 mug exenatide administered twice a day versus long-acting release formulation of exenatide 2 mg administered once weekly | patients with type 2 diabetes naive to drug therapy, or on one or more oral antidiabetic agents | open Follow-up duration: 30 weeks |
| exenatide before lunch and dinner versus exenatide before breakfast and dinner | |||
| Exenatide Trial 10749, | exenatide (10 ìg twice daily)
administered subcutaneously before lunch and dinner versus exenatide (10 ìg twice daily) administered subcutaneously before breakfast and dinner | patients with type 2 Diabetes using oral antidiabetic therapy | open 2 countries |
| exenatide once monthly versus weekly exenatide | |||
| phase 2 exenatide once monthly, | exenatide once monthly at a low, medium or high dose, each administered once every four weeks, for a total of 20 weeks versus exenatide 2mg once weekly | adults with type 2 diabetes who were not achieving adequate glucose control using diet and exercise alone or with a stable regimen of metformin, pioglitazone, or both | open Follow-up duration: 20 weeks |
| exenatide other doses versus glargine | |||
| HEELA (Davies), 2009 | exenatide 5¨C10 ¦Ìg
bid versus insulin glargine o.d. (titrated to target fasting plasma glucose ¡Ü5.6 mmol/l) | Patients (BMI>27 kg/m2) with elevated cardiovascular risk and type 2 diabetes inadequately controlled on two or three oral antidiabetes drugs | |
| exenatide other doses versus insulin glargine (add on MET/SU) | |||
| Trial 8078, | exenatide versus Insulin Glargine | Patients with Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin Is the Next Appropriate Therapy | |
| exenatide other doses versus placebo | |||
| Moretto (DOUBLONS avec druker), 2008 NCT00381342 | Exenatide 10–20 µg daily versus Placebo | double blind Follow-up duration: 24 weeks United States, Puerto Rico, Romania, Russia, India | |
| NCT00085969, NCT00085969 | exenatide for 28 days versus placebo | subjects with type 2 diabetes mellitus | double-blind Follow-up duration: 28 days USA |
| Poon, 2005 NCT00044694 | exenatide at 2.5, 5.0, 7.5, or 10.0 microg administered b.i.d. for 28 days versus placebo | patients with type 2 diabetes | double-blind Follow-up duration: 28 days |
| exenatide other doses versus placebo (add on MER+/-SU) | |||
| Fineman, 2003 | exenatide 3 regimen (0.08 micro g/kg) for 28 days versus placebo | patients with tyep 2 diabetes treated with diet and a sulfonylurea and/or metformin | double-blind Follow-up duration: 28 days USA |
| exenatide weekly versus insulin glargine | |||
| DURATION-3 (Diamant), 2010 NCT00641056 | exenatide (2 mg, once-a-week injection) versus insulin glargine once-daily injection | adults with type 2 diabetes who had suboptimum glycaemic control despite use of maximum tolerated doses of blood-glucose-lowering drugs for 3 months or longer | open (blind analysis) Follow-up duration: 26 weeks USA, Puerto Rico, Europe, Russia, Australia, Korea, Taiwan, Mexico |
| exenatide weekly versus pioglitazone | |||
| DURATION-2 (Bergenstal) (vs pioglitazone), 2010 NCT00637273 | 2 mg injected exenatide once weekly plus oral placebo once daily versus 45 mg oral pioglitazone once daily plus injected placebo once weekly | double blind Follow-up duration: 26 weeks USA, India, and Mexico | |
| exenatide weekly versus placebo (add on MET) | |||
| Kim, 2007 NCT00103935 | exenatide LAR 0.8 or 2 µg daily versus Placebo on-top of metformin | subjects with type 2 diabetes suboptimally controlled with metformin and/or diet and exercise | double blind Follow-up duration: 15 weeks NA |
| exenatide weekly versus sitagliptin | |||
| DURATION-2 (Bergenstal) (vs sitagliptin), 2010 NCT00637273 | 2 mg injected exenatide once weekly plus oral placebo once daily
versus 100 mg oral sitagliptin once daily plus injected placebo once weekly | patients treated with metformin | double blind Follow-up duration: 26 weeks USA, India, and Mexico |
| fenofibrate versus placebo | |||
| FIELD, 2005 ISRCTN64783481 | fenofibrate 200 mg daily versus placebo | aged 50-75 years, with type 2 diabetes mellitus, and not taking statin therapy at study entry | Follow-up duration: 5y |
| fenofibrate versus placebo (on top simvastatine) | |||
| ACCORD lipid, 2010 NCT00000620 | fenofibrate on top simvastatin versus placebo (on top simvastatine) | high-risk patients with type 2 diabetes | double-blind Follow-up duration: 4.7y United States and Canada |
| fluvastatin versus placebo | |||
| LIPS (diabetic sub group), 2002 | fluvastatin versus placebo | patients (aged 18-80 years) with stable or unstable angina or silent ischemia following successful completion of their first PCI who had baseline total cholesterol levels between 135 and 270 mg/dL | double blind Follow-up duration: 3.9y |
| ALERT (diabetic sub group), 2003 | fluvastatin versus placebo | renal transplant recipients with total cholesterol 4·0–9·0 mmol/L | double blind |
| gemfibrozil versus placebo | |||
| HHS (diabetic sub group), 1987 | gemfibrozil 600mg twice daily versus placebo | asymptomatic middle-aged men (40 to 55 years of age) with primary dyslipidemia (non-HDL cholesterol greater than or equal to 200 mg per deciliter | double blind |
| VA-HIT (diabetic sub group), 1999 | gemfibrozil 1200 mg per day versus placebo | men with coronary heart disease, an HDL cholesterol level of 40 mg per deciliter (1.0 mmol per liter) or less, and an LDL cholesterol level of 140 mg per deciliter (3.6 mmol per liter) or less. | double blind Follow-up duration: 5.1 y |
| glargine versus NPH | |||
| Riddle POC 4002 Glargine, 2003 | bedtime glargine versus NPH once daily | overweight men and women with inadequate glycemic control (HbA(1c) >7.5%) on one or two oral agents | open-label |
| HOE 901/3002, 2000 | bedtime insulin glargine versus bedtime NPH insulin | insulin-naive type 2 diabetic patients with poor glycemic control on oral antidiabetic agents | |
| glargine versus NPH + SU | |||
| Riddle , | bedtime glargine versus NPH | overweight men and women with inadequate glycemic control (HbA(1c) >7.5%) on one or two oral agents | open Follow-up duration: 24 weeks |
| glibenclamide versus c (add on MET) | |||
| Hermann, 1991 | metformin + glibenclamide versus metformin | patients with non-insulin-dependent diabetes mellitus | Follow-up duration: 6 months |
| glibenclamide versus control (add on MET) | |||
| Marre (ass), 2002 | metformin-glibenclamide 500 mg/2.5 mg or metformin-glibenclamide 500 mg/5 mg, titrated with the intention to achieve fasting plasma glucose (FPG) < or = 7 mmol/l versus metformin 500 mg, | patients with Type 2 diabetes mellitus inadequately controlled by metformin monotherapy | double-blind Follow-up duration: 16 weeks |
| Tosi, 2003 | metformin 400 to 2,400 mg/d + glibenclamide 2.5 to 15 mg/d versus metformin (500 to 3,000 mg/d), | double-blind Follow-up duration: 6 months | |
| glibenclamide versus rosiglitazone (add on MET) | |||
| Garber, 2006 | metformin-glibenclamide 500/2.5 mg tablets (initial daily dose 1000/5 mg) versus metformin 500 mg plus rosiglitazone 4 mg (initial daily dose 1000-2000 mg + 4 mg, depending on previous treatment) | patients with type 2 diabetes inadequately controlled on metformin monotherapy | double-blind Follow-up duration: 24 weeks |
| gliclazide versus nateglinide (add on MET) | |||
| Ristic, 2006 | gliclazide plus metformin versus nateglinide plus metformin | double-blind Follow-up duration: 52 weeks | |
| gliclazide versus pioglitazone (add on MET) | |||
| Matthews, 2005 | gliclazide 80 mg o.d. (titrated up to 320 mg versus pioglitazone 15 mg o.d. (titrated up to 45 mg | Patients with poorly controlled type 2 diabetes | double-blind Follow-up duration: 52 weeks |
| gliclazide versus rosiglitazone (add on MET) | |||
| Khanolkar, 2008 | metformin and gliclazide versus metformin and rosiglitazone | Follow-up duration: 24 weeks | |
| glimepiride versus glibenclamide | |||
| Draeger, 1996 | glimepiride 1 mg daily versus 2.5 mg glibenclamide | type 2 diabetic patients stabilised on glibenclamide | double-blind |
| Protocol 311, | glimepiride 1-8mg od versus glibenclamide 1.75-14 mg/day (od or bid) | ||
| glimepiride versus gliclazide | |||
| Charpentier (301F), | glimepiride 1-4mg od versus gliclazide 80-320 mg/day (od or bid) | ||
| glimepiride versus gliclazide or glibenclamide | |||
| Inukai, 2005 | glimepiride versus gliclazide or glibenclamide | Japanese type 2 diabetic patients (HbA1C > or = 7.0%), maintained on a conventional SU | open Follow-up duration: 6 months Japan |
| glimepiride versus glipizide | |||
| Clark (301), 1997 | glimepiride 1-16 mg/day (od or bid) versus glipizide 2.5-40 mg/day (od or bid) | ||
| glimepiride versus glyburide | |||
| Dills, 1996 | glimepiride 1-16mg od versus non-micronized glyburide 1.25-20mg od | patients with non-insulin dependent diabetes | double-blind |
| glimepiride versus placebo | |||
| Kaneko, 1993 | glimepiride 0.25mg od, 0.5mg od versus placebo | ||
| Luis Bautista, 2003 | glimepiride with titration to 2 mg and 4 mg for FPG levels >120 mg/dL versus placebo | Mexican American Patients with type 2 diabetes mellitus | double-blind Follow-up duration: 14 weeks Mexique |
| Rosenstock, 1996 | glimepiride 8 mg q.d., 4 mg b.i.d., 16 mg q.d., or 8 mg b.i.d versus placebo | previously treated NIDDM patients | double-blind Follow-up duration: 14 weeks |
| Schade, 1998 | glimepiride at individually determined optimal dose (1-8 mg of glimepiride) for 10+12 weeks versus placebo | patients with type 2 diabetes mellitus for whom diet therapy is unsuccessful | double-blind |
| Study 201 (Goldberg), 1996 | glimepiride, 1, 4, or 8 mg once daily versus placebo | patients with NIDDM | double-blind Follow-up duration: 14 weeks |
| Study 202, | glimepiride 1-8mg od versus placebo | ||
| glimepiride versus placebo (add on insulin) | |||
| Riddle, 1994 | Glimepiride (16 mg/day) plus insulin versus insulin plus placebo | obese patients with type 2 diabetes insufficiently controlled by full dosages of sulphonylureas (glimepiride titrated up to 8mg twice daily and with laboratory-monitored FPG of 10 to 16 mmol/L (180 to 300 mg/dl)) | |
| glimepiride versus placebo (add on MET) | |||
| Charpentier, 2001 | metformin and glimepiride versus metformin | Type 2 diabetic patients aged 35-70 years inadequately controlled by metformin monotherapy 2550 mg daily | double-blind France |
| LEAD-2 (Nauck) Sulf vs pbo, 2009 NCT00318461 | glimepiride (4 mg once daily). versus placebo | subjects previously treated with oral antidiabetes (OAD) therapy | double-blind Follow-up duration: 26 weeks |
| glimepiride monotherapy versus metformin | |||
| Charpentier, 2001 | glimepiride monotherapy versus metformin monotherapy | Type 2 diabetic patients aged 35-70 years inadequately controlled by metformin monotherapy 2550 mg daily for at least 4 weeks | double-blind Follow-up duration: 20 weeks |
| glimepiride od versus glimepiride bid | |||
| Sonnenberg, 1997 | glimepirid e6mg od versus glimepiride 3mg bid | ||
| glipizide versus control (add on MET) | |||
| Goldstein, | glipizide/metformin 5/500 mg tablets versus metformin 500-mg | patients with type 2 DM that is uncontrolled by at least half the maximum labeled daily dose of a sulfonylurea | open |
| glipizide versus glyburide | |||
| Rosenstock, 1993 | glipizide, 2.5 or 5 mg/day versus glyburide, 1.25 or 2.5 mg/day | elderly patients with NIDDM that was controlled for at least 3 months with oral sulfonylurea therapy | open Follow-up duration: 4 months |
| Birkeland, 1994 | glipizide versus glyburide | NIDDM patients | |
| Birkeland, 1994 | glipizide versus glyburide | NIDDM patients | double-blind Follow-up duration: 15 months |
| glipizide versus placebo | |||
| Simonson, 1997 | once-daily doses of 5, 20, 40, or 60 mg glipizide GITS versus placebo | NIDDM patients | double-blind Follow-up duration: 4+8 weeks |
| Testa, 1998 | 5 to 20 mg of glipizide gastrointestinal therapeutic system (GITS) versus placebo | patients with type 2 diabetes mellitus | Follow-up duration: 12 weeks USA |
| Eriksson, 2006 | glipizide 2.5 mg daily versus placebo | first-degree relatives of patients with type 2 diabetes fulfilling WHO criteria for IGT (WHO criteria in 2006) | double blind Follow-up duration: 18 months Finland |
| glipizide versus sitagliptin (add on MET) | |||
| Nauck, 2007 | glipizide versus sitagliptin | Follow-up duration: 52 weeks | |
| glipizide GITS versus placebo (add on MET) | |||
| Feinglos, 2005 | 2.5 mg glipizide GITS versus placebo | type 2 diabetes inadequately controlled (A1c 7-8.5%) on metformin (> or =1000 mg/day for > or =3 months) | double-blind Follow-up duration: 16 weeks |
| glitazone versus conventional treatment | |||
| PROactive, 2005 NCT00174993 | pioglitazone titrated 15-45 mg daily versus standard treatment | patients with type 2 diabetes who had evidence of macrovascular disease | double blind Follow-up duration: 34.5 months 19 countries |
| glulisine + glargine versus glulisine + glargine | |||
| OPAL, 2008 | single injection of glulisine before breakfast versus single injection of glulisine before their main mealtime (breakfast, lunch or dinner); | patients with type 2 diabetes who were suboptimally controlled on their previous glargine and OAD regimen | |
| glyburide versus c (add on MET) | |||
| DeFronzo, 1995 | metformin and glyburide versus metformin | patients with non-insulin-dependent diabetes mellitus | double-blind Follow-up duration: 29 weeks USA |
| Erle, 1999 | low-dose glyburide plus metformin versus high-dose glyburide alone | ||
| glyburide versus control (add on MET) | |||
| Blonde, 2002 | glyburide/metformin 2.5 mg/500 mg (n = 160); or glyburide/metformin 5 mg/500 mg (n = 162) versus metformin 500 mg | patients with inadequate glycaemic control on at least half-maximal dose of sulphonylurea | double-blind Follow-up duration: 16 weeks |
| Garber, 2003 | glyburide/metformin versus metformin | patients with type 2 diabetes who had inadequate glycemic control [glycosylated hemoglobin A(1C) (A1C), >7% and <12%) with diet and exercise alone | |
| glyburide versus placebo | |||
| Garber, 2002 | glyburide 2.5 mg versus placebo | patients with type 2 diabetes who had failed diet and exercise | double-blind |
| Vray, 1995 | glibenclamide (2.5 mg X 3/d) versus placebo | type 2 diabetic outpatients, 40-70 years of age, treated by diet alone or oral anti-diabetic drugs | double-blind China |
| insulin versus control | |||
| UGDP, | versus | ||
| UKPDS 33, | versus | ||
| insulin aspart at mealtimes versus NPH insulin once daily | |||
| Gram, 2011 | insulin aspart at mealtimes versus NPH insulin once daily at bedtime | ||
| insulin detemir versus glargine | |||
| Fadini, 2011 | versus | ||
| insulin detemir versus NPH insulin | |||
| Hermansen , | insulin detemir twice-daily versus NPH insulin | insulin-naive people with type 2 diabetes | Follow-up duration: 26 weeks |
| insulin glargine versus control | |||
| ORIGINE, 2012 NCT00069784 | insulin glargine (with a target fasting blood glucose level of ¡Ü95 mg per deciliter versus standard care | with cardiovascular risk factors plus impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes | Follow-up duration: 6.2 years |
| insulin glargine versus placebo | |||
| GRACE - ORIGIN (glargine), 2012 | insulin glargine (with a target fasting blood glucose level of <=95 mg per deciliter [5.3 mmol per liter]) versus standard glycemic care alone | subject with known CV disease and/or CV risk factors plus impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes | open-label |
| insulin glargine plus insulin glulisine versus premixed insulin analogues | |||
| Levin, 2011 | versus | ||
| insulin glulisine + glargine versus glargine once daily | |||
| Owens, 2011 | basal+bolus (single dose of insulin glulisine immediately prior to the main meal) versus basal insulin (glargin) | patients withT2DM using any basal insulin and HbA1c >7.0% after 3-month of insulin glargine titrated to optimize fasting bloodglucose control | open-label Follow-up duration: 3 months US, UK, Russia |
| insulin lispro protamine suspension plus lispro versus glargine plus lispro | |||
| Koivisto, 2011 | versus | ||
| intensive versus usual | |||
| ABCD normotensives, 1993 | intensive (10 mm Hg below the baseline DBP) DBP control versus moderate (80 to 89 mm Hg) DBP control | normotensive type 2 diabetic patients | open Follow-up duration: 5.3 y |
| ACCORD (blood pressure), 2010 NCT00000620 | intensive blood-pressure control, targeting a systolic pressure of less than 120 mm Hg versus standard blood-pressure control | high-risk patients with type 2 diabetes, high HbA1c concentrations (>7.5%), and cardiovascular disease (or >=2 cardiovascular risk factors) | open Follow-up duration: 4.7 y United States, Canada |
| HOT <=80 (diabetic subgroup), 1998 | target diastolic blood pressure <=80 mmHg versus target diastolic blood pressure <=90 mmHg | patients aged 50-80 years with hypertension and diastolic blood pressure between 100 mm Hg and 115 mm Hg; diabetics subgroup | open Follow-up duration: 3.8y 26 countries |
| intensive dietary advice versus routine dietary advice | |||
| Wein, 1999 | intensive dietary advice versus routine dietary advice | women with previous gestational diabetes and currently with impaired glucose tolerance (WHO 1985 criteria) | open Follow-up duration: 4.24 y USA |
| intensive glycemic control versus conventional treatment | |||
| ACCORD, 2008 NCT00000620 | very intensive glycemic control through currently available means (targetinga glycosylated hemoglobin <6%) during a mean of 3.7 years versus standard glycemic control (targeting a glycosylated hemoglobin 7.0-7.9%) | patients with type 2 diabetes mellitus at high risk of death and stroke (pre-existing heart disease or two or more additional risk factors for heart disease) | open Follow-up duration: 3.5y (5y) USA, Canada |
| ADDITION, 2010 NCT00237549 | intensive multifactorial treatment versus routine care | patients with newly diagnosed type 2 diabetes | open Follow-up duration: 5 year Denmark, United Kingdom, the Netherlands |
| ADVANCE, 2008 NCT00145925 | intensive glucose-lowering treatments HbA1C <=6.5% using gliclazide(modified release) plus other drugs versus standard glucose-lowering treatments (targetglycated hemoglobin levels defined on the basisof local guidelines) | patients with type 2 diabetes | open Follow-up duration: median 5 y 20 countries |
| Kumamoto (primary prev), 1995 | intensive glycemic control with multiple insulin injection treatment versus conventional insulin injection treatment (1-2 daily injections) | patients with non-insulin-dependent diabetes mellitus and with no retinopathy and urinary albumin excretions < 30 mg/24 h | open Follow-up duration: 8.0y Japan |
| Kumamoto (secondary prev), 1995 | multiple insulin injection treatment versus conventional insulin injection treatment (1-2 daily injections) | patients with non-insulin-dependent diabetes mellitus and simple retinopathy | open Follow-up duration: 8.0y Japan |
| Steno 2, 2003 | targeted, intensified, multifactorial intervention versus conventional treatment on modifiable risk factors for cardiovascular disease | patients with type 2 diabetes and microalbuminuria | open Follow-up duration: 7.8 y Denmark |
| UKPDS 33, 1998 | intensive policy with a sulphonylurea (chlorpropamide, glibenclamide, or glipizide) or with insulin; fasting plasma glucose <6.0 mmol/L versus conventional policy with diet | newly diagnosed patients with type 2 diabetes who after 3 months’ diet treatment had a mean of two fasting plasma glucose concentrations of 6·1–15·0 mmol/L | open Follow-up duration: 10.3 y UK |
| VA CSDM, 1997 | intensive glycemic control(stepped plan from 1 evening injection of insulin, alone or with glipizide, to multiple daily injections, target to attain near-normal glycemia levels) versus standard treatment (1 insulin injection every morning) | non-insulin-dependent diabetes mellitus patients | open Follow-up duration: 2.3y USA |
| VADT, 2008 NCT00032487 | intensive glucose control versus standard glucose control | military veterans who had a suboptimal response to therapy for type 2 diabetes | open Follow-up duration: 5.6y US |
| irbesartan versus amlodipine | |||
| IDNT (irbesartan vs amlodipine), 2001 | Irbesartan 300 mg daily versus amlodipine 10 mg daily | hypertensive patients with nephropathy due to type 2 diabetes | double blind Follow-up duration: 2.6 years Worldwide |
| irbesartan versus placebo | |||
| IDNT (irbesartan vs pbo), 2001 | Irbesartan 300 mg daily versus placebo | hypertensive patients with nephropathy due to type 2 diabetes | double blind Follow-up duration: 2.6 years Worldwide |
| IPDM (150mg), 2001 | irbesartan 150 mg daily versus placebo | hypertensive patients with type 2 diabetes and microalbuminuria | double-blind Follow-up duration: 2 years Worldwide |
| jiangtang bushen recipe versus control | |||
| Fan, 2004 | jiangtang bushen recipe 2-3 times/week versus placebo | patients with impaired glucose tolerance (WHO 1999 criteria) | open Follow-up duration: 4.1 y China |
| lifestyle modification versus control | |||
| DPS (Lindström), 2003 | individualized counseling aimed at reducing weight and intake of total and saturated fat, and increasing intake of fiber and physical activity versus control | Patients overweight with impaired glucose tolerance (WHO 1985 criteria) | open Follow-up duration: 3.2y Finnish |
| Fang, 2004 | standard prevention education versus | subject with impaired glucose tolerance | China |
| JDPP (Sakane), 2005 | lifestyle intervention versus | patients with impaired glucose tolerance (WHO 1999 criteria) | Japan |
| Keen, 1982 | either dietary teaching to restrict carbohydrate intake to 120 g/day or advice to restrict table sugar versus | subject with impaired glucose tolerance | |
| Kosaka, 2005 | to maintain body mass index (BMI) of <24.0 kg/m2 and of <22.0 kg/m2, respectively, by diet and exercise. In the intervention group, detailed instructions on lifestyle were repeated every 3-4 months versus control | men with impaired glucose tolerance (WHO criteria 1980) | open Follow-up duration: 3.64 y Japan |
| Pan, 1997 | three active treatment groups: diet only, exercise only, or diet plus exercise versus control | Patients with impaired glucosetolerance (WHO 1985 criteria) | open Follow-up duration: 6 y China |
| Tao, 2004 | lifestyle intervention versus | patients with impaired glucose tolerance (WHO 1999 criteria) | Follow-up duration: 31 months China |
| US-DDP (lifestyle) (Knowler), 2002 | lifestyle-modification intervention versus placebo | nondiabetic patients with elevated glucose and high risk for diabetes | open Follow-up duration: 2.8 years |
| lifestyle modification + metformin versus control | |||
| IDDP (Ramachandran), 2006 | advice on lifestyle modification, metformin, or both versus given standard health care advice (control) | native Asian Indians with impaired glucose tolerance | open Follow-up duration: 2.5 y India |
| Jarret, 1979 | carbohydrate restriction with phenformin 50 mg daily versus carbohydrate restriction alone | men with impaired glucose toleranc | open Follow-up duration: 4.3 y |
| linagliptin versus glimepiride | |||
| CAROLINA, 2012 NCT01243424 | linagliptin versus glimepiride 1-4 mg QD | patients with type 2 diabetes at elevated cardiovascular risk receiving usual care | double-blind Follow-up duration: 2 years USA |
| linagliptin versus glimepiride (add on MET) | |||
| Gallwitz, 2012 NCT00622284 | linagliptin (5 mg once daily) add-on therapy to preferably > 1500 mg metformin versus glimepiride (1—4 mg) orally once daily add-on therapy to preferably > 1500 mg metformin | type 2 diabetes mellitus with insufficient glycaemic control with metformin | double-blind Follow-up duration: 104 weeks USA |
| linagliptin versus Metformin + sulfonylurea | |||
| Owens, 0 NCT00602472 | linagliptin
versus combination of metformin and an SU | type 2 diabetes mellitus with insufficient glycaemic control with metformin in combination with a sulphonylurea | Follow-up duration: 24 weeks Argentina |
| linagliptin versus placebo | |||
| Del Prato, 0 NCT00621140 | Linagliptin monotherapy
versus placebo | Type 2 Diabetic Patients With Insufficient Glycemic Control | double-blind Follow-up duration: 24 weeks Croatia |
| linagliptin versus placebo (add on MET) | |||
| Taskinen, 0 NCT00601250 | linagliptin 5 mg once daily versus placebo add on MET | patients with inadequately controlled type 2 diabetes for whom metformin therapy is inappropriate due to intolerability or contraindication | |
| linagliptin versus placebo (add on pioglitazone) | |||
| Gomis, 2011 NCT00641043 | initial combination of 30 mg pioglitazone plus 5 mg linagliptin versus pioglitazone plus placebo | patients with inadequately controlled type 2 diabetes | Follow-up duration: 24 weeks |
| linagliptin versus placebo (add on SU) | |||
| Lewin, 2010 NCT00819091 | linagliptin 5 mg
versus placebo (add-on to sulphonylurea) | patients with type 2 diabetes and insufficient glycaemic control | double-blind Follow-up duration: 18 weeks |
| liraglutide versus placebo | |||
| LEADER, 2016 NCT01179048 | Maximum dose of 1.8 mg liraglutide, injected subcutaneously once daily versus placebo | subjects with type 2 diabetes | double-blind Follow-up duration: 3.8 years (median) Africa, Asia, Europe, North and South America |
| liraglutide 1.2mg versus glimepiride | |||
| LEAD-3 mono 1.2mg (Garber), 2009 NCT00294723 | liraglutide 1.2 mg daily
versus glimepiride 8 mg once daily | patients with early type 2 diabetes | double blind Follow-up duration: 52 weeks (104 weeks) North America, Mexico |
| liraglutide 1.2mg versus glimepiride (add on MET) | |||
| LEAD-2 (Nauck) (1.2 mg vs glimepiride), 2009 NCT00318461 | Liraglutide 1.2mg daily for 26 weeks versus Glimepiride on-top of Metformin | patients with type 3 diabetes previously treated with oral antidiabetes (OAD) therap | double blind Follow-up duration: 26 weeks 21 countries |
| liraglutide 1.2mg versus placebo (add on MET) | |||
| LEAD-2 (Nauck) (1.2mg vs placebo), 2009 NCT00318461 | Liraglutide 1.2 mg daily
versus Placebo on-top of Metformin | subjects previously treated with oral antidiabetes therapy | double blind Follow-up duration: 26 weeks 21 countries |
| liraglutide 1.2mg versus placebo (add on SU) | |||
| LEAD-1 SU (1.2 mg vs placebo), 2009 NCT00318422 | Liraglutide 1.2 mg daily
versus Placebo on-top of sulphonylureas | subjects with Type 2 diabetes | double-blind Follow-up duration: 26 weeks 21 countries |
| liraglutide 1.2mg versus placebo (add on TZD+MET) | |||
| LEAD-4 (1.2mg), 2009 NCT00333151 | Liraglutide 1.2 daily versus Placebo on-top of thiazolidinediones + metformin | patients with type 2 diabetes, A1C 7–11% (previous OAD monotherapy >=3 months) or 7–10% (previous OAD combination therapy >=3 months), and BMI 45 kg/m2 | double-blind Follow-up duration: 26 weeks USA, Canada |
| liraglutide 1.2mg versus rosiflitazone | |||
| LEAD-1 SU (1.2 vs rosiglitazone), 2009 | versus | ||
| liraglutide 1.2mg versus sitagliptin | |||
| Pratley 1.2mg, 2010 NCT00700817 | liraglutide 1.2mg subcutaneously once daily versus oral sitagliptin 100mg once daily | patients with type 2 diabetes who did not have adequate glycemic control with metformin | open Follow-up duration: 26 weeks Europe, USA, Canada |
| liraglutide 1.8mg versus exenatide on top MET/SU/MET+SU | |||
| LEAD-6, 2009 NCT00518882 | liraglutide 1.8 mg once a day versus exenatide 10 microg twice a day | Adults with inadequately controlled type 2 diabetes on maximally tolerated doses of metformin, sulphonylurea, or both | open Follow-up duration: 26 weeks 15 countries |
| liraglutide 1.8mg versus glimepiride | |||
| LEAD-3 mono 1.8mg (Garber), 2009 NCT00294723 | liraglutide 1.8 mg daily
versus glimepiride 8 mg once daily | subjects with type 2 diabetes | double blind Follow-up duration: 52 weeks (104 weeks) North America, Mexico |
| liraglutide 1.8mg versus glimepiride (add on MET) | |||
| LEAD-2 (Nauck) (1.8 mg vs glimepiride), 2009 NCT00318461 | Liraglutide 1.8 mg daily for 26 weeks
versus Glimepiride on-top of Metformin | patients with type 3 diabetes previously treated with oral antidiabetes (OAD) therap | double blind Follow-up duration: 26 weeks 21 countries |
| liraglutide 1.8mg versus insulin glargine (add on SU+MET) | |||
| LEAD-5 (vs Glargine), 2009 NCT00331851 | Liraglutide 1.8 mg daily versus Glargine on-top of sulphonylureas+metformin | adult patients with type 2 diabetes | open Follow-up duration: 26 weeks 17 countries |
| liraglutide 1.8mg versus liraglutide 1.2mg | |||
| LEAD 1 (1.8 vs 1.2), 2009 | versus | ||
| LEAD 2 (1.8 vs 1.2), 2009 | versus | ||
| LEAD 4 (1.8 vs 1.2), 2009 | versus | ||
| Pratley (1.8 vs 1.2), 2010 | versus | ||
| liraglutide 1.8mg versus placebo (add on MET) | |||
| LEAD-2 (Nauck) (1.8mg vs placebo), 2009 NCT00318461 | Liraglutide 1.8 mg daily
versus Placebo on-top of Metformin | subjects previously treated with oral antidiabetes therapy | double blind Follow-up duration: 26 weeks 21 countries |
| liraglutide 1.8mg versus placebo (add on SU) | |||
| LEAD-1 SU (1.8 mg vs placebo), 2009 NCT00318422 | Liraglutide 1.8 mg daily
versus Placebo on-top of sulphonylureas | patients with type 2 diabetes | double-blind Follow-up duration: 26 weeks 21 countries |
| liraglutide 1.8mg versus placebo (add on SU+MET) | |||
| LEAD-5 (vs placebo), 2009 NCT00331851 | Liraglutide 1.8 mg daily
versus Placebo on-top of sulphonylureas+metformin | adult patients with type 2 diabetes | double-blind Follow-up duration: 26 weeks 17 countries |
| liraglutide 1.8mg versus placebo (add on TZD+MET) | |||
| LEAD-4 (1.8mg), 2009 NCT00333151 | Liraglutide 1.8 daily
versus Placebo on-top of thiazolidinediones + metformin | patients with type 2 diabetes, A1C 7–11% (previous OAD monotherapy >=3 months) or 7–10% (previous OAD combination therapy >=3 months), and BMI 45 kg/m2 | double-blind Follow-up duration: 26 weeks USA, Canada |
| liraglutide 1.8mg versus sitagliptin | |||
| Pratley 1.8mg, 2010 NCT00700817 | liraglutide 1.8mg subcutaneously once daily
versus oral sitagliptin 100mg once daily | patients with type 2 diabetes who did not have adequate glycemic control with metformin | open Follow-up duration: 26 weeks Europe, USA, Canada |
| liraglutide other doses versus glibenclamide | |||
| Seino, 2010 NCT00393718 | liraglutide 0.9 mg once daily versus glibenclamide once or twice daily at a planned maximum dose of 2.5 mg/day, before or after meals | Japanese subjects with type 2 diabetes, inadequately controlled with diet therapy or oral antidiabetic drug monotherapy | double-blind Follow-up duration: 24-week Japan |
| liraglutide other doses versus glimepiride | |||
| Madsbad (vs Glimepiride), 2004 | Liraglutide 0.045, 0.225, 0.45, 0.60, and 0.75 mg daily versus Glimepiride | Outpatients with type 2 diabetes | open Follow-up duration: 12 weeks UK, Scandinavia |
| liraglutide other doses versus metformin | |||
| Feinglos, 2005 | Liraglutide 0.045, 0.225, 0.45, 0.6 or 0.75 mg daily for 12 weeks versus metformin 1000mg twice daily | subjects with Type 2 diabetes | double blind (not adequate) Follow-up duration: 12 weeks |
| liraglutide other doses versus placebo | |||
| Harder, 2004 | single daily subcutaneous dose of 0.6 mg liraglutide for 8 weeks versus placebo | obese subjects with type 2 diabetes | double-blind Follow-up duration: 8 weeks Denmark |
| Kaku 0.6mg, 2010 | liraglutide 0.6 mg/day versus placebo | Japanese patients with type 2 diabetes | double-blind Follow-up duration: 24 weeks Japan |
| Madsbad (vs placebo), 2004 | Liraglutide 0.045, 0.225, 0.45, 0.60, and 0.75 mg daily
versus Placebo | Outpatients with type 2 diabetes | open Follow-up duration: 12 weeks UK, Scandinavia |
| NN2211-1571 (Vilsbøll), 2007 NCT00154401 | liraglutide 0.65 mg, 1.25 mg or 1.9 mg for 14 weeks
versus placebo | subjects with type 2 diabetes | double-blind Follow-up duration: 14 weeks Denmark, France, Slovakia, Netherlans |
| Seino, 2008 NCT00154414 | Liraglutide 0.1, 0.3, 0.6 or 0.9 mg once daily for 14 weeks
versus Placebo | Japanese subjects with type 2 diabetes | double blind Follow-up duration: 14 weeks Japan |
| liraglutide other doses versus placebo (add on MET) | |||
| NN2211-1796, 0 NCT00614120 | liraglutide added to metformin versus glimepiride added to metformin | China | |
| liraglutide other doses versus placebo (on top SU) | |||
| Kaku 0.9mg, 2010 | liraglutide 0.9 mg/day
versus placebo | Japanese patients with type 2 diabetes | double-blind Follow-up duration: 24 weeks Japan |
| liraglutide other doses versus rosiglitazone (add on SU) | |||
| LEAD-1 SU (1.8 vs rosiglitazone), 2009 NCT00318422 | Liraglutide 0.6, 1.2 or 1.8 mg daily
versus rosiglitazone on-top of sulphonylureas | double-blind Follow-up duration: 26 weeks 21 countries | |
| lisinopril versus chlorthalidone | |||
| ALLHAT (lisi vs chlor, diabetic subgroup), 2002 | lisinopril 10 to 40 mg/d versus chlorthalidone 12.5 to 25 mg/d | diabetic (subgroup) participants aged 55 years or older with hypertension | double-blind Follow-up duration: 4.9 y |
| lispro versus glargine once-daily | |||
| APOLLO (Bretzel), 2008 NCT00311818 | nsulin lispro administered three times per day versus insulin glargine taken once daily at the same time every day | type 2 diabetes mellitus that was inadequately controlled by oral hypoglycaemic agents | |
| lispro versus insulin detemir | |||
| Fogelfeld, 2010 | Insulin lispro protamine suspension versus insulin detemir once daily at bedtime | insulin-naive patients with Type 2 diabetes | open-label Follow-up duration: 24 week |
| lispro + NPH versus NPH + SU | |||
| Bastyr, 1999 | preprandial insulin lispro plus bedtime NPH insulin versus bedtime neutral protamine Hagedorn (NPH) insulin plus sulfonylurea | ||
| lispro + NPH versus NPH twice daily | |||
| Ceriello, 2007 | premeal insulin lispro+bedtime neutral protamine Hagedorn (NPH) versus twice-daily NPH | patients with type 2 diabetes treated by a 2-month lead-in with twice-daily NPH treatment | open-label Follow-up duration: 12 weeks |
| lispro +glargine versus continuous infusion | |||
| Herman, 2005 | multiple daily injection using insulin lispro and insulin glargine versus continuous subcutaneous insulin infusion using insulin lispro | ||
| lispro insulin versus NPH insulin | |||
| Bastyr, 2000 | insulin lispro versus bedtime NPH insulin | ||
| lispro insulin + NPH insulin versus regular insulin + NPH insulin | |||
| Altuntas, 2003 | lispro insulin + NPH insulin versus regular insulin + NPH insulin | ||
| lispro mixture versus glargine once daily | |||
| Chan META-ANALYSIS, 2009 | insulin lispro mixtures, given twice or thrice daily versus insulin glargine, given once daily | patients with type 2 diabetes treated with metformin | |
| lispro PS versus glargine | |||
| Strojek, 2010 | insulin lispro protamine suspension (ILPS) once or twice daily versus insulin glargine once daily | open-label | |
| lispro thrice daily versus basal insulin | |||
| Raz, 2009 | three premeal doses of insulin lispro versus NPH twice daily or insulin glargine once daily | patients with type 2 diabetes after acute myocardial infarction | |
| lispro twice daily + NPH insulin versus regular insulin + NPH insulin | |||
| Vignati, 0 | twice-daily insulin lispro in combination with NPH human insulin versus regular human insulin in combination with NPH human insulin | ||
| lixisenatide versus glargine once daily | |||
| GETGOAL-L, 0 NCT00715624 | AVE0010 (10,15 and 20 µg) in association with basal insulin, with or without metformin versus placebo on top basal insulin | Type 2 diabetes mellitus insufficiently controlled with basal insulin with or without metformin | double-blind Follow-up duration: 24 weeks USA |
| lixisenatide versus placebo | |||
| ELIXA, NCT01147250 | lixisenatide versus placebo | patients with T2DM and a recent ACS event | double-blind Follow-up duration: 25 months (median) 49 countries |
| lixisenatide versus placebo (add on basal insulin) | |||
| GETGOAL-L, 0 NCT00715624 | AVE0010 (10,15 and 20 µg) in association with basal insulin, with or without metformin versus placebo on top basal insulin | Type 2 diabetes mellitus insufficiently controlled with basal insulin with or without metformin | double-blind Follow-up duration: 24 weeks USA |
| lixisenatide versus placebo (add on MET) | |||
| Ratner DRI6012, 2010 NCT00299871 | subcutaneous lixisenatide doses of 5, 10, 20 or 30 microg once daily or twice daily versus placebo | patients with Type 2 diabetes inadequately controlled with metformin (>= 1000 mg/day) | double-blind (nature not volume) Follow-up duration: 13 weeks multinational |
| losartan versus atenolol | |||
| LIFE (diabetic subgroup), 2002 | losartan 50mg daily at step 1 versus atenolol 50mg daily at step 1 | patients with diabetes (subgroup) , hypertension, and signs of left-ventricular hypertrophy on electrocardiograms | double-blind Follow-up duration: 4.7 years USA, UK, Nordic countries |
| losartan versus placebo | |||
| RENAAL, 2001 | losartan 50 to 100 mg once daily versus placebo | patients with type 2 diabetes and nephropathy | double-blind Follow-up duration: 3.4 y America, Europe, Asia |
| lovastatin versus placebo | |||
| AFCAPS/TexCAPS (diabetic sub group), 1998 | lovastatin versus placebo | men and women without clinically evident atherosclerotic cardiovascular disease with average total cholesterol (TC) and LDL-C levels and below-average high-density lipoprotein cholesterol (HDL-C) levels | double blind |
| metformin versus Acarbose | |||
| Maji vs acarbose, | 500 versus Acarbose | Follow-up duration: 156 | |
| metformin versus control | |||
| James, 2005 | metformin 1 g BID versus no treatment | Abdominal obesity with insulin resistance[ | Follow-up duration: 8 weeks |
| metformin versus Glibenclamide | |||
| Yki-Yarvinen vs glibenclamide, 1999 | 2.000 versus Glibenclamide | Follow-up duration: 52 | |
| Kahn (ADOPT) vs glibenclamide, | 2.000 versus Glibenclamide | Follow-up duration: 208 | |
| metformin versus Glimepiride | |||
| Yamanouchi vs glimepiride, 2005 | 750 versus Glimepiride | Follow-up duration: 52 | |
| metformin versus Glipizide | |||
| Campbell, 1994 | 1.000 versus Glipizide | Follow-up duration: 52 | |
| Stakos vs glipizide, | 500 versus Glipizide | Follow-up duration: 104 | |
| metformin versus Glipizide/ | |||
| Vahatalo vs glipizide/glimepiride, | 2.500- versus Glipizide/ | Follow-up duration: 52 | |
| metformin versus Insulin | |||
| Yki-Yarvinen vsinsulin, | 2.000 versus Insulin | Follow-up duration: 52 | |
| Klein, 1991 | 2.550 versus Insulin | Follow-up duration: 52 | |
| Barnett, 2008 | NR versus Insulin | Follow-up duration: 128 | |
| metformin versus None | |||
| Vahatalo vs control, 2007 | 2.500 versus None | Follow-up duration: 52 | |
| Maji vs control, 2005 | 500 versus None | Follow-up duration: 156 | |
| UKPDS 34 vs control, | 2.550 versus None | Follow-up duration: 556 | |
| UKPDS 34 bis, | 2.550 versus None | Follow-up duration: 343 | |
| Zhang, | 750 versus None | Follow-up duration: 76 | |
| Ramachandran, | 500 versus None | Follow-up duration: 156 | |
| metformin versus Pioglitazone | |||
| Yamanouchi vs pioglitazone, 0 | 750 versus Pioglitazone | Follow-up duration: 52 | |
| Shernthaner, 2004 | 2.000 versus Pioglitazone | Follow-up duration: 52 | |
| Derosa, 2009 | 3.000 versus Pioglitazone | Follow-up duration: 64 | |
| Charbonnel, 2005 | 2.550 versus Pioglitazone | Follow-up duration: 104 | |
| metformin versus placebo | |||
| Baillargeon, 2004 | metformin 850 mg BID versus placebo | Non obese women with PCOS | Follow-up duration: 26 weeks |
| Hermann, 2001 | metformin 1.700 versus Placebo | obese and overweight type 2 diabetes patients treated with insulin for at least 1 year, and with poor glycaemic control (HbA1c > upper reference level + 2%) | double-blind Follow-up duration: 52 weeks |
| Bridger, 2006 | metformin 750 mg BID versus placebo | Adolescents with PCOS and insulin resistance | Follow-up duration: 12 weeks |
| Charles, 1998 | metformin 850 mg BID versus placebo | Abdominal obesity | Follow-up duration: 52 weeks |
| Charles, 2000 | metformin 850 mg BID versus placebo | Abdominal obesity, hypertension, and elevated triglycerides | Follow-up duration: 13 weeks |
| Choux, 2003 | metformin 500 mg TID versus placebo | PCO | Follow-up duration: 13 weeks |
| Crave, 1995 | metformin 850 mg BID versus placebo | Overweight with PCO | Follow-up duration: 17 weeks |
| EDIT (Holman), 2003 | metformin 500 mg three times/day, versus placebo | (WHO 1985 criteria) | UK |
| Douek, 2005 | 2.000 versus Placebo | Follow-up duration: 52 | |
| HOME, 2009 NCT00375388 | metformin 850 mg versus placebo | patients with DM2 treated with insulin | double-blind Follow-up duration: 4.3 y The Netherlands |
| Fleming, 2002 | metformin 850 mg BID versus placebo | PCO | Follow-up duration: 17 weeks |
| Gregorio, 1999 | 1.700 versus Placebo | Follow-up duration: 76 | |
| Freemark, 2001 | metformin 500 mg BID versus placebo | Insulin resistance and family history of diabetes | Follow-up duration: 26 weeks |
| Teupe, 1991 | 1.700 versus Placebo | Type 2 diabetic patients | open Follow-up duration: 104 Canada |
| Gambineri, 2004 | metformin 850 mg BID versus placebo | Obesity and PCOS | Follow-up duration: 26 weeks |
| Giugliano, 1993 | metformin 850 mg BID versus placebo | Hypertension with normal glucose tolerance | Follow-up duration: 12 weeks |
| Hoeger, 2004 | metformin 850 mg BID + lifestyle modification versus placebo + lifestyle modification | Overweight with PCOSo[ | Follow-up duration: 48 weeks |
| Kooy (HOME), 2009 | 2.000 versus Placebo | Patients with type 2 diabetes | double blind Follow-up duration: 220 |
| Kay, 2001 | metformin 850 mg BID versus placebo | Adolescents with morbid obesity | Follow-up duration: 8 weeks |
| Kelly, 2002 | metformin 500 mg TID versus placebo | PCO | Follow-up duration: 26 weeks |
| Kocak, 2002 | metformin 850 mg BID versus placebo | PCO | Follow-up duration: 8 weeks |
| Lehtovirta, 2001 | metformin 500 mg BID versus placebo | Overweight with impaired glucose tolerance and family history of diabetes | Follow-up duration: 26 weeks |
| palomba, | 1.700 versus Placebo | Follow-up duration: 52 | |
| Ibanez, | 850 versus Placebo | Follow-up duration: 52 | |
| Harborne, | 1.500 versus Placebo | Follow-up duration: 52 | |
| Li, 1999 | metformin 250 mg three times/day versus placebo | patients with impaired glucose tolerance (WHO 1985 criteria) | double blind Follow-up duration: 12 months China |
| Li, | 2.000 versus Placebo | Follow-up duration: 52 | |
| Moghetti, 2000 | metformin 500 mg TID versus placebo | PCOS with normal glucose tolerance | Follow-up duration: 26 weeks |
| Martinez, | 1.700 versus Placebo | Follow-up duration: 52 | |
| Morel, 1999 | metformin 850 mg BID versus placebo | Impaired glucose tolerancee | Follow-up duration: 8 weeks |
| Gambineri, | 1.700 versus Placebo | Follow-up duration: 52 | |
| Lund, | 2.000 versus Placebo | Follow-up duration: 52 | |
| BIGPRO (Charles), | 1.700 versus Placebo | Follow-up duration: 52 | |
| Ng, 2001 | metformin 500 mg TID versus placebo | PCO | Follow-up duration: 12 weeks |
| Orchard, 2005 | metformin 850 mg BID versus placebo | Impaired glucose tolerance | Follow-up duration: 156 weeks |
| Stakos vs placebo, | 500 versus Placebo | Follow-up duration: 104 | |
| Shuster, | 500 versus Placebo | Follow-up duration: 104 | |
| Pasquali, 2000 | metformin 850 mg BID versus placebo | Abdominal obesity with and without PCO | Follow-up duration: 26 weeks |
| DPP (Knowler), | 1.700 versus Placebo | Follow-up duration: 156 | |
| Ibanez 62, 0 | 425 versus Placebo | Follow-up duration: 208 | |
| Rodriguez, 2004 | metformin 1.7 g/d versus placebo | Obesity with insulin resistance | Follow-up duration: 20 weeks |
| Rodriguez-Moctezuma, 2004 | metformin 850 mg BID versus placebo | Family history of diabetes | Follow-up duration: 8 weeks |
| Sirtori, 1984 | metformin 850 mg BID versus placebo | Peripheral vascular disease | Follow-up duration: 26 weeks |
| Srinivasan, 2006 | metformin 1 g BID versus placebo | Children and adolescents with obesity and insulin resistance | Follow-up duration: 26 weeks |
| Stakos, 2005 | metformin 500 mg/d versus placebo | African-Americans with insulin resistance and family history of diabetes | Follow-up duration: 104 weeks |
| Sturrock, 2002 | metformin 1500 mg/d versus placebo | PCO | Follow-up duration: 13 weeks |
| Tang, 2006 | metformin 850 mg BID versus placebo | Obesity with PCO | Follow-up duration: 26 weeks |
| US-DPP (metformin) (Knowler), 2002 | metformin 850mg twice daily versus placebo | nondiabetic patients with elevated glucose and high risk for diabetes | double blind Follow-up duration: 2.8 years USA |
| Vitale, 2005 | metformin 500 mg BID versus placebo | Metabolic syndrome | Follow-up duration: 13 weeks |
| metformin versus Rosiglitazone | |||
| maji vs rosiglitazone, | 500 versus Rosiglitazone | Follow-up duration: 156 | |
| ADOPT vs rosiglitazone, | 2.000 versus Rosiglitazone | Follow-up duration: 208 | |
| RECORD, | 2.550 versus Rosiglitazone | Follow-up duration: 260 | |
| Tomazic, | 1.000 versus Rosiglitazone | Follow-up duration: 52 | |
| metformin versus SU/Insulin | |||
| UKPDS (vs SU or INS), 0 | 2.550 versus SU/Insulin | Type 2 diabetic patients | open Follow-up duration: 556 UK |
| metformin versus Vildagliptin | |||
| Schweizer, 2007 | 2.000 versus Vildagliptin | Follow-up duration: 52 | |
| metformin + repaglinide versus repaglinide | |||
| AGEE-1411, 0 NCT01465152 | metformin and repaglinide versus repaglinide | subjects with type 2 diabetes in which diet and exercise have failed | open Follow-up duration: 24 weeks Spain |
| metoprolol versus placebo | |||
| MERIT-HF, 2005 | metoprolol CR/XL versus placebo | patients with CHF NYHA classe 2 to 4 and EF<=40% sub group of diabetic patients | double-blind Follow-up duration: 1y USA and Europe |
| miglitol versus placebo (add on to met) | |||
| Van Gaal, 2001 | miglitol force-titrated: 4 weeks at 25 mg miglitol t.i.d., 12 weeks at 50 mg miglitol t.i.d., and 16 weeks at 100 mg miglitol t.i.d. versus placebo | type 2 diabetic outpatients insufficiently controlled (HbA1c between 7.5 and 10.5%) with diet and metformin | double-blind Follow-up duration: 32 weeks |
| mitiglinide versus nateglinide | |||
| Gao, 0 NCT00461617 | mitiglinide 10 - 20 mg three times daily versus nateglinide 120 mg three times daily | Chinese type 2 diabetes mellitus patients | double-blind Follow-up duration: 20 weeks |
| mitiglinide versus on top insulin glargine | |||
| Kumashiro, 2007 | mitiglinide versus on top of once daily insulin glargine | ||
| mitiglinide versus placebo (add on MET) | |||
| NCT01037842, NCT01037842 | mitiglinide versus placebo | patients with type 2 diabetes who show inadequate glycemic control with metformin monotherapy | double-blind Follow-up duration: 16 weeks Korea |
| EX-1510-CT-003, 0 NCT00519142 | metformin + mitiglinide three times a day with meals versus (metformin + placebo for mitiglinide | patients with Type 2 diabetes mellitus not well controlled with metformin alone | double-blind Follow-up duration: 24 weeks US |
| mitiglinide versus placebo (on top pioglitazone) | |||
| Kaku, 2009 | additional mitiglinide 5 or 10 mg tid versus placebo on top pioglitazone | Japanese type 2 diabetic patients who are insufficiently controlled by pioglitazone monotherapy | multicenter Follow-up duration: 16 weeks |
| mitiglinide+voglibose versus insulin glargine | |||
| GLORIA, 0 NCT00663884 | combination therapy of 10 mg mitiglinide or 0.2mg voglibose versus insulin glargine | diabetic patients whose glycemic control were not enough despite administration of oral antidiabetic drug or insulin glargine | open Follow-up duration: 16 weeks Korea |
| Mix 25/75 versus glargine once-daily | |||
| Roach, 2006 | insulin lispro mixture (25% insulin lispro and 75% NPL;
Mix 25/75) twice-daily plus oral glucose-lowering medications (metformin and/
or sulphonylurea) versus once-daily insulin glargine plus oral agents | patients with Type 2 diabetes inadequately controlled with insulin and/or oral glucose-lowering agents | |
| more intensive blood pressure lowering strategie versus less intensive blood pressure lowering strategie | |||
| ABCD target (H) , 2000 | intensive treatment with a diastolic blood pressure
goal of 75 mmHg versus moderate treatment with a diastolic blood pressure goal of 80-89 mmHg | diabetes patients with DBP >=90 mmHg | open Follow-up duration: 5 year |
| ABCD target (N) , 2002 | intensive treatment (diastolic blood pressure decrease
of 10 mmHg below baseline DBP) versus moderate treatment (diastolic blood pressure goal of 80-89 mmHg) | diabetes patients with diastolic blood pressure between 80 and 89mmHg | open |
| morning insulin glargine versus bedtime insulin glargine | |||
| Fritche , | morning insulin glargine versus bedtime insulin glargine | patients with type 2 diabetes previously treated with oral antidiabetic agents | open Follow-up duration: 24 weeks |
| n-3 fatty acid supplement versus placebo | |||
| GRACE - ORIGIN (n-3 fatty acid), | n-3 fatty acid supplemen versus placebo | subjects with known CV disease and/or CV risk factors plus impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes | double-blind Follow-up duration: 4.9y (median) |
| nateglinide versus glibenclamide (add on MET) | |||
| Derosa , 2009 | nateglinide versus glibenclamide | naïve type 2 diabetic patients treated with metformin | double-blind Follow-up duration: 12 months |
| nateglinide versus gliclazide (add on MET) | |||
| Ristic, 2006 | nateglinide plus metformin versus gliclazide plus metformin | Patients with inadequate glucose control on maximal doses of metformin | double-blind Follow-up duration: 24 weeks |
| nateglinide versus glyburide (add on MET) | |||
| PRESERVE-beta, | versus | ||
| nateglinide versus placebo | |||
| CDJN608AUS13 , | versus | ||
| CDJN608AUS13 , | versus | ||
| CDJN608A ES03, | versus | ||
| NAVIGATOR, | versus | patients with impaired glucose toler-ance (IGT) | |
| Schwarz , 2008 | nateglinide monotherapy (120 mg, before meals) versus placebo | drug-naïve patients with T2DM aged >or=65 years | double-blind Follow-up duration: 12 weeks |
| Schwarz (study 2), 2008 | nateglinide monotherapy (120 mg, before meals)
versus | drug-naïve patients with T2DM aged >or=65 years | double-blind Follow-up duration: 12 weeks |
| NAVIGATOR nateglinide, 2010 NCT00097786 | nateglinide 60mg 3 times daily versus placebo | subjects with impaired glucose tolerance and either CV disease or CV risk factors | double-blind Follow-up duration: 5 years 40 countries |
| Hanefeld, 1990 | nateglinide at doses of 30 mg, 60 mg, 120 mg, or 180 mg versus placebo | double-blind Follow-up duration: 12 weeks | |
| Horton, 2000 | 120 mg nateglinide before meals versus placebo | patients with an HbA1c level between 6.8 and 11.0% during a 4-week placebo run-in | double-blind |
| Mari, 2005 | 30, 60, or 120 mg nateglinide versus placebo | mild type 2 diabetic men and women (fasting glucose 7.0-8.3 mmol/l) on diet treatment | double_blind Follow-up duration: 24 weeks |
| Marre, 2002 | nateglinide 60 mg, 120 mg before three meals versus placebo | metformin-treated patients with HbA1c between 6.8% and 11% | double-blind |
| Moses, 2001 | 0.5 mg repaglinide at mealtimes (increased to 1 mg after 4 weeks depending on blood glucose response) versus placebo | patients with type 2 diabetes considered poorly controlled by diet, but without a history of previous antidiabetic medication | double-blind Follow-up duration: 16 weeks |
| Saloranta, 2002 | nateglinide (30, 60, or 120 mg, with meals). versus placebo | patients with type 2 diabetes but only moderately elevated fasting plasma glucose (FPG = 7.0-8.3 mmol/liter) | double-blind Follow-up duration: 24 weeks |
| nateglinide versus placebo (add on insulin) | |||
| Dashora , 2007 | nateglinide before meals versus placebo | double-blind Follow-up duration: 16 weeks | |
| nateglinide versus placebo (add on insulin+MET) | |||
| Juurinen , 2009 | nateglinide (120 mg three times daily) before main meals versus placebo (add on insulin+MET) | Type 2 diabetes treated with the combination of basal insulin and metformin | double-blind Follow-up duration: 24 weeks |
| nateglinide versus placebo (add on standard treatment) | |||
| NCT00402909, NCT00402909 | adding nateglinide to treatment with basal insulin glargine, metformin and/or thiazolidinedione (pioglitazone or rosiglitazone) versus | patients with type 2 diabetes who are not achieving glycemic control with glargine, metformin and/or thiazolidinedione only | double-blind |
| nateglinide versus repaglinide | |||
| Rosenstock , 2004 | nateglinide monotherapy versus repaglinide monotherapy | type 2 diabetic patients previously treated with diet and exercise | open Follow-up duration: 16 week |
| Li, 2009 | Nateglinide versus repaglinide | ||
| Li, 2007 | nateglinide 90 mg three times daily versus repaglinide 1.0 mg three times daily | Chinese patients with type 2 diabetes | Follow-up duration: 12 weeks |
| nateglinide + metformin versus metformin | |||
| Horton DOUBLON, 2000 | nateglinide (120 mg, ac) and metformin (500 mg, tid) versus 500 mg metformin three times a day | Follow-up duration: 24 weeks | |
| nifedipine versus ACE inhibitor | |||
| JMIC-B (diabetic subgroup), 2004 | nifedipine retard versus angiotensin converting enzyme inhibitors | outpatients aged under 75 years who had diagnoses of both hypertension and coronary artery disease | open Follow-up duration: 3 years Japan |
| nifedipine versus coamilozide | |||
| INSIGHT (diabetic subgroup), 2000 | Nifedipine GITS 30 mg daily versus co-amilozide hydrochlorothiazide 25 mg plus amiloride 2.5 mg | diabetic (subgroup) patients aged 55-80 years with hypertension (blood pressure >= 150/95 mm Hg, or >= 160 mmHg systolic) | double-blind Follow-up duration: 4 y Europe, Israel |
| nifedipine versus placebo | |||
| ACTION, 1998 | Nifedipine GITS versus placebo | patients aged at least 35 years with stable angina pectoris and proven coronary artery disease; subgroup of diabetic patients | double-blind Follow-up duration: 4.9y 19 countries |
| nisoldipine versus enalapril | |||
| ABCD (hypertension), 1998 | nisoldipine (long acting) versus enalapril | patients with non-insulin-dependent diabetes and hypertension | Double blind Follow-up duration: 5 y USA |
| nitrendipine versus placebo | |||
| Syst-Eur (diabetic subgroup), 1999 | Calcium-channel blocker versus placebo | subgroup of diabetic patients, age, >=60 years) with systolic blood pressure of 160 to 219 mm Hg and diastolic pressure below 95 mm Hg | double blind Follow-up duration: 2 years |
| NPH + GLIM versus lispro mix | |||
| Milicevic, 2009 | bedtime neutral protamine Hagedorn (NPH) insulin plus maximally tolerated dose of glibenclamide BID versus insulin lispro mix 50 pre-breakfast and lispro mix 25 pre-dinner | patients inadequately controlled with oral antihyperglycemic medications | open-label |
| olmesartan versus placebo | |||
| ROADMAP, 2010 NCT00185159 | olmesartan at 40 mg/day versus placebo | patients with diabetes and at least one additional cardiovascular risk factor, but no evidence of renal dysfunction | double-blind Follow-up duration: 3.2 y Europe (19 countries) |
| ORIENT, NCT00141453 | olmesartan versus placebo | patients with diabetic Nephropathy and overt proteinuria secondary to type 2 diabetes mellitus | double-blind Japan, Hong Kong |
| orlistat versus placebo | |||
| Heymsfield, 2000 | orlistat 120 mg three times/day versus placebo | obese (body mass index, 30-43 kg/m2) adults (WHO 1985 criteria) | double blind Follow-up duration: 4 weeks USA, Europe |
| XENDOS (Chiasson), 2002 | orlistat 120 mg three times/day versus placebo | patients with impaired glucose tolerance (WHO 1994) | double blind Follow-up duration: 3 months Sweden |
| perindopril versus placebo | |||
| EUROPA (PERSUADE substudy), 2005 | perindopril 8mg once daily versus placebo | patients with known coronary artery disease and without heart failure, sub group of diabetic patients | double-blind Follow-up duration: 4.3y |
| PROGRESS (diabetic subgroup), 2001 | perindopril 4 mg daily versus placebo | hypertensive and non-hypertensive individuals with cerebrovascular disease, subgroup of diatebic patients | double-blind Follow-up duration: 3.9 y |
| perindopril and indapamide versus placebo | |||
| ADVANCE, 2007 NCT00145925 | fixed combination of perindopril and indapamide versus placebo | patients with type 2 diabetes irrespective of initial blood pressure levels or the use of other blood pressure lowering drugs | |
| ADVANCE, 2007 NCT00145925 | low-dose fixed combination of perindopril and indapamide versus placebo | individuals with type 2 diabetes | double-blind Follow-up duration: 4.3 yrs Asia, Australasia, Europe, and North America |
| picotamide versus placebo | |||
| Cocozza, 1995 | picotamide 300 mg TID versus placebo | normotensive diabetic patients with asymptomatic mild or moderate nonstenotic (< 50%) carotid atherosclerotic lesions and negative history of cerebrovascular ischemic events | double blind Follow-up duration: 24 months Italy |
| pioglitazone versus glimepiride | |||
| PERISCOPE, 2008 NCT00225277 | pioglitazone 15 to 45 mg versus glimepiride, 1 to 4 mg | patients with coronary disease and type 2 diabetes | double blind Follow-up duration: 18 months North and South America |
| pioglitazone versus metformin | |||
| EC404, | Pioglitazone versus Metformin | patients with type 2 diabetes | Follow-up duration: 52 wk |
| pioglitazone versus placebo | |||
| PROACTIVE, NCT00174993 | oral pioglitazone titrated from 15 mg to 45 mg versus placebo | patients with type 2 diabetes who had evidence of macrovascular disease. | Follow-up duration: 34.5 months |
| IRIS, 2016 NCT00091949 | versus | ||
| PNFP-001, | Pioglitazone versus Placebo | patients with type 2 diabetes | Follow-up duration: 26 wk |
| PNFP-012, | Pioglitazone versus Placebo | patients with type 2 diabetes | Follow-up duration: 24 wk |
| PNFP-026, | Pioglitazone versus Placebo | patients with type 2 diabetes | Follow-up duration: 16 wk |
| PROactive, 2005 NCT00174993 | pioglitazone titrated from 15 mg to 45 mg versus placebo | Inadequately controlled patients with type 2 diabetes who had evidence of macrovascular disease | double blind Follow-up duration: 34.5 mo 19 European countries |
| pioglitazone versus rosiglitazone | |||
| GLAI, NCT00331487 | Pioglitazone versus Rosiglitazone | patients with type 2 diabetes and dyslipidemia | Follow-up duration: 24 wk |
| pioglitazone versus sulfonylurea | |||
| EC405, | Pioglitazone versus Sulfonylurea | patients with type 2 diabetes | Follow-up duration: 52 wk |
| OPI-501, | Pioglitazone versus Sulfonylurea | Recently diagnosed DM-2 | Follow-up duration: 56 wk |
| OPI-504, NCT00521820 | Pioglitazone versus Sulfonylurea | patients with type 2 diabetes andmild to moderate congestive heart failure | Follow-up duration: 24 wk |
| OPI-506, 0 NCT00494312 | Pioglitazone versus Sulfonylurea | Inadequately controlled DM-2 | Follow-up duration: 156 wk |
| OPI-520, NCT00521742 | Pioglitazone versus Sulfonylurea | Inadequately controlled DM-2 with mild cardiac disease(New York HeartAssociation Class I) | Follow-up duration: 52 wk |
| pioglitazone versus vildagliptin | |||
| Bolli, 2008 | vildagliptin (50 mg b.i.d. versus pioglitazone (30 mg daily | Follow-up duration: 52 weeks | |
| pioglitazone + insulin versus placebo (add on insulin) | |||
| OPI-502, | Pioglitazone + insulin versus Placebo + insulin | Insulin-dependent DM-2 | Follow-up duration: 20 wk |
| PNFP-014, | Pioglitazone insulin versus Placebo + insulin | patients with type 2 diabetes | Follow-up duration: 16 wk |
| pioglitazone + metformin versus placebo (add on MET) | |||
| PNFP-027, | Pioglitazone + metforminrea versus Placebo +metformin | patients with type 2 diabetes | Follow-up duration: 16 wk |
| pioglitazone + metformin versus sulfonylurea + metformin | |||
| EC410, | Pioglitazone + metformin versus Sulfonylurea + metformin | patients with type 2 diabetes | Follow-up duration: 104 wk |
| pioglitazone + sulfonylurea versus metformin + sulfonylurea | |||
| EC409, | Pioglitazone + sulfonylurea versus Metformin + sulfonylurea | patients with type 2 diabetes | Follow-up duration: 104 wk |
| pioglitazone + sulfonylurea versus sulfonylurea | |||
| PNFP-010, | Pioglitazone + sulfonylurea versus Sulfonylurea | patients with type 2 diabetes | Follow-up duration: 16 wk |
| prandial plus basal versus basal insulin | |||
| Hirsch A VOIR (MA), 0 | insulin lispro protamine suspension plus insulin lispro versus basal insulin glargine | metformin-treated patients with type 2 diabetes | |
| prandial premixed therapy versus basal/bolus therapy | |||
| Garber, 2006 | prandial premixed therapy versus basal/bolus therapy | ||
| prandial premixed therapy tid versus basal/bolus therapy | |||
| Rosenstock, 2008 | lispro mix 50/50: 50% insulin lispro protamine suspension and 50% lispro 3 times daily (prandial
premixed therapy) versus glargine at bedtime plus mealtime lispro (basal/bolus therapy) | ||
| pravastatin versus placebo | |||
| PROSPER diabetic (sub group), 2002 | pravastatin 40mg daily versus placebo | mena and women aged 70–82 years with a history of, or risk factors for, vascular disease | double blind Follow-up duration: 3.2y mean |
| LIPID (diabetic sub group), 1998 | pravastatin 40 mg daily versus placebo | patients with a history of myocardial infarction or hospitalization for unstable angina and initial plasma total cholesterol levels of 155 to 271 mg per deciliter | double blind Follow-up duration: mean 6.1y Australia, New Zealand |
| CARE (diabetic sub group), 1998 | pravastatin versus placebo | men and postmenopausal women between 21 to 75 years of age, with MI between 3 and 20 months before randomization and plasma total cholesterol values <240mg/dL, LDL-C levels between 115 and 174mg/dL, and triglycerides <350mg/dL | |
| WOSCOPS (diabetic sub group), 1996 | pravastatin 40 mg daily versus placebo | men aged 45-64 years with no history of myocardial infarction and plasma total cholesterol concentrations of 6.5-8.0 mmol/L at initial screening | double blind Follow-up duration: mean 4.9y |
| pravastatin versus usual care | |||
| GISSI P (diabetic sub group), 2000 | pravastatin 20 mg daily versus usual care | recent acute myocardial infarction patients (< or = 6 months) with total blood cholesterol > or = 200 mg/dl | open Follow-up duration: median 24.3 months |
| ALLHAT-LLT (diabetic sub group), 2002 | pravastatin versus usual care | Ambulatory persons aged 55 years or older, with lowdensity lipoprotein cholesterol (LDL-C) of 120 to 189 mg/dL (100 to 129 mg/dL if known CHD) and triglycerides lower than 350 mg/dL | open |
| pravastatin high dose versus pravastatin | |||
| PROVE IT TIMI 22 (diabetic sub group), 2006 | pravastatin 80mg daily versus pravastatin 40mg daily | patients hospitalized for an acute coronary syndrome within the preceding 10 days | double blind Follow-up duration: 24 months mean |
| premix aspart70/30 twice daily versus once daily insulin glargine | |||
| INITIATE (Raskin) DOUBLON, 2008 | biphasic insulin aspart 70/30 (BIAsp 70/30, prebreakfast
and presupper) versus once-daily insulin glargine | insulin-naive patients with HbA1c values 8.0% on 1,000 mg/day metformin alone or in combination with other OADs | |
| premix lispro 50/50 thrice time versus glargine once daily | |||
| Robbins, 2007 NCT00191464) | lispro mix 50/50 (50% insulin lispro protamine suspension [ILPS] and 50% lispro) TID for 24 weeks versus insulin glargine QD at bedtime | patients with type 2 diabetes mellitus and an HbA(1c) level of 6.5% to 11.0%, who were receiving metformin and/or a sulfonylurea with a stable dose of 0 to 2 daily insulin injections | open-label Follow-up duration: 24 weeks Australia, Greece, India, The Netherlands, Poland, Puerto Rico, and the United States |
| Kazda, 2006 | 3x daily lispro mid mixture (MidMix; 50% lispro, 50% protaminated lispro), versus 1x daily insulin glargine | patients with type 2 diabetes starting insulin treatment | open-label Follow-up duration: 24 week Germany |
| premix lispro 75/25 twice daily versus glargine once daily | |||
| DURABLE (Buse) DOUBLONS, 2011 | lispro mix 75/25 twice daily versus once-daily insulin glargine | type 2 diabetes patients | |
| DURABLE (Buse), 2009 NCT00279201 | twice-daily lispro mix 75/25 versus daily glargine | patients with type 2 diabetes mellitus failing to achieve control with starter insulin treatment and continuing oral antihyperglycemic drugs | Follow-up duration: 24 weeks |
| Malone, 2004 | mixture of 75% insulin lispro protamine suspensionand 25% insulin lispro (Mix 75/25) BID versus insulin glargine QD | patients with type 2 diabetes beginning insulin therapy | open-label Follow-up duration: 16 week USA |
| Malone, 2005 | insulin lispro mixture (25%insulin lispro and 75% NPL) twice daily versus once-daily insulin glargine | patients with Type 2 diabetes inadequately controlled with intermediate insulin, or insulin plus oral agent(s) combination therapy | Follow-up duration: 32 weeks |
| premix lispro thrice daily versus glargine once daily | |||
| Jacober, 2006 | intensive insulin lispro mixture therapy for 4 months versus once-daily insulin glargine | insulin-naïve patients with type 2 diabetes receiving oral antidiabetes agents | Follow-up duration: 4 months |
| premixed insulin lispro versus basal-bolus | |||
| Masuda, 2008 | twice-daily 50/50 premixed insulin lispro versus NPH insulin at bedtime and preprandial insulin lispro | insulin-naïve type 2 diabetic patients | |
| ramipril versus placebo | |||
| DREAM ramipril, 2006 NCT00095654 | ramipril up to 15 mg daily versus placebo | patients with impaired fasting glucose or impaired glucose tolerance, or both, and no previous cardiovascular disease | double blind Follow-up duration: 3 y (median) 21 countries |
| DIABHYCAR, 2004 | ramipril 1.25 mg/day versus placebo | patients with type 2 diabetes who have microalbuminuria or proteinuria | double-blind Follow-up duration: median 4 years Europe, North Africa |
| DREAM, 2008 | ramipril(up to 15 mg per day) versus placebo | people aged >=30 years, with Impaired glucose tolerance and/or impaired fasting glucose without known CVD or renal insufficiency | open Follow-up duration: 3 years |
| repaglinide versus ??? | |||
| YSRE0001, 0 NCT00336310 | Repaglinide versus NA | double-blind Follow-up duration: 12 weeks Taiwan | |
| repaglinide versus control (add on MET) | |||
| Moses, 1999 | prestudy dose of metformin with the addition of repaglinide versus prestudy dose of metformin | patients with type 2 diabetes who had inadequate glycemic control (HbA1c > 7.1%) when receiving the antidiabetic agent metformin | open Follow-up duration: 12 weeks |
| repaglinide versus glibenclamide | |||
| Landgraf, 1999 | repaglinide, administered preprandially three times daily versus glibenclamide, given preprandially once or twice daily | double-blind Follow-up duration: 14 weeks | |
| Marbury, 1999 | versus | ||
| Wolffenbuttel, 1999 | repaglinide (0.5-4 mg t.i.d.) versus glyburide (1.75-10.5 mg daily) | double-blind Follow-up duration: 1 year | |
| repaglinide versus gliclazide | |||
| AGEE-3783, 0 NCT01022762 | repaglinide (1 mg repaglinide twice daily (weeks 0-4), titrated versus gliclazide (80 mg gliclazide once daily (weeks 0-4), titrated | Chinese subjects with type 2 diabetes who never have been treated with oral anti-diabetic drugs | China |
| repaglinide versus glipizide | |||
| Madsbad, 2001 | repaglinide, 1-4 mg at mealtimes versus glipizide, 5-15 mg daily | double-blind Follow-up duration: 1 year | |
| repaglinide versus Metformin | |||
| ReMet, 0 NCT00118950 | Repaglinide versus Metformin | Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet | double-blind Denmark |
| repaglinide versus metformin | |||
| Lund, 2007 | repaglinide 2 mg thrice daily versus metformin 1 g twice daily | non-obese patients with type 2 diabetes | double-blind |
| repaglinide versus Metformin (add on insulin) | |||
| Reform, 0 NCT00118963 | Repaglinide + BIAsp30 versus Metformin + BIAsp30 | non-obese patients with type-2-diabetes, uncontrolled on diet alone | double-blind |
| repaglinide versus on top pioglitazone | |||
| Raskin, 2001 | versus | ||
| repaglinide versus on top rosiglitazone | |||
| Raskin, 2001 | versus | ||
| repaglinide versus on top troglitazone | |||
| Raskin, 2000 | repaglinide (0.5–4.0 mg at meals), versus combination of repaglinide (1–4 mg at meals) and troglitazone (200–600 mg once daily) | Patients with type 2 diabetes who had inadequate glycemic control (HbA1c 7.0%) during previous monotherapy | open Follow-up duration: 22 weeks |
| repaglinide versus placebo | |||
| Goldberg, 1998 | repaglinide versus placebo | patients with type 2 diabetes | double-blind Follow-up duration: 18 weeks |
| Jovanovic, 2000 | repaglinide 1 mg (n = 140), or repaglinide 4 mg (n = 146) versus placebo | double-blind Follow-up duration: 24 weeks | |
| Chuang, 1999 | versus | ||
| Bech, 2003 | repaglinide initiated at 0.5 mg per meal, increased to 1 mg after 4 weeks if fasting plasma glucose exceeded 7.8 mmol/l. versus placebo | pharmacotherapy-naive patients with Type 2 diabetes | double-blind Follow-up duration: 16 weeks |
| Goldberg, 1998 | repaglinide versus placebo | type 2 diabetes | double-blind |
| Jovanovic, 2000 | repaglinide 1 mg or repaglinide 4 mg versus placebo | double-blind Follow-up duration: 24 weeks | |
| repaglinide versus placebo (on top bedtime NPH-insulin) | |||
| Landin-Olsson, 1999 | versus | ||
| repaglinide + insulin versus insulin | |||
| AGEE-1524, 0 NCT00799448 | repaglinide combined with insulin NPH versus biphasic human insulin 30 alone | type 2 diabetics inadequately controlled with sulfonylurea (SU) +/ biguanide therapy | open Greece |
| AGEE-3020, | versus | ||
| repaglinide + metformin versus metformin | |||
| AGEE-1411, NCT01465152 | metformin and repaglinide versus | open Spain | |
| repaglinide + metformin versus repaglinide | |||
| AGEE-3705, 0 NCT00819741 | repaglinide plus metformin versus repaglinide alone | Chinese subjects with type 2 diabetes having an HbA1c (glycosylated haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before | open China |
| AGEE-3018, | versus | ||
| repaglinide + metformin versus rosiglitazone + metformin | |||
| Raskin , 2009 NCT00399711 | repaglinide and metformin fixed dose combination tablet given as twice daily versus twice daily rosiglitazone and metformin fixed dose combination | subjects with type 2 diabetes currently on monotherapy | open Follow-up duration: 26 weeks USA |
| repaglinide + metformin versus SU or MET | |||
| AGEE-3017, 0 NCT00568984 | combination therapy of repaglinide and metformin versus conventional treatment with a sulphonylurea or metformin in monotherapy | China | |
| rosiglitazone versus control | |||
| Wang, 2005 | rosiglitazone 4 mg/d versus control | patients with diabetes and CAD who had undergone percutaneous coronary intervention | open Follow-up duration: 6 months |
| rosiglitazone versus glipizide | |||
| APPROACH, 2008 NCT00116831 | rosiglitazone at up to 8 mg/day versus glipizide at 15 mg/day | patients with type 2 diabetes and coronary artery disease | double blind Follow-up duration: 18 months |
| rosiglitazone versus glyburide | |||
| 49653/020 , | Rosiglitazone versus Glyburide | patients with type 2 diabetes | Follow-up duration: 52 wk |
| 49653/079 , | Rosiglitazone with or without glyburide versus Glyburide | patients with type 2 diabetes poorly controlled on maximum dose of Gly | Follow-up duration: 26 wk |
| 49653/080 , | Rosiglitazone versus Glyburide | patients with type 2 diabetes | Follow-up duration: 156 wk |
| 49653/097 , | Rosiglitazone versus Glyburide | patients with type 2 diabetesDM | Follow-up duration: 156 wk |
| 49653/143 , NCT00333723 | Rosiglitazone and glyburide versus Glyburide | Type 2 DM poorly controlled on glyburide | Follow-up duration: 24 wk |
| rosiglitazone versus glyburide (add on MET) | |||
| 49653/137 , NCT00500955 | Rosiglitazone and metformin versus Glyburide and metformin | patients with type 2 diabetes | Follow-up duration: 32 wk |
| rosiglitazone versus metformin | |||
| 49653/093 , | Rosiglitazone with or without metformin versus Metformin | patients with type 2 diabetes poorly controlled on Met | Follow-up duration: 26 wk |
| 49653/094 , | Rosiglitazone and metformin versus Metformin | Type 2 DM poorly controlled on Met | Follow-up duration: 26 wk |
| rosiglitazone versus metformin/sulfonylurea | |||
| RECORD, 2013 NCT00379769 | versus | ||
| rosiglitazone versus placebo | |||
| 49653/011 , | Rosiglitazone versus Placebo | patients with type 2 diabetes | Follow-up duration: 24 wk |
| DREAM rosiglitazone, 2006 NCT00095654 | rosiglitazone 8 mg daily versus placebo | patients with impaired fasting glucose or impaired glucose tolerance, or both | double blind Follow-up duration: 3 years (median) 21 countries |
| 49653/128 , | Rosiglitazone versus Placebo | patients with type 2 diabetes on concurrent Su | Follow-up duration: 28 wk |
| 49653/134 , | Rosiglitazone versus Placebo | patients with type 2 diabetes on Gly and Met | Follow-up duration: 28 wk |
| 49653/136 , | Rosiglitazone versus Placebo | patients with type 2 diabetes and chronic renal failure on Su, insulin, or both | Follow-up duration: 26 wk |
| 49653/330 , | Rosiglitazone versus Placebo | Chronic psoriasis | Follow-up duration: 52 wk |
| 49653/331 , | Rosiglitazone versus Placebo | Chronic psoriasis | Follow-up duration: 52 wk |
| AVA100193 , | Rosiglitazone versus Placebo | Mild-to-moderate Alzheimer’s disease | Follow-up duration: 24 wk |
| BRL 49653/334 , NCT00306644 | Rosiglitazone versus Placebo | patients with type 2 diabetes or insulin resistance syndrome | Follow-up duration: 52 wk |
| rosiglitazone versus placebo (add on glicazide) | |||
| 49653/145 , | Rosiglitazone and gliclazide versus Gliclazide | patients with type 2 diabetes | Follow-up duration: 26 wk |
| rosiglitazone versus placebo (add on glimepiride) | |||
| 49653/234 , | Rosiglitazone and glimepiride versus Glimepiride | patients with type 2 diabetes | Follow-up duration: 26 wk |
| rosiglitazone versus placebo (add on glipizide) | |||
| 49653/135 , | Rosiglitazone and glipizide versus Glipizide | Elderly patients with type 2 DM | Follow-up duration: 104 wk |
| rosiglitazone versus placebo (add on glyburide) | |||
| 100684 , NCT01045590 | Rosiglitazone and glyburide versus Glyburide | Korean patients with type 2 DM | Follow-up duration: 52 wk |
| 49653/127 , | Rosiglitazone and glyburide versus Glyburide | patients with type 2 diabetespoorly controlled on Gly | Follow-up duration: 26 wk |
| 49653/162 , | Rosiglitazone and glyburide versus Glyburide | patients with type 2 diabetes | Follow-up duration: 26 wk |
| rosiglitazone versus placebo (add on insulin) | |||
| 49653/085 , | Rosiglitazone and insulin versus Insulin | patients with type 2 diabetes | Follow-up duration: 26 wk |
| 49653/095 , | Rosiglitazone and insulin versus Insulin | patients with type 2 diabetes poorly controlled on insulin | Follow-up duration: 26 wk |
| BRL 49653/347 , NCT00054782 | Rosiglitazone and insulin versus Insulin | patients with type 2 diabetes poorly controlled on insulin | Follow-up duration: 24 wk |
| rosiglitazone versus placebo (add on MET) | |||
| 49653/284 , NCT00501020 | Rosiglitazone and metformin versus Metformin | patients with type 2 diabetes | Follow-up duration: 24 wk |
| 712753/008 , NCT00241605 | Rosiglitazone and metformin versus Metformin | Type 2 DM poorly controlled on Met | Follow-up duration: 48 wk |
| SB-712753/002 , | Rosiglitazone and metformin versus Metformin | patients with type 2 diabetes poorly controlled | Follow-up duration: 24 wk |
| SB-712753/003 , | Rosiglitazone and metformin versus Metformin | Mild type 2 DM | Follow-up duration: 32 wk |
| rosiglitazone versus placebo (add on SU) | |||
| 49653/015 , | Rosiglitazone and sulfonylurea versus Sulfonylurea | patients with type 2 diabetes | Follow-up duration: 24 wk |
| 49653/125 , NCT00422955 | Rosiglitazone and sulfonylurea versus Sulfonylurea | patients with type 2 diabetes | Follow-up duration: 26 wk |
| 49653/132 , | Rosiglitazone and sulfonylurea versus Sulfonylurea | Patients in China with type 2 DM | Follow-up duration: 24 wk |
| 49653/147 , | Rosiglitazone and sufonylurea versus Sulfonylurea | Indo-Asian patients with type 2 diabetes | Follow-up duration: 26 wk |
| rosiglitazone versus standard glucose-lowering drugs | |||
| ADOPT, 2006 NCT00279045 | Rosiglitazone 4mg twice daily versus Metformin 1000mg twice daily or glyburide 7.5mg twice daily | Recently diagnosed type type 2 diabetes | double blind Follow-up duration: 4y (median) United States, Canada, Europe |
| RECORD, 2009 NCT00379769 | addition of rosiglitazone (4-8 mg daily titrated) to metformin or sulfonylurea, target HbA1c<=7·0% versus combination of metformin and sulfonylurea, target HbA1c<=7·0% | patients with type 2 diabetes onmonotherapy with either metformin or sulfonylurea andin less than optimal blood glucose control (HbA1c >7·0–9·0%) | open Follow-up duration: 5.5 y Europe, Australia |
| rosiglitazone versus usual care | |||
| 49653/211 , | Rosiglitazone and usual care versus Usual care | Type 2 DM with CHF | Follow-up duration: 52 wk |
| rosiglitazone and metformin versus placebo | |||
| CANOE, 2010 NCT00116932 | rosiglitazone (2 mg) and metformin (500 mg) twice-daily versus placebo | patients with impaired glucose tolerance | double-blind Follow-up duration: 3.9y (median) |
| saxagliptin versus glipizide | |||
| saxagliptin, | saxagliptin versus titrated glipizide plus metformin | adult patients with type 2 diabetes and inadequate glycemic control | double-blind Follow-up duration: 52 weeks |
| saxagliptin versus placebo | |||
| SAVOR TIMI, 2013 NCT01107886 | saxagliptin versus placebo | patients with type 2 diabetes who had a history of, or were at risk for, cardiovascular events | double-blind Follow-up duration: 2.1 years (median) |
| SAVOR-TIMI 53, 2013 NCT01107886 | Saxagliptin 5 mg or 2.5 mg once daily
versus Placebo | Patients With Type 2 Diabetes | USA |
| saxagliptin versus placebo (add on current treatment) | |||
| saxgliptin, renal study, | saxagliptin versus placebo added to patients’ current diabetes treatment | patients with moderate to severe renal impairment or end-stage renal disease | Follow-up duration: 12 weeks |
| saxagliptin versus placebo (add on insulin) | |||
| CV181-057, NCT00757588 | Saxagliptin, 5 mg versus placebo (on top insulin) | Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin | |
| saxagliptin versus placebo (add on MET) | |||
| CV181-066, NCT00683657 | Saxagliptin versus placebo | Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet And Exercise And A Stable Dose Of Metformin ¡Ý1500 mg/Day | |
| CV181-080, NCT00885378 | 2.5 mg Saxagliptin, Twice Daily versus placebo | Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin IR Alone | |
| DeFronzo, 2009 NCT00121667 | saxagliptin (2.5, 5, or 10 mg once daily) versus placebo | Patients With Inadequately Controlled Type 2 Diabetes With Metformin Alone | Follow-up duration: 24 weeks |
| Jadzinsky, 2009 NCT00327015 | saxagliptin versus placebo | treatment-naïve patients with type 2 diabetes (T2D) and inadequate glycaemic control | |
| saxagliptin versus placebo (add on TZD) | |||
| Hollander, NCT00295633 | saxagliptin (2.5 or 5 mg) versus placebo | patients with type 2 diabetes and inadequate control on thiazolidinedione alone | |
| saxagliptin versus placebo (monotherapy) | |||
| CV181-011, NCT00121641 | oral saxagliptin 2.5, 5, or 10 mg once daily versus placebo | Follow-up duration: 24 weeks | |
| CV181-038, NCT00316082 | Saxagliptin monotherapy versus placebo | type 2 diabetic subjects who are not controlled with diet and exercise | |
| CV181-041, NCT00374907 | Saxagliptin versus placebo | Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise | |
| Rosenstock, 2008 NCT00950599 | saxagliptin 2.5, 5, 10, 20 or 40 mg once daily versus placebo | drug-naive patients with T2DM and inadequate glycaemic control | Follow-up duration: 12 weeks |
| saxagliptin versus sitagliptin (add on MET) | |||
| saxagliptin vs sitagliptin, | saxagliptin 5 mg once daily add on metformin versus sitagliptin 100 mg onece daily add on metformin | adults with type 2 diabetes who did not attain adequate glycemic control on metformin therapy alone | Follow-up duration: 18 weeks |
| saxagliptin + glyburide versus glyburide uptitration | |||
| CV181-040, NCT00313313 | saxagliptin added to a submaximal sulphonylurea dose versus uptitration of sulphonylurea monotherapy | patients with type 2 diabetes and inadequate glycaemic control with sulphonylurea monotherapy | Follow-up duration: 24 weeks |
| saxagliptin plus metformin XR 1500mg versus metformin up to 2000mg | |||
| CV181-085, NCT00918138 | Saxagliptin in Combination With Metformin XR 1500 mg versus Up-titrated Metformin XR to 2000 mg | Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise and a Stable Dose of Metformin XR 1500 mg | |
| screening for CAD versus no screening | |||
| DIAD, 2009 NCT00769275 | screening with adenosine-stress radionuclide myocardial perfusion imaging (MPI) versus no screening | participants with type 2 diabetes and no symptoms of CAD | open Follow-up duration: 4.8 years USA, Canada |
| DYNAMIT, 2010 NCT00627783 | screening for silent ischemia using a bicycle exercise test or Dipyridamole Single Photon Emission Computed Tomography versus no screening | diabetic patients with no evidence of coronary artery disease and at least 2 additional cardiovascular risk factors | open France |
| semaglutide versus placebo | |||
| SUSTAIN 6, 2016 NCT01720446 | once-weekly semaglutide (0.5 mg or 1.0 mg) versus placebo | patients with type 2 diabetes who were on a standardcare regimen | double-blind Follow-up duration: 2.1 y (median) 20 countries |
| simvastatin versus placebo | |||
| HPS (diabetic sub group), 2002 | simvastatin 40mg daily versus placebo | Men and women diabetes aged about 40–80 years with non-fasting blood total cholesterol concentrations of at least 3·5 mmol/L (135 mg/dL) | double blind |
| 4S (diabetic sub group), 1999 | simvastatin versus placebo | diabetic men and women aged 35 to 70 years with previous MI or active, stable angina pectoris and with serum total cholesterol level between 5.5 to 8.0 mmol/L and serum triglyceride level <=2.5 mmol/L | double blind Follow-up duration: 5.4y Denmark, Finland, Iceland, Norway, and Sweden |
| sitagliptin versus control (add on MET) | |||
| Reasner, 2011 NCT00482729) | sitagliptin/metformin 50/500 mg bid uptitrated over 4 weeks to achieve maximum doses of sitagliptin/metformin 50/1000 mg bid versus metformin monotherapy | drug-naive patients with type 2 diabetes | NA |
| sitagliptin versus glimepiride (add on MET) | |||
| Arechavaleta, 2011 NCT00701090 | sitagliptin 100 mg daily versus glimepiride (starting dose 1 mg/day and up-titrated, based upon patient's self-monitoring of blood glucose results, to a maximum dose of up to 6 mg/day) | patients with type 2 diabetes inadequately controlled on metformin monotherapy | double-blind Follow-up duration: 30 weeks |
| sitagliptin versus metformin | |||
| Goldstein (sit vs met), 2007 | sitagliptin 100 dailyily versus metformin 1000 mg or 2000 mg daily;imag | ||
| Goldstein (sit+met vs met), 2007 | sitagliptin 50 mg daily plus metformin 1000 or 2000 mg dailyç$4 versus metformin 1000 or 2000 mg daily | ||
| sitagliptin versus pioglitazone | |||
| Pérez-Monteverde, 2011 NCT00541450 | sitagliptin100 mg qd versus pioglitazone 15 mg qd, up-titrated to 30 mg after 6 weeks | drug-naïve patients with type 2 diabetes | double-blind Follow-up duration: 12 weeks |
| sitagliptin versus placebo | |||
| Goldstein, 2007 NCT00103857 | sitagliptin 100 mg daily versus placebo | ||
| Hanefeld, 2007 | sitagliptin 25 mg or 50 mg or 100 mg dailyi versus placebo | ||
| TECOS, 2015 NCT00790205 | sitagliptin phosphate, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily versus placebo | patients with Type 2 Diabetes Mellitus having a history of cardiovascular disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0% | double-blind Follow-up duration: 3.0 years (median) 38 countries |
| sitagliptin versus placebo (add on insulin+/-MET) | |||
| Vilsbøll, 2010 NCT00395343 | once-daily sitagliptin 100 mg versus placebo | patients with type 2 diabetes inadequately controlled on long-acting, intermediate-acting or premixed insulin | double-blind |
| sitagliptin versus placebo (add on MET) | |||
| Charbonnel, 2006 NCT0086515 | sitagliptin 100 mg daily (add-on to metformin therapy)j versus placebo (add-on tometformin therapy); | ||
| Nauck, 2007 NCT00094770 | sitagliptin 100 mg daily (add-on to metformin therapy)j versus placebo (add-on to metformin therapy); | ||
| raz, 2008 NCT00337610 | sitagliptin 100 mg once daily versus placebo | patients with type 2 diabetes | |
| Scott** (sit vs pbo on top met), 2007 | sitagliptin 100 mg daily (add-on to metformin therapy)j versus placebo (add-on to metformin therapy). | patients with type 2 diabetes who were inadequately on mET monotherapy | |
| sitagliptin versus placebo (add on PIO) | |||
| Rosenstock , 2006 NCT00086502 | sitagliptin 100 mg once daily versus placebo | patients with type 2 diabetes and inadequate glycemic control | double-blind Follow-up duration: 24 weeks |
| sitagliptin versus placebo (on top PIO) | |||
| Rosenstock (sit on top pio vs pbo), 2006 NCT00086502 | sitagliptin 100 mg daily (add-on to pioglitazone therapy)sl˜ðõØ versus placebo (add-on to pioglitazone therapy); | ||
| sitagliptin versus placebo (on-top glimepiride+/- metformine) | |||
| Hermansen, 2007 | sitagliptin 100 mg daily (add-on to ongoing stable doses of glimepiride, alone or in combination with metformin)ocumen versus placebo (add-on to ongoing stable doses of glimepiride, alone or in combination with metformin); | ||
| sitagliptin versus rosiglitazone (add on MET) | |||
| Rigby , 2010 | sitagliptin phosphate, 100 mg daily versus rosiglitazone maleate, 4 mg daily | type 2 diabetes mellitus inadequately controlled by metformin monotherapy | open Follow-up duration: 16 weeks |
| sitagliptin versus Sulphonylurea (on top MET) | |||
| Al Sifri, 2011 | sitagliptin 100 mg qd versus prestudy sulphonylurea | Muslim patients with type 2 diabetes who were treated with a stable dose of a sulphonylurea with or without metformin for at least 3 months | open |
| sitagliptin 50mg bid monotherapy versus glipizide | |||
| Scott* (sit vs glipi), 2007 | sitagliptin 50mg bid versus glipizide 5mg to 20 mg dailyitm | patients with type 2 diabetes who have inadequate glycaemic control on diet and exercise | double-blind Follow-up duration: 12 weeks |
| sitagliptin 50mg bid monotherapy versus placebo | |||
| Scott* (sit vs pbo), 2007 | sitagliptin 50 mg b.i.d versus placebo | ||
| sitagliptin monotherapy versus metformin | |||
| Aschner, 2010 NCT00449930 | once-daily sitagliptin 100 mg versus twice-daily metformin 1000 mg | treatment-naïve patients with type 2 diabetes | double-blind Follow-up duration: 24 weeks |
| sitagliptin monotherapy versus placebo | |||
| Aschner, 2006 NCT00087516 | sitagliptin 100 or 200 mg dailym versus placebo | patients with type 2 diabetes | Follow-up duration: 24 weeks |
| Barzilai, 2011 NCT00305604 | once-daily sitagliptin (100 or 50 mg, depending on renal function) versus placebo | elderly patients with type 2 diabetes | double-blind Follow-up duration: 24 weeks US |
| Chan, 2008 | sitagliptin versus placebo | patients with type 2 diabetes and chronic renal insufficiency | double-blind Follow-up duration: 12 weeks |
| Mohan , 2009 | sitagliptin 100mg once daily monotherapy versus placebo | Chinese, Indian, and Korean patients with type 2 diabetes inadequately controlled by diet and exercise. | double-blind Follow-up duration: 18 weeks |
| Nonaka, 2008 NCT00371007 | sitagliptin 100 mg daily monotherapy versus placebo | Japanese patients with type 2 diabetes | double-blind |
| Raz, 2006 | sitagliptin 100 mg (or 200 mg) daily versus placebo | patients with type 2 diabetes mellitus and inadequate glycaemic control | |
| sitagliptin monotherapy versus voglibose | |||
| Iwamoto , 2010 | sitagliptin 50 mg once daily monotherapy versus voglibose 0.2 mg thrice daily before meals | Japanese patients with type 2 diabetes | double-blind Follow-up duration: 12 weeks |
| sitagliptin+pio versus metformin+pio | |||
| Derosa , 2010 | pioglitazone 30 mg plus sitagliptin 100 mg once a day versus pioglitazone 15 mg plus metformin 850 mg twice a day | poorly controlled type 2 diabetes mellitus patients | |
| SU versus rosiglitazone (add on MET) | |||
| Hamann, 2008 | combination sulphonylurea plus metformin versus rosiglitazone/metformin fixed-dose combination | overweight individuals with inadequately controlled type 2 diabetes mellitus.Individuals with inadequate glycaemic control (HbA (1c)> or =7%) while on metformin monotherapy (> or =0.85 g/day) | Follow-up duration: 52 weeks |
| sulfinyrazone versus placebo | |||
| Dutch, 1980 | sulfinyrazone versus | Follow-up duration: 32 months | |
| taspoglutide versus placebo (add on MET) | |||
| Ratner (20mg once weekly), 2010 NCT00460941 | taspoglutide s.c. 20mg once weekly for 8 weeks versus placebo s.c. once weekly on top metformin | subjects with Type 2 diabetes inadequately controlled on metformin alone | double-blind Follow-up duration: 8 weeks (+4wk) Australia, France, Germany, Mexico, Peru, USA |
| taspoglutide 10mg once weekly versus placebo | |||
| Nauck 10 once weekly vs PBO, 2009 NCT00423501 | taspoglutide, either 5, 10, or 20 mg once weekly or 10 or 20 mg once every 2 weeks for 8 weeks versus placebo | patients with type 2 diabetes inadequately controlled with metformin | double-blind Follow-up duration: 12 weeks |
| taspoglutide 20mg once every 2 weeks versus placebo | |||
| Nauck 20 every 2 weeks vs PBO, 2009 | versus | ||
| taspoglutide 20mg once weekly versus placebo | |||
| Nauck 20 once weekly vs PBO, 2009 | versus | ||
| telmisartan versus placebo | |||
| PROFESS, 2008 | 80 mg telmisartan once daily versus placebo | double-blind Follow-up duration: 2.4y | |
| temisartan versus enalapril | |||
| DETAIL, 2004 | telmisartan 80 mg daily versus enalapril 20 mg daily | subjects with type 2 diabetes and early nephropathy | double-blind Follow-up duration: 5 years northern Europe |
| ticlopidine versus placebo | |||
| Birmingham-A, 1979 | ticlopidine 100, 250, 500 mg versus | Follow-up duration: 2 months | |
| London diabetes, 1983 | ticlopidine 500mg versus | Follow-up duration: 12 months | |
| TIMAD, 1984 | ticlopidine 500mg versus | Follow-up duration: 32m | |
| BTRS, 1992 | ticlopidine 500mg/d versus placebo | insulin-treated diabetics with background retinopathy | double blind Follow-up duration: 48 months |
| Nyberg, 1984 | ticlopidine 500mg daily versus placebo | insulin dependent diabetes complicated by nephropathy | double blind Follow-up duration: 12 months |
| troglitazone versus placebo | |||
| TRIPOD (Buchanan), 2002 | troglitazone 400 mg once daily versus placebo | Hispanic women with previous gestational diabetes | double blind Follow-up duration: 30 months (median) USA |
| US DDP troglitazone (Knowler), 2005 | troglitazone versus double placebo | nondiabetic patients with elevated glucose and high risk for diabetes | double blind Follow-up duration: 0.9 year USA |
| valsartan versus amlodipine | |||
| NAGOYA HEART, 2011 NCT00129233 | blood-pressure-lowering therapy based on valsartan; blood-pressure goal of <130/80 mm Hg versus blood-pressure-lowering therapy based on amlodipine; blood-pressure goal of <130/80 mm Hg | patients with hypertension with type 2 diabetes or impaired glucose tolerance | open Follow-up duration: 3.2 y median Japan |
| valsartan versus placebo | |||
| NAVIGATOR valsartan, 2010 NCT00097786 | valsartan up to 160 mg daily versus placebo | subjects with impaired glucose tolerance and either CV disease or CV risk factors | double-blind Follow-up duration: 5 years 40 countries |
| verapamil versus control | |||
| INVEST (subgroup), 2003 | calcium antagonist strategy (verapamil sustained release) versus non-calcium antagonist strategy (atenolol) | hypertensive CAD patients aged 50 years or older | open Follow-up duration: 24 months 14 countries |
| vildagliptin versus gliclazide (add on MET) | |||
| Filozof, 2009 NCT00102466 | vildagliptin (50 mg twice daily versus gliclazide (up to 320 mg/day | patients with Type 2 diabetes inadequately controlled with metformin | double-blind Follow-up duration: 52 weeks |
| vildagliptin versus glimepiride (add on MET) | |||
| Matthews , 2010 | vildagliptin versus glimepiride | patients with type 2 diabetes mellitus inadequately controlled (HbA1c 6.5-8.5%) by metformin monotherapy | double-blind Follow-up duration: 2 years |
| vildagliptin versus metformin | |||
| Goke, 2008 | vildagliptin (100 mg daily) versus metformin (2 000 mg daily). | drug-naïve patients with type 2 diabetes | |
| Schweizer, 2007 NCT00099866 | vildagliptin 100mg versus metformin up to 2000 mg daily | drug-naïve patients with Type 2 diabetes | Follow-up duration: 52 weeks |
| Schweizer, 2009 NCT00246619 | vildagliptin (100 mg daily versus metformin (titrated to 1500 mg daily | drug-naïve patients with type 2 diabetes aged>or=65 years | |
| vildagliptin versus pioglitazone (add on MET) | |||
| Bolli, 2008 NCT00237237 | vildagliptin 100 mg daily (add-on to metformin therapy) versus pioglitazone 30 mg daily (add-on to metformin therapy)j | patients with type 2 diabetes inadequately controlled with metformin monotherapy | double-blind |
| vildagliptin versus placebo | |||
| Mimori, 2006 | vildagliptin 20 mg or 50 mg or 100 mg daily versus placebo | ||
| NCT00351832, NCT00351832 | vildagliptin 50mg qd, 50mg bid or 100mg qd versus placebo | Patients With Type 2 Diabetes | Follow-up duration: 12 weeks Japan |
| Rosenstock, 2008 NCT00237250 | vildagliptin (50 mg q.d.) versus placebo | subjects with impaired glucose tolerance | double-blind Follow-up duration: 12 weeks |
| Scherbaum [2], 2008 NCT00101712 | vildagliptin 50 mg qd versus placebo | drug-naïve patients with type 2 diabetes and mild hyperglycaemia | double-blind Follow-up duration: 52 weeks |
| vildagliptin versus placebo (add on current therapy) | |||
| Lukashevich , 2011 NA | vildagliptin (50 mg qd) versus placebo | patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal impairment | Follow-up duration: 24 weeks |
| vildagliptin versus placebo (add on glimepiride) | |||
| Kikuchi, 2010 NCT00325117 | vildagliptin 50mg twice-daily versus placebo | Japanese patients with Type 2 diabetes mellitus | double-blind Follow-up duration: 12 weeks Japan |
| vildagliptin versus placebo (add on insulin) | |||
| Fonseca, 2007 NCT00099931 | vildagliptin 100 mg daily (add-on to insulin therapy)y) versus placebo (add-on to insulin therapy)y)mag | type 2 diabetes that was inadequately controlled by insulin | double-blind Follow-up duration: 24 weeks |
| Fonseca , 2008 | vildagliptin added to insulin versus | ||
| vildagliptin versus placebo (add on MET) | |||
| Ahren, 2004 | vildagliptin 50 mg daily (add-on to metformin therapy)j versus placebo (add-on to metformin therapy)mag | patients with type 2 diabetes | double-blind Follow-up duration: 12 weeks |
| Bosi, 2007 NCT00099892 | vildagliptin (50 or) 100 mg daily (add-on to metformin therapy)m versus placebo (add-on to metformin therapy)mag | patients with type 2 diabetes inadequately controlled with metformin | double-blind |
| Bosi, 2009 NCT00382096 | vildagliptin plus high-dose metformin combination therapy (50 mg + 1000 mg twice daily), versus high-dose metformin monotherapy (1000 mg twice daily). | treatment-naive patients with type 2 diabetes mellitus | Follow-up duration: 24 weeks |
| Goodman, 2009 | ildagliptin 100 mg given in the morning, vildagliptin 100 mg given in the evening versus placebo | patients inadequately controlled with metformin | double-blind Follow-up duration: 24 weeks |
| NCT00396071, NCT00396071 | vildagliptin versus placebo | Patients With Type 2 Diabetes Treated With Metformin | |
| NCT00494884 (Wollmer), NCT00494884 | Vildagliptin 100 mg o.d. versus placebo | Patients With Type 2 Diabetes Inadequately Controlled With Metformin | |
| NCT00728351, NCT00728351 | Vildagliptin and Metformin (25/1000 mg Bid) versus Metformin Monotherapy (1000 mg Bid) | Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy | |
| NCT00822211, NCT00822211 | Vildagliptin 50 mg Bid or qd versus placebo | Chinese Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy | Follow-up duration: 24 weeks |
| vildagliptin versus placebo (add on SU) | |||
| Garber, 2008 NCT00099944 | vildagliptin (50 mg given once or twice daily) versus placebo | patients with type 2 diabetes inadequately controlled with a sulphonylurea | double-blind Follow-up duration: 24 weeks |
| vildagliptin versus placebo (add on TZD) | |||
| Rosenstock** (vilda + pio vs pio), 2007 NCT00101803 | vildagliptin 50 mg or 100 mg daily plus 15 mg or 30 mg pioglitazone dailyi versus pioglitazone 30 mg daily | drug-naive patients with type 2 diabetes | double-blind Follow-up duration: 24 weeks |
| vildagliptin versus placebo (on top pioglitazone) | |||
| Garber, 2007 NCT00099853 | vildagliptin 50 or 100 mg daily (add-on to pioglitazone therapy) versus placebo (add-on to pioglitazone therapy) | ||
| vildagliptin versus rosiglitazone | |||
| Rosenstock, 2009 NCT00138619 | vildagliptin (50 mg b.i.d versus rosiglitazone (8 mg q.d., | drug-naïve type 2 diabetes mellitus patients | double-blind |
| Rosenstock* (vilda vs rosi), 2007 NCT00099918 | vildagliptin 100 mg daily daily versus rosiglitazone 8 mg once daily | drug-naïve patients with type 2 diabetes | double-blind Follow-up duration: 24 weeks |
| vildagliptin versus Sulfonylurea (add on to MET) | |||
| Ferrannini, 2009 NCT00106340 | vildagliptin 50 mg twice daily versus glimepiride titrated up to 6 mg/day | Patients inadequately controlled on metformin monotherapy (HbA(1c) 6.5-8.5%) | double-blind Follow-up duration: 52 weeks |
| vildagliptin versus TZD (add on MET) | |||
| GALIANT (Blonde), 2009 NCT00396227 | vildagliptin 100 mg versus TZD (agent and dose at the investigators' discretion | patients inadequately controlled [haemoglobin A(1C) (HbA(1c)): 7-10%] on a stable dose of metformin (> or =1000 mg/day). | |
| vildagliptin versus voglibose | |||
| Iwamoto, 2010 NA | vildagliptin (50 mg bid, versus voglibose (0.2 mg tid | Japanese patients with T2D who were inadequately controlled with diet and exercise | double-blind Follow-up duration: 12 weeks Japan |
| NCT00368134, NCT00368134 | Vildagliptin 50 mg Bid versus Voglibose 0.2 mg Tid | patients with type 2 diabetes | Follow-up duration: 12 weeks Japan |
| vildagliptin + MET versus MET | |||
| CLAF237A 23104, NCT00396357 | versus | ||
| vildagliptin monotherapy versus acarbose | |||
| Pan, 2008 NCT00110240 | vildagliptin (100 mg daily, given as 50 mg twice daily versus acarbose (up to 300 mg daily, given as three equally divided doses | drug-naive patients with Type 2 diabetes | double-blind Follow-up duration: 24 weeks |
| vildagliptin monotherapy versus gliclazide | |||
| Foley, 2009 NCT00102388 | monotherapy with vildagliptin 50 mg bid versus gliclazide up to 320 mg/day | drug-naïve patients with type 2 diabetes | double-blind Follow-up duration: 2 years |
| vildagliptin monotherapy versus pioglitazone | |||
| Rosenstock** (vilda vs pio), 2007 NCT00101803 | vildagliptin 100 mg daily daily versus pioglitazone 30 mg dailyaily | drug-naive patients with type 2 diabetes | double-blind |
| vildagliptin monotherapy versus placebo | |||
| Ahren, 2009 NCT00390520 | vildagliptin (100 mg/d) versus placebo | drug-naive patients with type 2 diabetes | |
| Dejager [1], 2007 NCT00099905 | vildagliptin 50 mg or 100 mg daily versus placebo | drug-naïve patients with type 2 diabetes | double-blind Follow-up duration: 24 weeks |
| Foley, 2011 NCT00260156 | vildagliptin 100 mg versus placebo | drug-naive patients with type 2 diabetes and mild hyperglycaemia | |
| Kikuchi, 2009 | vildagliptin 50mg bid versus placebo | Japanese patients with type 2 diabetes mellitus | Japan |
| Pi-Sunyer, 2007 NCT00120536 | vildagliptin 50 mg or 100 mg daily, imag versus placebo | drug-naïve patients with type 2 diabetes | double-blind Follow-up duration: 24 weeks |
| Pratley, 2006 | vildagliptin 25mg bid versus placebo | double-blind | |
| Ristic, 2005 | vildagliptin 25mg or 50mg or 100mg daily versus placebo | ||
| voglibose versus placebo | |||
| Voglibose Ph-3, 2009 UMIN 000001109- | voglibose 0.2 mg three times daily versus placebo | patients with impaired fasting glucose | double blind Follow-up duration: 4.01 years Japan |
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