VADT, 2008 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of intensive glycemic control versus conventional treatment in military veterans who had a suboptimal response to therapy for type 2 diabetes

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NCT00032487    N Engl J Med 2008 Dec 17;:
 



Studied treatment intensive glucose control
maximum dose of metformin, with either rosiglitazone (BMI >27) or glimepiride and rosiglitazone (BMI <27), insulin added if HbA1c remained >6%
Control treatment standard glucose control
Age (year) 60.4y
female (%) 3%
Weight (kg) 214 lb
Hb A1c at study end 6.9%/8.4%
Intensive glucose control target HbA1c <6%
Conventional glucose control target HbA1c <9%



Patients military veterans who had a suboptimal response to therapy for type 2 diabetes
Group sizes892 / 899
Inclusion criteriainadequate response to maximal doses of an oral agent or insulin therapy
Exclusion criteriaglycated hemoglobin level <=7.5%; a cardiovascular event during the previous 6 months; advanced congestive heart failure; severe angina; life expectancy <7 years; a body-mass index > 40; serum creatinine level of more than 1.6 mg per deciliter; alanine aminotransferase level of more than 3 times the ULN
Previous cardiovascular event (%) 40%
Waist circumference (cm)



Blindness open Inclusion period dec 2000 - may 2003
Follow-up duration 5.6y Centers 20
Lost to FU geographical localisation US
Primary endpoint MI, stroke, CV death, congestive HF, surgery for vascular disease, coronary disease, amputation Design Parallel groups
PeriodeInclusiondec 2000 - may 2003
HypotheseSuperiority
duration of diabetes (yr) 11.5y
Glycated hemoglobin (%) 9.4%
Fasting serum glucose (mg/dl)
type of diabetes type 2 diabetes mellitus



EndpointX1N1X0N0TE95% CI cardiovascular events 235 892 264 899 0,90[0,73; 1,10] cardiovascular deaths 38 892 29 899 1,32[0,81; 2,16] coronary events - 892 - 899 no data fatal and non fatal MI - 892 - 899 no data fatal MI 13 892 12 899 1,09[0,50; 2,41] fatal and non fatal stroke 28 892 36 899 0,78[0,47; 1,30] All cause death 102 892 95 899 1,08[0,80; 1,46] non fatal MI 64 892 78 899 0,83[0,59; 1,17] non fatal stroke - 892 - 899 no data major macrovascular events 235 892 264 899 0,90[0,73; 1,10] major microvascular events - 892 - 899 no data major macrovascular or microvascular events - 892 - 899 no data sudden death 11 892 4 899 Out of scale2,77[0,88; 8,74] CV events including PAD - 892 - 899 no data cardiac event - 892 - 899 no data fatal stroke 6 892 4 899 1,51[0,43; 5,38] long term deaths - 892 - 899 no data long term CV events - 892 - 899 no data New or worsening retinopathy - 892 - 899 no data Vision deterioration or vision loss - 892 - 899 no data photocoagulation 119 769 121 772 0,99[0,75; 1,30] New or worsening nephropathy - 892 - 899 no data renal impairment (or doubling creatinine) 78 882 78 884 1,00[0,72; 1,39] microalbuminuria 30 728 48 731 0,63[0,39; 1,00] new or worsening neuropathy 202 464 218 498 0,99[0,77; 1,28] Peripheral vascular events 11 892 17 899 0,65[0,30; 1,40] cerebrovascular events 28 892 36 899 0,78[0,47; 1,30] fatla or non fatal congestive HF 76 892 82 899 0,93[0,67; 1,30] fatal HF 8 892 9 899 0,90[0,34; 2,33] death by cancer 24 892 21 899 1,15[0,64; 2,08] non cardiovascular death 62 892 62 899 1,01[0,70; 1,45] MI, stroke, cardiovascular death - 892 - 899 no data severe hypoglycemia 76 892 28 899 Out of scale2,74[1,76; 4,26]0,22,01,0

Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, Zieve FJ, Marks J, Davis SN, Hayward R, Warren SR, Goldman S, McCarren M, Vitek ME, Henderson WG, Huang GD Glucose Control and Vascular Complications in Veterans with Type 2 Diabetes. N Engl J Med 2008 Dec 17;:     [PMID: 19092145]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT00032487



Registering number NCT00032487 (see trial on clinicaltrials.gov)
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All trials of intensive glycemic control

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