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See also:

  • All test diabète clinical trials
  • All diabetes clinical trials
  • All type 2 diabetes - sanofi clinical trials
  • All clinical trials of insulin secretagogues peptides (incretins)
  • All clinical trials of liraglutide
    		•  

    Seino study, 2008

    [NCT00154414] download pdf: liraglutide | insulin secretagogues peptides (incretins) for diabetes

    Treatments

    Studied treatment Liraglutide 0.1–0.9 mg daily
    Control treatment Placebo
    Concomittant treatment None

    Patients

    Patients Japanese subjects with type 2 diabetes
    Inclusion criteria 1) Subjects diagnosed with type 2 diabetes and treated with diet therapy with or without single oral drug therapy; 2) 7.0 % = HbA1c < 10.0 %; 3) Body Mass Index (BMI) < 30.0 kg/m2;
    Exclusion criteria 1) Subjects treated with thiazolidinediones or insulin; 2) Subjects with any serious medical conditions;
    Baseline characteristics
    Age (year) 57 
    Duration of diabetes (year) 8.0 y 
    HbA1c (%) 8.3 
    BMI 23.9 
    Add-on to None 

    Method and design

    Randomized effectives 180 / 46 (studied vs. control)
    Blinding double blind
    Follow-up duration 14 weeks
    Geographic area Japan
    Primary endpoint HbA1c
    Remarks

    Remarks / Comments



    Results

    Endpoint Studied treat.
    n/N     Control treat.
    n/N     Graph RR [95% CI]

    severe hypoglycemia

    0 / 180
         0 / 46
         classic 0,26 [0,00;64,71]

    All cause death

    0 / 180
         0 / 46
         classic 0,26 [0,00;64,71]

    all hypoglycemia

    0 / 180
         0 / 46
         classic 0,26 [0,00;64,71]

    cardiovascular events

    0 / 180
         0 / 46
         classic 0,26 [0,00;64,71]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    severe hypoglycemia 0 / 180 (0,3%) 0 / 46 (1,1%) 0,26 [0,01;12,71] 12053
    cardiovascular events 0 / 180 (0,3%) 0 / 46 (1,1%) 0,26 [0,01;12,71] 12053
    all hypoglycemia 0 / 180 (0,3%) 0 / 46 (1,1%) 0,26 [0,01;12,71] 12053
    All cause death 0 / 180 (0,3%) 0 / 46 (1,1%) 0,26 [0,01;12,71] 12053
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 12053: Monami M, Marchionni N, Mannucci EGlucagon-like peptide-1 receptor agonists in type 2 diabetes: a meta-analysis of randomized clinical trials.Eur J Endocrinol 2009;160:909-17
  • 0:

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.

    Meta-analysis of all similar trials:

    antidiabetic drugs in test diabète for type 2 daibetes (NIDD)

    insulin secretagogues peptides (incretins) in diabetes for all type of patients

    insulin secretagogues peptides (incretins) in type 2 diabetes - sanofi for all type of patients



    Reference(s)

    Trials register # NCT00154414
    • Seino Y, Rasmussen MF, Zdravkovic M, Kaku K. Dose-dependent improvement in glycemia with once-daily liraglutide without hypoglycemia or weight gain: A double-blind, randomized, controlled trial in Japanese patients with type 2 diabetes.. Diabetes Res Clin Pract 2008;81:161-8 - 10.1016/j.diabres.2008.03.018
      Pubmed | Hubmed | Fulltext

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