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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
  •  

    LEAD-4 study, 0

    [NCT00333151] download pdf: liraglutide | insulin secretagogues peptides (incretins) for diabetes

    Treatments

    Studied treatment Liraglutide 1.2–1.8 mg daily
    Control treatment Placebo on-top of thiazolidinediones+metformin
    Concomittant treatment TZD+/-metformin

    Patients

    Baseline characteristics
    Age (year) 55  
    Duration of diabetes (year) 9.2 y 
    HbA1c (%) 8.5 
    BMI 33.5 
    Add-on to TZD+/-Met 

    Method and design

    Randomized effectives 356 / 177 (studied vs. control)
    Blinding not reported
    Follow-up duration 26 weeks


    Results

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

    severe hypoglycemia

    0 / 356
    0 / 177
    classic 0,50 [0,00;126,72]
    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 / 356 (0,1%) 0 / 177 (0,3%) 0,50 [0,01;24,95] 12053
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:
  • 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

  • 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 # NCT00333151
    • Zinman B, Gerich J, Buse JB, Lewin A, Schwartz S, Raskin P, Hale PM, Zdravkovic M, Blonde L, , . Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD).. Diabetes Care 2009;32:1224-30. - 10.2337/dc08-2124
      Pubmed | Hubmed | Fulltext

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