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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-2 (Nauck) (vs placebo) study, 2009

    [NCT00318461] 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 Metformin
    Concomittant treatment Metformin

    Patients

    Patients subjects previously treated with oral antidiabetes therapy
    Baseline characteristics
    Age (year) 57  
    Duration of diabetes (year) 7.9 y 
    HbA1c (%) 8.4 
    BMI 31.0 
    Add-on to Metformin 

    Method and design

    Randomized effectives 724 / 121 (studied vs. control)
    Blinding double blind
    Follow-up duration 26 weeks


    Results

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

    severe hypoglycemia

    0 / 724
         0 / 121
         classic 0,17 [0,00;42,58]

    vomiting

    44 / 724
         1 / 121
         classic 7,35 [1,02;52,88]

    All cause death

    0 / 724
         0 / 121
         classic 0,17 [0,00;42,58]

    all hypoglycemia

    22 / 724
         4 / 121
         classic 0,92 [0,32;2,62]

    nausea

    290 / 724
         21 / 121
         classic 2,31 [1,55;3,44]

    diarrhoea

    88 / 724
         4 / 121
         classic 3,68 [1,38;9,83]     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 / 724 (0,1%) 0 / 121 (0,4%) 0,17 [0,00;8,38] 12053
    vomiting 44 / 724 (6,1%) 1 / 121 (0,8%) 7,35 [1,02;52,88] 12053
    all hypoglycemia 22 / 724 (3,0%) 4 / 121 (3,3%) 0,92 [0,32;2,62] 12053
    nausea 290 / 724 (40,1%) 21 / 121 (17,4%) 2,31 [1,55;3,44] 0
    diarrhoea 88 / 724 (12,2%) 4 / 121 (3,3%) 3,68 [1,38;9,83] 12053
    All cause death 0 / 724 (0,1%) 0 / 121 (0,4%) 0,17 [0,00;8,38] 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.
    vomiting 6,08% 8,26‰ 5,3%
    all hypoglycemia 3,04% 3,31% -2,7‰
    nausea 40,06% 17,36% 22,7%
    diarrhoea 12,15% 3,31% 8,8%

    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 # NCT00318461
    • Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, Düring M, Matthews DR. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study.. Diabetes Care 2009;32:84-90 - 10.2337/dc08-1355
      Pubmed | Hubmed | Fulltext
    • Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone.. Cardiovasc Diabetol 2009;8:12 - 10.1186/1475-2840-8-12
      Pubmed | Hubmed | Fulltext
    • Nauck M, Marre M. Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits.. Postgrad Med 2009;121:5-15 - 10.3810/pgm.2009.05.1997
      Pubmed | Hubmed | Fulltext

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