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See also:

  • All test diab�te 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 diab�te 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, D�ring 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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