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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-3 mono (Garber) study, 2009

    [NCT00294723] download pdf: liraglutide | insulin secretagogues peptides (incretins) for diabetes

    Treatments

    Studied treatment Liraglutide 1.2–1.8 mg daily
    Control treatment Glimepiride 8 mg once daily or Glimepiride 8 mg once daily
    Concomittant treatment None

    Patients

    Patients subjects with type 2 diabetes
    Inclusion criteria 1) Type 2 diabetes; 2) Treatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months; 3) Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive; 4) OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%, inclusive; 5) Body Mass Index (BMI) less than or equal to 45 kg/m2;
    Exclusion criteria 1) Treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness; 2) Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound); 3) Any serious medical condition;
    Baseline characteristics
    Age (year) 53 
    Duration of diabetes (year) 5.4 y 
    HbA1c (%) 8.3 
    BMI 33.1 
    Add-on to None 

    Method and design

    Randomized effectives 498 / 248 (studied vs. control)
    Blinding double blind
    Follow-up duration 52 weeks (104 weeks)
    Geographic area North America
    Primary endpoint Change in Glycosylated Haemoglobin A1c (HbA1c) , ,
    Remarks

    Remarks / Comments



    Results

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

    severe hypoglycemia

    0 / 498
         0 / 248
         classic 0,50 [0,00;127,03]

    vomiting

    57 / 498
         9 / 248
         classic 3,15 [1,59;6,26]

    All cause death

    0 / 498
         1 / 248
         classic 0,10 [0,00;7,28]

    all hypoglycemia

    50 / 498
         58 / 248
         0,43 [0,30;0,61]

    nausea

    139 / 498
         21 / 248
         classic 3,30 [2,14;5,08]

    diarrhoea

    85 / 498
         22 / 248
         classic 1,92 [1,23;3,00]     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 / 498 (0,1%) 0 / 248 (0,2%) 0,50 [0,01;25,02] 12053
    vomiting 57 / 498 (11,4%) 9 / 248 (3,6%) 3,15 [1,59;6,26] 12053
    all hypoglycemia 50 / 498 (10,0%) 58 / 248 (23,4%) 0,43 [0,30;0,61] 12053
    nausea 139 / 498 (27,9%) 21 / 248 (8,5%) 3,30 [2,14;5,08] 0
    diarrhoea 85 / 498 (17,1%) 22 / 248 (8,9%) 1,92 [1,23;3,00] 12053
    All cause death 0 / 498 (0,1%) 1 / 248 (0,4%) 0,25 [0,01;7,40] 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 11,45% 3,63% 7,8%
    all hypoglycemia 10,04% 23,39% -133,5‰
    nausea 27,91% 8,47% 19,4%
    diarrhoea 17,07% 8,87% 8,2%

    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 # NCT00294723
    • Garber A, Henry R, Ratner R, Garcia-Hernandez PA, Rodriguez-Pattzi H, Olvera-Alvarez I, Hale PM, Zdravkovic M, Bode B. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial.. Lancet 2009;373:473-81 - 10.1016/S0140-6736(08)61246-5
      Pubmed | Hubmed | Fulltext

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