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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-1 study, 0

    [NCT00318422] 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 sulphonylureas
    Concomittant treatment sulphonylureas

    Patients

    Inclusion criteria 1) Type 2 diabetes; 2) Treatment with oral anti-diabetic drugs for at least 3 months; 3) HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy; 4) Body Mass Index (BMI) less than or equal to 45.0 kg/m2.;
    Exclusion criteria 1) Treatment with insulin within the last three months; 2) Treatment with any drug that could interfere with the glucose level; 3) Any serious medical condition; 4) Females who are pregnant, have the intention of becoming pregnant or are breastfeeding;
    Baseline characteristics
    Age (year) 56 
    Duration of diabetes (year) 7.9 y 
    HbA1c (%) 8.4 
    BMI 30.0 
    Add-on to SU 

    Method and design

    Randomized effectives 695 / 115 (studied vs. control)
    Blinding not reported
    Follow-up duration 26 weeks
    Remarks

    Remarks / Comments



    Results

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

    nausea

    52 / 695
         2 / 115
         classic 4,30 [1,06;17,42]

    severe hypoglycemia

    1 / 695
         0 / 115
         classic 0,83 [0,01;60,34]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    severe hypoglycemia 1 / 695 (0,1%) 0 / 115 (0,4%) 0,33 [0,01;9,81] 12053
    nausea 52 / 695 (7,5%) 2 / 115 (1,7%) 4,30 [1,06;17,42] 0
    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.
    nausea 7,48% 1,74% 5,7%

    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 # NCT00318422

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