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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-5 (vs Glargine) study, 0

    [NCT00331851] download pdf: liraglutide | insulin secretagogues peptides (incretins) for diabetes

    Treatments

    Studied treatment Liraglutide 1.8 mg daily
    Control treatment Glargine on-top of sulphonylureas+metformin
    Concomittant treatment sulphonylureas+/-metformin

    Patients

    Baseline characteristics
    Age (year) 57  
    Duration of diabetes (year) 9.4 y 
    HbA1c (%) 8.2 
    BMI 30.5 
    Add-on to SU+/-Met 

    Method and design

    Randomized effectives 230 / 232 (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]

    nausea

    32 / 230
         3 / 232
         classic 10,76 [3,34;34,64]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    nausea 32 / 230 (13,9%) 3 / 232 (1,3%) 10,76 [3,34;34,64] 0
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    nausea 13,91% 1,29% 12,6%

    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 # NCT00331851
    • Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Simó R, , . Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial.. Diabetologia 2009;52:2046-55. - 10.1007/s00125-009-1472-y
      Pubmed | Hubmed | Fulltext
    • Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Simó R. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial.. Diabetologia 2009 Oct;52:2046-55
      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 Feb 26;8:12
      Pubmed | Hubmed | Fulltext

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