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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-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 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 # NCT00331851
    • Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Sim� 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, Sim� 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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