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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
  •  

    Vilsboll study, 2008

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

    Treatments

    Studied treatment Liraglutide 0.65–1.90 mg daily
    Control treatment Placebo
    Concomittant treatment None

    Patients

    Patients patients with Type 2 diabetes
    Baseline characteristics
    Age (year) 55  
    Duration of diabetes (year) 5.0 y 
    HbA1c (%) 8.3 
    BMI 30.0 
    Add-on to None 

    Method and design

    Randomized effectives 123 / 40 (studied vs. control)
    Design parallel groups
    Blinding double blind (not adequate)
    Follow-up duration 14 weeks


    Results

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

    severe hypoglycemia

    0 / 123
    0 / 40
    classic 0,33 [0,00;82,18]

    vomiting

    4 / 123
    0 / 40
    classic 5,53 [0,10;307,28]

    cardiovascular events

    0 / 123
    0 / 40
    classic 0,33 [0,00;82,18]

    all hypoglycemia

    0 / 123
    0 / 40
    classic 0,33 [0,00;82,18]

    nausea

    9 / 123
    1 / 40
    classic 2,93 [0,38;22,40]

    diarrhoea

    26 / 123
    5 / 40
    classic 1,69 [0,70;4,11]

    All cause death

    0 / 123
    0 / 40
    classic 0,33 [0,00;82,18]
    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 / 123 (0,4%) 0 / 40 (1,3%) 0,33 [0,01;16,13] 12053
    vomiting 4 / 123 (3,3%) 0 / 40 (1,3%) 2,60 [0,14;48,15] 12053
    cardiovascular events 0 / 123 (0,4%) 0 / 40 (1,3%) 0,33 [0,01;16,13] 12053
    all hypoglycemia 0 / 123 (0,4%) 0 / 40 (1,3%) 0,33 [0,01;16,13] 12053
    nausea 9 / 123 (7,3%) 1 / 40 (2,5%) 2,93 [0,38;22,40] 0
    diarrhoea 26 / 123 (21,1%) 5 / 40 (12,5%) 1,69 [0,70;4,11] 12053
    All cause death 0 / 123 (0,4%) 0 / 40 (1,3%) 0,33 [0,01;16,13] 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.
    nausea 7,32% 2,50% 4,8%
    diarrhoea 21,14% 12,50% 8,6%

    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 # NA
    • Vilsbøll T, Brock B, Perrild H, Levin K, Lervang HH, Kølendorf K, Krarup T, Schmitz O, Zdravkovic M, Le-Thi T, Madsbad S. Liraglutide, a once-daily human GLP-1 analogue, improves pancreatic B-cell function and arginine-stimulated insulin secretion during hyperglycaemia in patients with Type 2 diabetes mellitus.. Diabet Med 2008;25:152-6 - 10.1111/j.1464-5491.2007.02333.x
      Pubmed | Hubmed | Fulltext

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