Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes
Condition: Diabetes; Gestational
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical trial aims to test whether glibenclamide is non-inferior to insulin for the
      treatment of gestational diabetes.
    

Detailed description: 
      In patients with gestational diabetes, a therapeutic treatment with a diet, a blood glucose
      monitoring and, if necessary, treatment with insulin is associated with reduced neonatal
      complications. Although the effectiveness of insulin is proven, this therapy has many
      drawbacks, especially in terms of implementation and monitoring by women. An alternative is
      the use of oral antidiabetic agents like glibenclamide.

      Assumption: Glibenclamide is non-inferior to insulin for the treatment of gestational
      diabetes.

      Main objective: To test the oral Glibenclamide is non-inferior to subcutaneous insulin for
      the occurrence of perinatal complications in the management of pregnant women developing
      gestational diabetes and requiring treatment other than dietary.

      Secondary Objective: To test the noninferiority of two treatments on maternal glycemic
      control and maternal complications.

      Sample size: With a 80% power and a significance level of 5%, 450 subjects per group are
      required to show that treatment with glibenclamide is not considered inferior to treatment
      with insulin if the frequency of outcome composite does not exceed 25% with glibenclamide,
      whereas it was 18% with insulin (calculated with a non-inferiority margin of 7% and
      considering that 20% of patients treated with glyburide and Insulin for change half of the
      patients accept randomization).

      Progress of the study: Inclusion of women between 24 and 34 weeks. Randomization between
      Insulin and Glibenclamide after failure of 10 days of dietary treatment well done. Failure
      defined by at least 2 abnormal values of glycemia: fasting glucose ≥ 0.95 g / l and/or a
      postprandial 2h ≥ 1.20 g / l.

      Women will receive either insulin according to the usual protocol or Glibenclamide at an
      initial dose of 2.5 mg / once daily in the morning before breakfast. So long as the glycemic
      targets will not be reached doses are gradually increased stepwise every 4 days until day 21
      (20mg/j) . Patients who have not reached the glycemic targets at this highest dose will have
      a change in treatment for insulin at day 21. Routine monitoring of pregnant women with
      gestational diabetes, up to a week after delivery Number of clinical sites: 15 Perspective:
      Use of Glibenclamide as a first line treatment of gestational diabetes requiring drug
      treatment.
    

Intervention name(s): Insulin; Glyburide
Intervention type(s): Other; Drug
Intervention MeSH terms: Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gestational Diabetes,; Insulin,; Glyburide,; Glycemia