Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes

• Status: Completed
• Trial end date: 2017-06-02
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Glyburide; Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• gestational diabetes diagnosed between 24 and 34 weeks according to international criteria.

Exclusion Criteria:

• Multiple Pregnancy

• Chronic Hypertension

• Preeclampsia

• Renal impairment

• Hepatic insufficiency

• Long time corticosteroids treatment

• Allergy to sulfa drugs

• Pre-existing diabetes in pregnancy

• Abnormal result on screening test for gestational diabetes before 24SA

• Fasting glucose ≥ 1.26 g / l at initial diagnosis of diabetes

• The need for drug treatment contraindicated or not recommended with taking Glibenclamide

• Poor understanding of French

• Lack of Social Insurance