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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01731431
• Date of registration: 11/09/2012
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes INDAO
• Scientific title: Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes
• Date of first enrolment: May 18, 2012
• Target sample size: 914
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01731431
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Marie-Victoire SENAT, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Diabetes

Gestational

Intervention(s)

Drug: Glyburide

Other: Insulin

Primary Outcome(s)

Composite criterion of neonatal complications associated with gestational diabetes: macrosomia or birth weight = 90th percentile for gestational age, neonatal hypoglycemia and neonatal hyperbilirubinemia [Time Frame: At birth until neonatal discharge from maternity]

Secondary Outcome(s)

Rates of caesarean section, preterm delivery rate, neonatal mortality rate, number of neonatal and maternal trauma related to delivery, number of respiratory distress, number of prenatal visits, number of days of hospitalization [Time Frame: during pregnancy until maternal discharge from maternity]

Secondary ID(s)

P110104

Source(s) of Monetary Support

Please refer to primary and secondary sponsors