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

Phase 3 Completed 914 enrolled Assistance Publique - Hôpitaux de Paris URC-CIC Paris Descartes Necker Cochin · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2012-05-18
Primary completion: 2017-03-15
Completion: 2017-06-02

Outcome

Missed primary endpoint

paper a difference of 4.2% (1-sided 97.5% CI, -∞ to 10.5%; P=.19). PMID 29715355 ↗

paper This study of women with gestational diabetes failed to show that use of glyburide compared with subcutaneous insulin does not result in a greater frequency of perinatal complications. PMID 29715355 ↗

Publications

Results Senat MV, Affres H, Letourneau A, Coustols-Valat M, Cazaubiel M, Legardeur H, Jacquier JF, Bourcigaux N, Simon E, Rod A, Heron I, Castera V, Sentilhes L, Bretelle F, Rolland C, Morin M, Deruelle P, De Carne C, Maillot F, Beucher G, Verspyck E, Desbriere R, Laboureau S, Mitanchez D, Bouyer J; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Effect of Glyburide vs Subcutaneous Insulin on Perinatal Complications Among Women With Gestational Diabetes: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1773-1780. doi: 10.1001/jama.2018.4072.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glyburide	Small molecule	10 mg	Oral