drugset / Trial / NCT00744965

Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

NCT00744965

Phase 4 Completed 395 enrolled University of Texas Southwestern Medical Center
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized prospective trial which addresses the question of whether use of an oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will result in achieving euglycemia in a shorter period of time and, in turn, result in less frequent maternal and neonatal morbidities. This study is designed to test the hypothesis that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling alone.

Timeline

Start
2008-09-16
Primary completion
2013-01
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glyburide Small molecule 2.5 mg Oral

Indications