NCT02726490

Glyburide vs Glucovance in the Treatment of GDM

Glyburide vs Glucovance in the Treatment of Gestational Diabetes

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Texas Tech University Health Sciences Center, El Paso · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management of diabetes in pregnancy.

Detailed description

This study will be a randomized open label trial of glyburide compared to glucovance in the management of gestational diabetes. We hypothesize that glucovance will provide improved glycemic control and a lower failure rate with no increase in neonatal adverse outcomes. Sixty-seven patients will be randomized by computer to each arm of the study. Outcomes will be glycemic control, failure rate of the drug to achieve glycemic goals, and neonatal outcomes.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DRUG	Glyburide	glyburide 2.5milligrams (mg) at bedtime (qhs) increased as needed to a maximum of 20mg/day usually taken twice a day (BID)
DRUG	Glucovance	glucovance (2.5/500) 1 taken orally (PO) at bed time (QHS) increased as needed to a maximum dose of (20/2000)/day usually taken twice a day (BID)

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-08-14
• Completion: 2018-08-14
• First posted: 2016-04-01
• Last updated: 2020-10-12

Locations

1 site across 1 country: United States