NCT00965991

Metformin Compared to Glyburide in Gestational Diabetes

A Randomized Prospective Trial of Metformin Compared to Glyburide in Gestational Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: Female
• Age: 13 Years
• Healthy volunteers: Accepted

Summary

Our hypothesis is that metformin and glyburide will have equal efficacy in controlling blood glucose in gestational diabetics with no increase in adverse maternal, fetal or neonatal outcomes.

Detailed description

Pregnant women are screened with a one hour 50g glucose challenge. Women with values of 130 mg/dl or greater are then given a 100g glucose tolerance test. Two abnormal values are diagnostic of gestational diabetes. all women are initially counseled on diet and exercise. Women who fail to maintain a fasting of \<105mg/dl and 2 hr postprandial \< 120 mg/dl are offered participation in the study. Women were randomized to either metformin or glyburide via a computer generated randomization. Women who fail to meet glycemic goals after receiving the maximum dose of study medication were considered treatment failures and insulin therapy was initiated.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DRUG	metformin	patients received glyburide initial dose of 500 mg PO BID. Increased as necessary to a maximum dose of 2000 mg QD to control blood glucose
DRUG	Glyburide	Initial dose of 2.5mg PO BID increased as necessary to a maximum dose of 20 mg (10mg BID) QD to control blood glucose

Timeline

• Start date: 2003-07-01
• Primary completion: 2008-05-01
• Completion: 2023-08-01
• First posted: 2009-08-26
• Last updated: 2024-11-19
• Results posted: 2023-12-21

Locations

1 site across 1 country: United States