Metformin Compared to Glyburide in Gestational Diabetes

Not Applicable

Completed

• Conditions: Gestational Diabetes
• Interventions: Drug: Glyburide; Drug: metformin

• Registration Number: NCT00965991
• Lead Sponsor: University of New Mexico

Brief 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.

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2008-05
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-26
• Study Completion: 2023-08
• Results First Submitted: 2023-08-23
• Results First Submitted QC: 2023-12-01
• Results First Posted: 2023-12-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 149

Inclusion Criteria

• Gestational diabetes not controlled with diet and exercise

Exclusion Criteria

• history of alcohol misuse
• history of drug misuse
• Chronic hypertension requiring medication
• Renal failure
• Hepatic disease or dysfunction
• Known fetal anomaly
• Inability to give consent
• known allergy to metformin or glyburide

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glyburide	Glyburide	-
Metformin	metformin	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Assessed for Glucose Control	fasting and 2 hour postprandial blood glucose	The importance of exercise in the management of blood glucose was emphasized, and 30 minutes of walking per day was recommended. Patients received instruction from a nurse educator or a certified diabetes educator regarding diet and the use of the glucometer. Number of participants with a glucose level \<100 mg/dL.

Trial Locations

Locations (1)

University of New Mexico Diabetes in Pregnancy Clinic; 🇺🇸 Albuquerque, New Mexico, United States