Metformin Compared to Glyburide in Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965991
• Other study ID #: HRRC#03-277
• Status: Completed
• Phase: N/A
• Start date: July 2003
• Est. completion date: August 2023

Study information

• Verified date: December 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: August 2023
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of New Mexico Diabetes in Pregnancy Clinic	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

References & Publications (1)

Moore LE, Clokey D, Rappaport VJ, Curet LB. Metformin compared with glyburide in gestational diabetes: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):55-59. doi: 10.1097/AOG.0b013e3181c52132. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Assessed for Glucose Control	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.	fasting and 2 hour postprandial blood glucose
Secondary	Neonatal and Obstetric Complications.		postpartum
Secondary	Failure Rate of the Drug to Control Blood Glucose		at weekly visit