Metformin Compared to Glyburide in Gestational Diabetes

NCT ID: NCT00965991

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2023-08-31

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.

Conditions

Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin

Group Type: ACTIVE_COMPARATOR

metformin

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Glyburide

Intervention Type: DRUG

Initial dose of 2.5mg PO BID increased as necessary to a maximum dose of 20 mg (10mg BID) QD to control blood glucose

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Glucophage; sulfonylurea

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa E Moore, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

University of New Mexico Diabetes in Pregnancy Clinic

Albuquerque, New Mexico, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20027034 (View on PubMed)

Other Identifiers

HRRC#03-277

Identifier Type: -

Identifier Source: org_study_id