Metformin Compared to Glyburide in Gestational Diabetes

Official Title: “A Randomized Prospective Trial of Metformin Compared to Glyburide in Gestational Diabetes”

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.

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Metformin
• Active Comparator: Glyburide

Primary Measures

• glucose control
  • Time Frame: fasting and 2 hour postprandial blood glucose
    Safety Issue?: No

Secondary Measures

• birthweight
  • Time Frame: postpartum
    Safety Issue?: No
• delivery method
  • Time Frame: postpartum
    Safety Issue?: No
• failure rate of the drug to control blood glucose
  • Time Frame: at weekly visit
    Safety Issue?: No
• fetal macrosomia
  • Time Frame: postpartum
    Safety Issue?: No
• neonatal hypoglycemia
  • Time Frame: postpartum
    Safety Issue?: No
• maternal hypoglycemia
  • Time Frame: postpartum
    Safety Issue?: No
• birth trauma
  • Time Frame: postpartum
    Safety Issue?: No
• NICU admission
  • Time Frame: postpartum
    Safety Issue?: No
• APGARs
  • Time Frame: postpartum
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: University of New Mexico Other

Overall Clinical Trial Officials and Contacts

Lisa E Moore, MD Principal Investigator University of New Mexico  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00965991

Study ID Number: HRRC#03-277

ClinicalTrials.gov Identifier: NCT00965991

Health Authority: United States: Institutional Review Board