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Metformin Compared to Glyburide in Gestational Diabetes

This study has been completed.
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00965991
First received: August 24, 2009
Last updated: June 23, 2010
Last verified: May 2008
History of Changes
  Purpose

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.


Condition Intervention
Gestational Diabetes
 Drug: metformin
Drug: Glyburide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Prospective Trial of Metformin Compared to Glyburide in Gestational Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • glucose control [ Time Frame: fasting and 2 hour postprandial blood glucose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • birthweight [ Time Frame: postpartum ] [ Designated as safety issue: No ]
  • delivery method [ Time Frame: postpartum ] [ Designated as safety issue: No ]
  • failure rate of the drug to control blood glucose [ Time Frame: at weekly visit ] [ Designated as safety issue: No ]
  • fetal macrosomia [ Time Frame: postpartum ] [ Designated as safety issue: No ]
  • neonatal hypoglycemia [ Time Frame: postpartum ] [ Designated as safety issue: No ]
  • maternal hypoglycemia [ Time Frame: postpartum ] [ Designated as safety issue: No ]
  • birth trauma [ Time Frame: postpartum ] [ Designated as safety issue: No ]
  • NICU admission [ Time Frame: postpartum ] [ Designated as safety issue: No ]
  • APGARs [ Time Frame: postpartum ] [ Designated as safety issue: No ]

Enrollment: 149
Study Start Date: July 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin 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
Other Name: Glucophage
Active Comparator: Glyburide 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
Other Name: sulfonylurea

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965991

Locations
United States, New Mexico
University of New Mexico Diabetes in Pregnancy Clinic
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Lisa E Moore, MD University of New Mexico
  More Information

Publications:

Responsible Party: Lisa E. Moore,MD, University of New Mexico
ClinicalTrials.gov Identifier: NCT00965991     History of Changes
Other Study ID Numbers: HRRC#03-277
Study First Received: August 24, 2009
Last Updated: June 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Gestational diabetes
Metformin
Glyburide
oral agents

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
 Glyburide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013