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Metformin Compared to Glyburide in Gestational Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00965991
Recruitment Status : Completed
First Posted : August 26, 2009
Last Update Posted : June 25, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Gestational Diabetes Drug: metformin Drug: Glyburide

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Prospective Trial of Metformin Compared to Glyburide in Gestational Diabetes
Study Start Date : July 2003
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. glucose control [ Time Frame: fasting and 2 hour postprandial blood glucose ]

Secondary Outcome Measures :
  1. birthweight [ Time Frame: postpartum ]
  2. delivery method [ Time Frame: postpartum ]
  3. failure rate of the drug to control blood glucose [ Time Frame: at weekly visit ]
  4. fetal macrosomia [ Time Frame: postpartum ]
  5. neonatal hypoglycemia [ Time Frame: postpartum ]
  6. maternal hypoglycemia [ Time Frame: postpartum ]
  7. birth trauma [ Time Frame: postpartum ]
  8. NICU admission [ Time Frame: postpartum ]
  9. APGARs [ Time Frame: postpartum ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: June 25, 2010
Last Verified: May 2008

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
Metformin
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs