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

Tracking Information

First Received Date ^ICMJE

August 24, 2009

Last Updated Date

June 23, 2010

Start Date ^ICMJE

July 2003

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00965991 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Metformin Compared to Glyburide in Gestational Diabetes

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Gestational Diabetes

Intervention ^ICMJE

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
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

Study Arm (s)

Active Comparator: Metformin
Intervention: Drug: metformin
Active Comparator: Glyburide
Intervention: Drug: Glyburide

Publications *

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):55-9.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

149

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Female

Ages

13 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00965991

Other Study ID Numbers ^ICMJE

HRRC#03-277

Has Data Monitoring Committee

Responsible Party

Lisa E. Moore,MD, University of New Mexico

Study Sponsor ^ICMJE

University of New Mexico

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lisa E Moore, MD

University of New Mexico

Information Provided By

University of New Mexico

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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