Metformin Compared to Glyburide in Gestational Diabetes | RxWiki

Metformin Compared to Glyburide in Gestational Diabetes

Overview[ - collapse ][ - ]

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	Gestational Diabetes
Intervention	Drug: metformin Drug: Glyburide
Phase	N/A
Sponsor	University of New Mexico
Responsible Party	University of New Mexico
ClinicalTrials.gov Identifier	NCT00965991
First Received	August 24, 2009
Last Updated	June 23, 2010
Last verified	May 2008

Tracking Information[ + expand ][ + ]

First Received Date	August 24, 2009
Last Updated Date	June 23, 2010
Start Date	July 2003
Estimated Primary Completion Date	May 2008
Current Primary Outcome Measures	glucose control [Time Frame: fasting and 2 hour postprandial blood glucose] [Designated as safety issue: No]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	Metformin Compared to Glyburide in Gestational Diabetes
Official Title	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	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Gestational Diabetes
Intervention	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 Names: GlucophageDrug: 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 Names: sulfonylurea
Study Arm (s)	Active Comparator: Metformin Active Comparator: Glyburide

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	149
Estimated Completion Date	May 2008
Estimated Primary Completion Date	May 2008
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
Gender	Female
Ages	13 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00965991
Other Study ID Numbers	HRRC#03-277
Has Data Monitoring Committee	No
Information Provided By	University of New Mexico
Study Sponsor	University of New Mexico
Collaborators	Not Provided
Investigators	Principal Investigator: Lisa E Moore, MD University of New Mexico
Verification Date	May 2008

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