Metformin Compared to Glyburide in Gestational Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Drug: metformin
* Drug: Glyburide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br> | Drug: metformin<br>* 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<br>* Other names: Glucophage;|
| Active Comparator: Glyburide<br> | Drug: Glyburide<br>* Initial dose of 2.5mg PO BID increased as necessary to a maximum dose of 20 mg (10mg BID) QD to control blood glucose<br>* Other names: sulfonylurea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Assessed for Glucose Control | The importance of exercise in the management of blood glucose was emphasized, and 30 minutes of walking per day was recommended. Patients received instruction from a nurse educator or a certified diabetes educator regarding diet and the use of the glucometer. Number of participants with a glucose level <100 mg/dL. | fasting and 2 hour postprandial blood glucose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal and Obstetric Complications. |  | postpartum | 
| Failure Rate of the Drug to Control Blood Glucose |  | at weekly visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational diabetes, Metformin, Glyburide, oral agents