Glyburide vs Glucovance in the Treatment of GDM

Study Overview
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Brief Summary
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A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management of diabetes in pregnancy.

Detailed Description
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This study will be a randomized open label trial of glyburide compared to glucovance in the management of gestational diabetes. We hypothesize that glucovance will provide improved glycemic control and a lower failure rate with no increase in neonatal adverse outcomes. Sixty-seven patients will be randomized by computer to each arm of the study. Outcomes will be glycemic control, failure rate of the drug to achieve glycemic goals, and neonatal outcomes.

Official Title
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Glyburide vs Glucovance in the Treatment of Gestational Diabetes

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Drug: Glyburide
* Drug: Glucovance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational diabetes Pregnancy > 12 weeks gestation Ability to give consent Exclusion Criteria: Inability to consent to the study Pre-existing diabetes Glucose-6-phosphate dehydrogenase (G6PD) deficiency Serum creatinine >1 Liver disease Allergy to sulfa; Allergy to glyburide; Allergy to metformin; Fetal anomalies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Glyburide<br>Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals. The starting dose of glyburide may be 2.5milligrams (mg) to 5mg every day(QD) or twice daily (BID) depending on the degree of hyperglycemia. The dose of glyburide will be increased as needed to a maximum of 20mg /day. Antenatal testing will be initiated at 28 weeks Patients will receive monthly growth scans | Drug: Glyburide<br>* glyburide 2.5milligrams (mg) at bedtime (qhs) increased as needed to a maximum of 20mg/day usually taken twice a day (BID)<br>* Other names: glynase;|
| Active Comparator: Glucovance<br>Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals. The starting dose of glucovance may be 1.25/250milligrams (mg) either once daily (QD) or twice a day (BID) increased to a maximum of 20mg/2000mg as needed. Patients will receive monthly growth scans Antenatal testing will be initiated at 28 weeks. | Drug: Glucovance<br>* glucovance (2.5/500) 1 taken orally (PO) at bed time (QHS) increased as needed to a maximum dose of (20/2000)/day usually taken twice a day (BID)<br>* Other names: combination glyburide and metformin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of glyburide compared to glucovance | failure rate of glyburide compared to glucovance in ability to achieve euglycemia | during the index pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal hypoglycemia | the rate of maternal hypoglycemia associated with each drug | during the index pregnancy | 
| neonatal birthweight | infant weight at birth | at birth | 
| neonatal apgar scores | infant 1 minute and 5 minute apgar scores | at birth | 
| neonatal admission to the newborn intensive care unit (NICU) | admission to the Newborn intensive care unit (NICU) | at birth or within the first 24 hours after birth | 
| neonatal hypoglycemia | failure of the neonate to maintain blood glucose > 60 milligrams/deciliter (mg/dl) | up to 24 hours after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes, pregnancy, diabetes