Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

Study Overview
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Brief Summary
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This is a randomized prospective trial which addresses the question of whether use of an oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will result in achieving euglycemia in a shorter period of time and, in turn, result in less frequent maternal and neonatal morbidities. This study is designed to test the hypothesis that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling alone.

Official Title
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A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

Conditions
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Mild Gestational Diabetes

Intervention / Treatment
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* Drug: Glyburide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A glucose value of ≥140 mg/dl on a 50-gram oral glucose loading test by plasma at gestational age between 24 weeks 0 days and 27 weeks 6 days based on clinical information An Abnormal 3-hour oral glucose tolerance test with a fasting glucose of ≤105 mg/dl Gestational age of less than or equal to 28 weeks and 0 days at the time of consent/randomization Singleton gestation Exclusion Criteria: Established pregestational diabetes Abnormal gestational diabetes testing (≥140) prior to 24 weeks 0 days of gestation. Women who have a negative glucose loading test (<140mg/dl) before 24 weeks may still be considered for this study if they present again for glucose tolerance testing between 24 and 27 weeks. Multiple gestations Known major fetal anomaly or fetal demise Any renal disease with serum creatinine of >1.0 Known liver disease such as hepatitis Maternal or fetal conditions likely to require imminent or very preterm delivery such as preeclampsia, preterm premature rupture of the membranes, preterm labor, and intrauterine fetal growth restriction Known hypersensitivity or allergic reaction to Glyburide

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glyburide<br>Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control. | Drug: Glyburide<br>* Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.<br>|
| Placebo Comparator: Placebo<br>Women with mild gestational diabetes will be started ADA diet and placebo. | Drug: Placebo<br>* Sham dose adjustments of the placebo will be made.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Fetal Weight at Birth |  | Immediately after delivery of fetus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Large for Gestational Age Infants | Birth weight exceeding the 90th percentile for the gestational age at delivery. | After delivery | 
| Macrosomia | birth weight 4,000 g or greater | After delivery | 
| Neonatal Intensive Care Unit Admissions |  | Until hospital discharge | 
| Rate of Cesarean Delivery |  | After delivery | 
| Diagnosis of Pregnancy-induced Hypertension |  | until hospital discharge | 
| Shoulder Dystocia |  | at delivery | 
| Need for Insulin Treatment |  | after delivery | 
| 3rd or 4th Degree Perineal Laceration |  | at delivery | 
| Chorioamnionitis | Maternal fever >=38.0°C | intrapartum | 
| Need for Insulin Therapy |  | throughout pregnancy and delivery |