Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

Phase 4

Completed

• Conditions: Mild Gestational Diabetes
• Interventions: Drug: Placebo; Drug: Glyburide

• Registration Number: NCT00744965
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-29
• Study First Submitted QC: 2008-08-29
• Study First Posted: 2008-09-01
• Study Start: 2008-09-16
• Primary Completion: 2013-01
• Study Completion: 2016-01
• Results First Submitted: 2019-03-21
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-06
• Last Update Submitted: 2020-03-06
• Results First Posted: 2020-03-12
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 395

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Women with mild gestational diabetes will be started ADA diet and placebo.
Glyburide	Glyburide	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.

Primary Outcome Measures

Name	Time	Method
Mean Fetal Weight at Birth	Immediately after delivery of fetus

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Large for Gestational Age Infants	After delivery	Birth weight exceeding the 90th percentile for the gestational age at delivery.
Macrosomia	After delivery	birth weight 4,000 g or greater
Neonatal Intensive Care Unit Admissions	Until hospital discharge
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	intrapartum	Maternal fever \>=38.0°C
Need for Insulin Therapy	throughout pregnancy and delivery
Rate of Cesarean Delivery	After delivery

Trial Locations

Locations (1)

Parkland Memorial Hospital; 🇺🇸 Dallas, Texas, United States