Overview

This trial is active, not recruiting.

Condition mild gestational diabetes
Treatments glyburide, placebo
Phase phase 4
Sponsor University of Texas Southwestern Medical Center
Start date August 2008
End date January 2013
Trial size 395 participants
Trial identifier NCT00744965, 032011-086, 042008-058

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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.
glyburide
Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
(Placebo Comparator)
Women with mild gestational diabetes will be started ADA diet and placebo.
placebo
Sham dose adjustments of the placebo will be made.

Primary Outcomes

Measure
Fetal weight reduction of 200gm with Glyburide treatment
time frame: Immediately after delivery of fetus

Secondary Outcomes

Measure
Large for gestational age infants
time frame: After delivery
Macrosomia
time frame: After delivery
Neonatal Intensive Care Unit admissions
time frame: Until hospital discharge
Rate of cesarean delivery
time frame: After delivery
Risk of preeclampsia
time frame: until hospital discharge
Time to achieve glycemic control
time frame: after delivery
Need for insulin treatment
time frame: after delivery

Eligibility Criteria

Female participants from 16 years up to 45 years old.

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

Additional Information

Official title A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center.