Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Mild Gestational Diabetes

Treatments: Drug: Placebo; Drug: Glyburide

Study type: Interventional

Funder types: Other

Identifiers

NCT00744965

032011-086

042008-058 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 395 patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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395 participants in 2 patient groups, including a placebo group

Glyburide

Active Comparator group

Description:

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.

Treatment:

Drug: Glyburide

Placebo

Placebo Comparator group

Description:

Women with mild gestational diabetes will be started ADA diet and placebo.

Treatment:

Drug: Placebo