Treatment of Mild Gestational Diabetes With Glyburide Compared to Placebo

Official Title: “Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo”

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 gestational diabetes mellitus (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.

Intervention(s) in this Clinical Trial

• Drug: Glyburide
  • Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
• Drug: Placebo
  • Sham dose adjustments of the placebo will be made.
• Behavioral: ADA diet + nutritional counseling

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Glyburide
  • Women with mild gestational diabetes will be started on ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control.
• Placebo Comparator: Placebo
  • Women with mild gestational diabetes will be started on ADA diet and placebo.

Primary Measures

• Fetal weight reduction of 200 gm
  • Time Frame: Immediately after delivery of fetus, 0-18 week from time of enrollment in the study
    Safety Issue?: No

Secondary Measures

• Large for gestational age infants
  • Time Frame: Immediately after delivery of fetus, 0-18 week from time of enrollment in the study
    Safety Issue?: No
• Macrosomia
  • Time Frame: Immediately after delivery of fetus, 0-18 week from time of enrollment in the study
    Safety Issue?: No
• Neonatal Intensive Care Unit admissions
  • Time Frame: From delivery until hospital discharge, 0-18 week from time of enrollment in the study
    Safety Issue?: No
• Risk of preeclampsia
  • Time Frame: From time of enrollment in the study until hospital discharge postpartum, 0-18 week from time of enrollment in the study
    Safety Issue?: No
• Rate of cesarean delivery
  • Time Frame: Immediately after delivery of fetus, 0-18 week from time of enrollment in the study
    Safety Issue?: No
• Time to achieve glycemic control
  • Time Frame: From the time of enrollment in the study until immediately after delivery, 0-18 week from time of enrollment in the study
    Safety Issue?: No
• Need for insulin treatment
  • Time Frame: From time of enrollment in the study until delivery, 0-18 week from time of enrollment in the study
    Safety Issue?: No

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 (< 140 mg/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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: University of Texas Southwestern Medical Center Other

Overall Clinical Trial Officials and Contacts

Mina Abbassi-Ghanavati, MD Principal Investigator UT Southwestern Medical Center  

Overall Contact: Mina Abbassi-Ghanavati, MD 214-648-2646 mina.abbassi-ghanavati@utsouthwestern.edu

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00942552

Study ID Number: 042008-058-2

ClinicalTrials.gov Identifier: NCT00942552

Health Authority: United States: Institutional Review Board