Status:
COMPLETED
Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Mild Gestational Diabetes
Eligibility:
FEMALE
16-45 years
Phase:
PHASE4
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 ac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT00744965
Start Date
September 16 2008
End Date
January 1 2016
Last Update
March 12 2020
Active Locations (1)
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1
Parkland Memorial Hospital
Dallas, Texas, United States, 75235