Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Brian Casey, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00744965
First received: August 29, 2008
Last updated: March 24, 2015
Last verified: March 2015

August 29, 2008
March 24, 2015
August 2008
January 2013   (final data collection date for primary outcome measure)
Fetal weight reduction of 200gm with Glyburide treatment [ Time Frame: Immediately after delivery of fetus ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00744965 on ClinicalTrials.gov Archive Site
  • Large for gestational age infants [ Time Frame: After delivery ] [ Designated as safety issue: No ]
  • Macrosomia [ Time Frame: After delivery ] [ Designated as safety issue: No ]
  • Neonatal Intensive Care Unit admissions [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]
  • Rate of cesarean delivery [ Time Frame: After delivery ] [ Designated as safety issue: No ]
  • Risk of preeclampsia [ Time Frame: until hospital discharge ] [ Designated as safety issue: No ]
  • Time to achieve glycemic control [ Time Frame: after delivery ] [ Designated as safety issue: No ]
  • Need for insulin treatment [ Time Frame: after delivery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
A Randomized Controlled Clinical Trial of 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 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Mild Gestational Diabetes
  • 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.
  • Active Comparator: 1
    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.
    Intervention: Drug: Glyburide
  • Placebo Comparator: 2
    Women with mild gestational diabetes will be started ADA diet and placebo.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
395
January 2016
January 2013   (final data collection date for primary outcome measure)

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
Female
16 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00744965
032011-086, 042008-058
No
Brian Casey, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Not Provided
University of Texas Southwestern Medical Center
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP