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Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

This study has been completed.
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: January 25, 2017
Last verified: January 2017

August 29, 2008
January 25, 2017
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 ]
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 ]
  • 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 ]
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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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
Casey BM, Duryea EL, Abbassi-Ghanavati M, Tudela CM, Shivvers SA, McIntire DD, Leveno KJ. Glyburide in Women With Mild Gestational Diabetes: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):303-9. doi: 10.1097/AOG.0000000000000967.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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
Sexes Eligible for Study: Female
16 Years to 45 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00744965
032011-086
042008-058 ( Other Identifier: UTexasSouthwestern )
No
Not Provided
Not Provided
Not Provided
Brian Casey, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Not Provided
University of Texas Southwestern Medical Center
January 2017

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