Treatment of Mild Gestational Diabetes With Glyburide Compared to Placebo

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00942552
First received: July 2, 2009
Last updated: July 19, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Gestational Diabetes
Pregnancy Complications
Drug: Glyburide
Drug: Placebo
Behavioral: ADA diet + nutritional counseling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Fetal weight reduction of 200 gm [ Time Frame: Immediately after delivery of fetus, 0-18 week from time of enrollment in the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Large for gestational age infants [ Time Frame: Immediately after delivery of fetus, 0-18 week from time of enrollment in the study ] [ Designated as safety issue: No ]
  • Macrosomia [ Time Frame: Immediately after delivery of fetus, 0-18 week from time of enrollment in the study ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Rate of cesarean delivery [ Time Frame: Immediately after delivery of fetus, 0-18 week from time of enrollment in the study ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2008
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Glyburide
Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Behavioral: ADA diet + nutritional counseling
Placebo Comparator: Placebo
Women with mild gestational diabetes will be started on ADA diet and placebo.
Drug: Placebo
Sham dose adjustments of the placebo will be made.
Behavioral: ADA diet + nutritional counseling

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942552

Contacts
Contact: Mina Abbassi-Ghanavati, MD 214-648-2646 mina.abbassi-ghanavati@utsouthwestern.edu
Contact: Keneth J Leveno, MD 214-648-2316 keneth.leveno@utsouthwestern.edu

Locations
United States, Texas
Parkland Memorial Hospital Recruiting
Dallas, Texas, United States, 75235
Principal Investigator: Mina Abbassi-Ghanavati, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Mina Abbassi-Ghanavati, MD UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Mina Abbassi-Ghanavati MD, UT Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00942552     History of Changes
Other Study ID Numbers: 042008-058-2
Study First Received: July 2, 2009
Last Updated: July 19, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Pregnancy Complications
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014