Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo - Full Text View

Sponsor:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00744965

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 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
Mild Gestational Diabetes	Drug: Glyburide Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Glyburide

U.S. FDA Resources

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

Primary Outcome Measures:

Fetal weight reduction of 200gm with Glyburide treatment [ Time Frame: Immediately after delivery of fetus ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	400
Study Start Date:	August 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: Glyburide Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Placebo Comparator: 2 Women with mild gestational diabetes will be started ADA diet and placebo.	Drug: Placebo Sham dose adjustments of the placebo will be made.

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 (<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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744965

Contacts

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

Locations

United States, Texas
Parkland Memorial Hospital	Not yet recruiting
Dallas, Texas, United States, 75235
Contact: Mina Abbassi-Ghanavati, MD 214-648-2646 mina.abbassi-ghanavati@utsouthwestern.edu
Principal Investigator: Mina Abbassi-Ghanavati, MD

Sponsors and Collaborators

University of Texas Southwestern Medical Center

More Information

No publications provided

Responsible Party:	Mina Abbassi-Ghanavati, UT Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00744965 History of Changes
Other Study ID Numbers:	042008-058
Study First Received:	August 29, 2008
Last Updated:	August 29, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Pregnancy Complications
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012