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

Sponsor:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00942552

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 IV

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diets

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

Additional relevant MeSH terms:

Glyburide
Hypoglycemic Agents
Metabolic Diseases
Pregnancy Complications
Physiological Effects of Drugs

Diabetes Mellitus
Endocrine System Diseases
Diabetes, Gestational
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010