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

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 4


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:

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 ]


Enrollment:	395
Study Start Date:	August 2008
Estimated Study Completion Date:	January 2016
Primary Completion Date:	January 2013 (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 (Child, Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235

Sponsors and Collaborators

University of Texas Southwestern Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Brian Casey, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00744965 History of Changes
Obsolete Identifiers:	NCT00942552
Other Study ID Numbers:	032011-086 042008-058
Study First Received:	August 29, 2008
Last Updated:	March 24, 2015
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

ClinicalTrials.gov processed this record on September 26, 2016