Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Mild Gestational Diabetes	Drug: Glyburide; Drug: Placebo	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	395 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
Study Start Date :	August 2008
Actual Primary Completion Date :	January 2013
Actual Study Completion Date :	January 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Fetal weight reduction of 200gm with Glyburide treatment [ Time Frame: Immediately after delivery of fetus ]

Secondary Outcome Measures :

1. Large for gestational age infants [ Time Frame: After delivery ]
2. Macrosomia [ Time Frame: After delivery ]
3. Neonatal Intensive Care Unit admissions [ Time Frame: Until hospital discharge ]
4. Rate of cesarean delivery [ Time Frame: After delivery ]
5. Risk of preeclampsia [ Time Frame: until hospital discharge ]
6. Time to achieve glycemic control [ Time Frame: after delivery ]
7. Need for insulin treatment [ Time Frame: after delivery ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	16 Years to 45 Years (Child, Adult)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University of Texas Southwestern Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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 ( Other Identifier: UTexasSouthwestern )
First Posted:	September 1, 2008
Last Update Posted:	January 26, 2017
Last Verified:	January 2017

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