Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

NCT ID: NCT00744965

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 395 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-16
• Study Completion Date: 2016-01-31

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.

Conditions

Mild Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Glyburide

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.

Group Type: ACTIVE_COMPARATOR

Glyburide

Intervention Type: DRUG

Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.

Placebo

Women with mild gestational diabetes will be started ADA diet and placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sham dose adjustments of the placebo will be made.

Interventions

Glyburide

Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.

Intervention Type: DRUG

Placebo

Sham dose adjustments of the placebo will be made.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Leveno

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Parkland Memorial Hospital

Dallas, Texas, United States

Countries

United States

References

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):303-309. doi: 10.1097/AOG.0000000000000967.

Reference Type: RESULT

PMID: 26241419 (View on PubMed)

Other Identifiers

042008-058

Identifier Type: OTHER

Identifier Source: secondary_id

032011-086

Identifier Type: -

Identifier Source: org_study_id

NCT00942552

Identifier Type: -

Identifier Source: nct_alias