Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

NCT00744965 | Completed Phase 4 Results

• 2 other identifiers: 032011-086042008-058
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean Fetal Weight at Birth

  Immediately after delivery of fetus

Secondary Outcomes (10)

• Number of Participants With Large for Gestational Age Infants

  After delivery

• Macrosomia

  After delivery

• Neonatal Intensive Care Unit Admissions

  Until hospital discharge

• Rate of Cesarean Delivery

  After delivery

• Diagnosis of Pregnancy-induced Hypertension

  until hospital discharge

Study Arms (2)

Glyburide

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Glyburide DRUG

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

Glyburide

Placebo DRUG

Sham dose adjustments of the placebo will be made.

Placebo

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• 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.

  PMID: 26241419 RESULT

MeSH Terms

Interventions

Glyburide

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Limitations and Caveats

Sample size of 395 limits our ability to analyze the effect of Glyburide on uncommon pregnancy outcomes. The study was underpowered for outcomes other than birth weight difference.

Results Point of Contact

• Title: Kenneth J. Leveno, MD
• Organization: UT Southwestern Medical Center

kenneth.leveno@utsouthwestern.edu

214-648-2316

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: September 16, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2016
• Last Updated: March 12, 2020
• Results First Posted: March 12, 2020

Record last verified: 2020-03

Locations

US (1)