Glyburide vs Glucovance in the Treatment of GDM

Early Phase 1

Terminated

• Conditions: Gestational Diabetes
• Interventions: Drug: Glyburide; Drug: Glucovance

• Registration Number: NCT02726490
• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

Brief Summary

A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management of diabetes in pregnancy.

Detailed Description

This study will be a randomized open label trial of glyburide compared to glucovance in the management of gestational diabetes. We hypothesize that glucovance will provide improved glycemic control and a lower failure rate with no increase in neonatal adverse outcomes. Sixty-seven patients will be randomized by computer to each arm of the study. Outcomes will be glycemic control, failure rate of the drug to achieve glycemic goals, and neonatal outcomes.

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-01
• Study Start: 2016-07
• Primary Completion: 2018-08-14
• Study Completion: 2018-08-14
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

• Gestational diabetes
• Pregnancy > 12 weeks gestation
• Ability to give consent

Exclusion Criteria

• Inability to consent to the study
• Pre-existing diabetes
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Serum creatinine >1
• Liver disease
• Allergy to sulfa;
• Allergy to glyburide;
• Allergy to metformin;
• Fetal anomalies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glyburide	Glyburide	* Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals. * The starting dose of glyburide may be 2.5milligrams (mg) to 5mg every day(QD) or twice daily (BID) depending on the degree of hyperglycemia. * The dose of glyburide will be increased as needed to a maximum of 20mg /day. * Antenatal testing will be initiated at 28 weeks * Patients will receive monthly growth scans
Glucovance	Glucovance	* Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals. * The starting dose of glucovance may be 1.25/250milligrams (mg) either once daily (QD) or twice a day (BID) increased to a maximum of 20mg/2000mg as needed. * Patients will receive monthly growth scans * Antenatal testing will be initiated at 28 weeks.

Primary Outcome Measures

Name	Time	Method
efficacy of glyburide compared to glucovance	during the index pregnancy	failure rate of glyburide compared to glucovance in ability to achieve euglycemia

Secondary Outcome Measures

Name	Time	Method
maternal hypoglycemia	during the index pregnancy	the rate of maternal hypoglycemia associated with each drug
neonatal birthweight	at birth	infant weight at birth
neonatal apgar scores	at birth	infant 1 minute and 5 minute apgar scores
neonatal admission to the newborn intensive care unit (NICU)	at birth or within the first 24 hours after birth	admission to the Newborn intensive care unit (NICU)
neonatal hypoglycemia	up to 24 hours after delivery	failure of the neonate to maintain blood glucose \> 60 milligrams/deciliter (mg/dl)

Trial Locations

Locations (1)

TTUHSC El Paso; 🇺🇸 El Paso, Texas, United States