Glyburide vs Glucovance in the Treatment of GDM (GGIG)

Glyburide vs Glucovance in the Treatment of Gestational Diabetes

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

Study Overview

• Status: Terminated
• Conditions: Gestational Diabetes
• Intervention / Treatment: Drug: Glyburide; Drug: Glucovance

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79905
      • TTUHSC El Paso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Glyburide; glyburide 2.5milligrams (mg) at bedtime (qhs) increased as needed to a maximum of 20mg/day usually taken twice a day (BID); Other Names: micronase; diabeta; glynase
Active Comparator: 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.	Drug: Glucovance; glucovance (2.5/500) 1 taken orally (PO) at bed time (QHS) increased as needed to a maximum dose of (20/2000)/day usually taken twice a day (BID); Other Names: combination glyburide and metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of glyburide compared to glucovance	failure rate of glyburide compared to glucovance in ability to achieve euglycemia	during the index pregnancy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center, El Paso
• Investigators: Principal Investigator: Lisa E Moore, MD, Texas Tech Health Sciences Center El Paso

Publications and helpful links

General Publications

• Moore LE, Clokey D, Rappaport VJ, Curet LB. Metformin compared with glyburide in gestational diabetes: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):55-59. doi: 10.1097/AOG.0b013e3181c52132.
• Moore LE, Briery CM, Clokey D, Martin RW, Williford NJ, Bofill JA, Morrison JC. Metformin and insulin in the management of gestational diabetes mellitus: preliminary results of a comparison. J Reprod Med. 2007 Nov;52(11):1011-5.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): August 14, 2018
• Study Completion (Actual): August 14, 2018

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: gestational diabetes, pregnancy, diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin; Glyburide
• Other Study ID Numbers: E16008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No