Glyburide vs Glucovance in the Treatment of GDM

Gestational Diabetes Clinical Trial

— GGIG  

Official title:

Glyburide vs Glucovance in the Treatment of Gestational Diabetes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02726490
• Other study ID #: E16008
• Status: Terminated
• Phase: Early Phase 1
• Start date: July 2016
• Est. completion date: August 14, 2018

Study information

• Verified date: October 2020
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 14, 2018
• Est. primary completion date: August 14, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Drug:
• Glyburide
glyburide 2.5milligrams (mg) at bedtime (qhs) increased as needed to a maximum of 20mg/day usually taken twice a day (BID)
• 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)

Locations

Country	Name	City	State
United States	TTUHSC El Paso	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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):55-9. doi: 10.1097/AOG.0b013e3181c52132. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of glyburide compared to glucovance	failure rate of glyburide compared to glucovance in ability to achieve euglycemia	during the index pregnancy
Secondary	maternal hypoglycemia	the rate of maternal hypoglycemia associated with each drug	during the index pregnancy
Secondary	neonatal birthweight	infant weight at birth	at birth
Secondary	neonatal apgar scores	infant 1 minute and 5 minute apgar scores	at birth
Secondary	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
Secondary	neonatal hypoglycemia	failure of the neonate to maintain blood glucose > 60 milligrams/deciliter (mg/dl)	up to 24 hours after delivery