Glyburide vs Glucovance in the Treatment of GDM (GGIG)

Texas Tech University Health Sciences Center, El Paso

Status and phase: Terminated; Early Phase 1

Conditions: Gestational Diabetes

Treatments: Drug: Glyburide; Drug: Glucovance

Study type: Interventional

Funder types: Other

Identifiers

NCT02726490

E16008

Details and patient eligibility

About

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

Full 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.

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Glyburide

Active Comparator group

Description:

* 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

Treatment:

Drug: Glyburide

Glucovance

Active Comparator group

Description:

* 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.

Treatment:

Drug: Glucovance