Glyburide vs Glucovance in the Treatment of GDM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-08-14

Brief Summary

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

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Detailed Description

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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.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Glyburide

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Glucovance

Intervention Type DRUG

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)

Interventions

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Glyburide

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

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

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micronase diabeta glynase combination glyburide and metformin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No