Overview

Failure Rate of GLyburide And Metformin Among Gestational Diabetics

Status:
Withdrawn
Trial end date:
2018-05-10
Target enrollment:
0
Participant gender:
Female
Summary
A pragmatic, comparative effectiveness trial of glyburide versus metformin.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston
Treatments:
Glyburide
Hypoglycemic Agents
Metformin
Criteria
Inclusion Criteria:

We will include women between 20 and 34 weeks gestational age, with a diagnosis of GDM as
per the following criteria:

- 1 hour Glucose tolerance test of >130 mg/dl, followed by two abnormal values on 3 hour
Glucose tolerance test, or:

- A single 1 hour Glucose tolerance test value of > 200 mg/dl, and:

- Failure to achieve glycemic control with diet and exercise or deemed to require
pharmacological therapy as per physician's criteria

Exclusion Criteria:

- - Known renal impairment.

- Known hepatic disease.

- Pre-gestational diabetes.

- Known allergy to glyburide, metformin or sulfa drugs.