Failure Rate of GLyburide And Metformin Among Gestational Diabetics

The University of Texas Health Science Center, Houston

Overview

A pragmatic, comparative effectiveness trial of glyburide versus metformin.

Patients with gestational diabetes requiring pharmaceutical treatment will be randomized to receive glyburide or metformin. Dose increases will be determined by the patient's physician. Patients will be determined to have failed either medication if glucose control can not be achieved with the maximum dose of the medication, if insulin is stared to achieve glucose control or if another oral agent is started along for glucose control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Gestational Diabetes Mellitus, Class A2

Interventions

GlyburideDRUG

oral hypoglycemic agent

MetforminDRUG

oral hypoglycemic agent

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Failure rate

need to start insulin therapy or another hypoglycemic agent during the pregnancy to maintain normal glucose levels or need for delivery due to hyperglycemia.

Time frame: from onset of oral therapy until delivery