Failure Rate of GLyburide And Metformin Among Gestational Diabetics (GLAM)

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 4

Conditions: Gestational Diabetes Mellitus, Class A2

Treatments: Drug: Glyburide; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT03078725

HSC-MS-16-1052

Details and patient eligibility

About

A pragmatic, comparative effectiveness trial of glyburide versus metformin.

Full description

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.

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Glyburide

Active Comparator group

Description:

hypoglycemic agent approved for treatment of GDMA2

Treatment:

Drug: Glyburide

Metformin

Active Comparator group

Description:

hypoglycemic agent approved for treatment of GDMA2

Treatment:

Drug: Metformin