Failure Rate of GLyburide And Metformin Among Gestational Diabetics

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2018-05-10

Brief Summary

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A pragmatic, comparative effectiveness trial of glyburide versus metformin.

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Detailed Description

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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.

Conditions

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Gestational Diabetes Mellitus, Class A2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients will be randomized to two groups, one receiving glyburide and one receiving metformin.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glyburide

hypoglycemic agent approved for treatment of GDMA2

Group Type ACTIVE_COMPARATOR

Glyburide

Intervention Type DRUG

oral hypoglycemic agent

Metformin

hypoglycemic agent approved for treatment of GDMA2

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

oral hypoglycemic agent

Interventions

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Glyburide

oral hypoglycemic agent

Intervention Type DRUG

Metformin

oral hypoglycemic agent

Intervention Type DRUG

Eligibility Criteria

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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