Failure Rate of GLyburide And Metformin Among Gestational Diabetics

Phase 4

Withdrawn

• Conditions: Gestational Diabetes Mellitus, Class A2
• Interventions: Drug: Glyburide; Drug: Metformin

• Registration Number: NCT03078725
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

A pragmatic, comparative effectiveness trial of glyburide versus metformin.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-13
• Study Start: 2017-06-20
• Primary Completion: 2018-03-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-04
• Study Completion: 2018-05-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glyburide	Glyburide	hypoglycemic agent approved for treatment of GDMA2
Metformin	Metformin	hypoglycemic agent approved for treatment of GDMA2

Primary Outcome Measures

Name	Time	Method
Failure rate	from onset of oral therapy until delivery	need to start insulin therapy or another hypoglycemic agent during the pregnancy to maintain normal glucose levels or need for delivery due to hyperglycemia.

Secondary Outcome Measures

Name	Time	Method
Mean overall plasma glucose	from enrollment to delivery	average of all postprandial glucose measurements
LGA infant	from enrollment to delivery	LGA infant
Mean weekly fasting glucose	from enrollment to delivery	average of all fasting glucose measurements
preeclampsia	from enrollment to delivery	preeclampsia
cesarean section	from enrollment to delivery	mode of delivery
neonatal hypoglycemia	from enrollment to delivery	neonatal hypoglycemia
birthweight > 4500 grams	from enrollment to deliveryfrom enrollment to delivery	birthweight \> 4500 grams
gestational age at birth	from enrollment to delivery	gestational age at birth
incidence of medication side effects	from enrollment to delivery	nausea, emesis, diarrhea, abdomainal bloating