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

A pragmatic, comparative effectiveness trial of glyburide versus metformin.

Study Overview

• Status: Withdrawn
• Conditions: Gestational Diabetes Mellitus, Class A2
• Intervention / Treatment: Drug: Glyburide; Drug: 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 Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glyburide; hypoglycemic agent approved for treatment of GDMA2	Drug: Glyburide; oral hypoglycemic agent
Active Comparator: Metformin; hypoglycemic agent approved for treatment of GDMA2	Drug: Metformin; oral hypoglycemic agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from onset of oral therapy until delivery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Anticipated): June 20, 2017
• Primary Completion (Anticipated): March 10, 2018
• Study Completion (Anticipated): May 10, 2018

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: metformin; gestational diabetes; failure rate; glyburide
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin; Glyburide
• Other Study ID Numbers: HSC-MS-16-1052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No