Failure Rate of GLyburide And Metformin Among Gestational Diabetics

NCT03078725 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: HSC-MS-16-1052
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A pragmatic, comparative effectiveness trial of glyburide versus metformin.

Conditions

Gestational Diabetes Mellitus, Class A2

Keywords

gestational diabetes; glyburide; metformin; failure rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Mean overall plasma glucose

  from enrollment to delivery

• Mean weekly fasting glucose

  from enrollment to delivery

• preeclampsia

  from enrollment to delivery

• cesarean section

  from enrollment to delivery

• neonatal hypoglycemia

  from enrollment to delivery

Study Arms (2)

Glyburide

ACTIVE COMPARATOR

hypoglycemic agent approved for treatment of GDMA2

Drug: Glyburide

Metformin

ACTIVE COMPARATOR

hypoglycemic agent approved for treatment of GDMA2

Drug: Metformin

Interventions

Glyburide DRUG

oral hypoglycemic agent

Glyburide

Metformin DRUG

oral hypoglycemic agent

Metformin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• We will include women between 20 and 34 weeks gestational age, with a diagnosis of GDM as per the following criteria:
• 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

You may not qualify if:

• \- Known renal impairment.
• Known hepatic disease.
• Pre-gestational diabetes.
• Known allergy to glyburide, metformin or sulfa drugs.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glyburide; Metformin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Biguanides; Guanidines; Amidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

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

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 13, 2017
• Study Start: June 20, 2017
• Primary Completion: March 10, 2018
• Study Completion: May 10, 2018
• Last Updated: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share