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Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)

NCT01329016 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2026-05-11

No results posted yet for this study

Summary

This is a pharmacokinetic and pharmacodynamic study evaluating glyburide, metformin, and combination treatment for gestational diabetes mellitus.

Conditions

  • Gestational Diabetes Mellitus

Interventions

DRUG

Glyburide

Women with GDM who require treatment will be given glyburide 2.5 mg. Medication will be given at least twice daily and equal doses will be given for each dosing time for the 3 days prior to the pharmacokinetic study day.

DRUG

Metformin

Women with GDM requiring treatment will be given metformin 500 mg. Medication will be administered at least twice daily and equal doses will be given for each dosing time for the 3 days prior to the pharmacokinetic study day.

DRUG

Glyburide-Metformin combination

Women with GDM requiring treatment will be given glyburide 2.5 mg with metformin 500 mg. Medications will be administered at least twice daily and equal doses will be given for each dosing time 3 days prior to the pharmacokinetic study day.

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • Indiana University

    collaborator OTHER

  • RTI International

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Mary F. Hebert, PharmD, FCCP · University of Washington

  • Steve Caritis, MD · University of Pittsburgh

  • Gary DV Hankins, MD · University of Texas

  • David Flockhart, MD, PhD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01329016 on ClinicalTrials.gov