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COMPLETED
NCT01329016
PHASE1/PHASE2

Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)

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

View on ClinicalTrials.gov

Summary

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

Official title: Glyburide and Metformin for Gestational Diabetes Mellitus

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

177

Start Date

2011-07

Completion Date

2015-02-28

Last Updated

2026-05-11

Healthy Volunteers

Yes

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.

Locations (4)

Indiana University School of Medicine

Indianapolis, Indiana, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Texas Medical Branch

Galveston, Texas, United States

University of Washington

Seattle, Washington, United States