CompletedPhase 1/2

Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)

United States177 participantsStarted 2011-07

Plain-language summary

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

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Women taking medications expected to interact with glyburide, metformin or alter blood glucose concentrations
✕. Serum creatinine \> 1.2 mg/dL
✕. Hematocrit \< 28%
✕. Allergy to glyburide, metformin or sulfa
✕. Significant hepatic disease
✕. Congestive heart failure or history of MI
✕. Moderate to severe pulmonary disease
✕. Adrenal or pituitary insufficiency

Study drug dosage in pregnancy

Timeframe: Completion of data collection (4-5mnths on average in GDM and healthy pregnant women and max of 6 months in newly diagnosed T2DMs)

NCT IDNCT01329016

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

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2015-02-28