Glyburide and Metformin for Gestational Diabetes Mellitus (GDM) — GDM  

Gestational Diabetes Mellitus Clinical Trial

Official title: Glyburide and Metformin for Gestational Diabetes Mellitus

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial Description

Gestational diabetes mellitus (GDM) is a common complication of pregnancy. Multiple treatment regimens are currently used for the management of GDM. Following failure of diet therapy, insulin, glyburide and metformin are all used in the treatment of GDM with the oral medications providing comparable outcomes with insulin but easier route of administration and schedule. The proposed work will evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of glyburide and metformin alone and in combination in order to lay the foundation in establishing dosage and response information that could be utilized in designing a phase III randomized trial that will ultimately evaluate GDM treatment optimization. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

• NCT number: NCT01329016
• Study type: Interventional
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2011
• Completion date: June 2015