drugset / Trial / NCT00266253

A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin

NCT00266253

Phase 2 Completed 220 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.

Timeline

Start
2005-11
Primary completion
2007-03
Completion
2007-03

Drugs

EvaluationDrugModalityDoseRoute
Subject GK Activator (2) Unknown Oral
Background Metformin Small molecule