drugset / Trial / NCT00316758

A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.

NCT00316758

Phase 2 Completed 259 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Timeline

Start
2006-02
Primary completion
2007-10
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject GK Activator (2) Unknown 25 mg Oral
Subject GK Activator (2) Unknown 100 mg Oral
Background Metformin Small molecule