drugset / Trial / NCT00316758
A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GK Activator (2) | Unknown | 25 mg | Oral |
| Subject | GK Activator (2) | Unknown | 100 mg | Oral |
| Background | Metformin | Small molecule | — | — |