drugset / Trial / NCT00366379
A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of \<100mg/dL. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Timeline
- Start
- 2006-07
- Primary completion
- 2007-06
- Completion
- 2007-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GK Activator (2) | Unknown | 25 mg | Oral |
| Subject | GK Activator (2) | Unknown | 200 mg | Oral |