drugset / Trial / NCT00800176
A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus
RandomizedParallel-groupDouble-blindTreatment
Summary
This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take their usual dose of metformin throughout the study.The anticipated time on study treatment is \<=3 months
Timeline
- Start
- 2009-01-22
- Primary completion
- 2009-10-28
- Completion
- 2009-10-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TOFOGLIFLOZIN ANHYDROUS | Other / unclassified | 2.5 mg | Oral |
| Subject | TOFOGLIFLOZIN ANHYDROUS | Other / unclassified | 5 mg | Oral |
| Subject | TOFOGLIFLOZIN ANHYDROUS | Other / unclassified | 10 mg | Oral |
| Subject | TOFOGLIFLOZIN ANHYDROUS | Other / unclassified | 20 mg | Oral |
| Subject | TOFOGLIFLOZIN ANHYDROUS | Other / unclassified | 40 mg | Oral |