drugset / Trial / NCT00571519
Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator-controlled, parallel-group study in participants with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. Pioglitazone is used as active comparator. The total duration of a participant's participation will be approximately 30 weeks, including a 2-week placebo lead-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period. Participants who complete the randomized portion of the study per protocol may have the opportunity to continue in a long-term extension study of active treatments.
Timeline
- Start
- 2007-11-14
- Primary completion
- 2008-05-23
- Completion
- 2008-05-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pioglitazone | Small molecule | 15 mg | Oral |
| Comparator | Pioglitazone | Small molecule | 30 mg | Oral |
| Comparator | Pioglitazone | Small molecule | 45 mg | Oral |
| Subject | Rivoglitazone | Small molecule | 0.5 mg | Oral |
| Subject | Rivoglitazone | Small molecule | 1 mg | Oral |
| Subject | Rivoglitazone | Small molecule | 1.5 mg | Oral |
| Background | Metformin | Small molecule | — | Oral |