drugset / Trial / NCT00571519

Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus

NCT00571519

Phase 3 Terminated 94 enrolled Daiichi Sankyo
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

EvaluationDrugModalityDoseRoute
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