NCT00571519

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

A Randomized, Double-blind, Placebo, and Active Comparator-controlled, Parallel-group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Rivoglitazone HCl	0.5 mg tablets administered orally, once daily
DRUG	rivoglitazone HCl	1.0 mg tablets administered orally, once daily
DRUG	rivoglitazone HCl	1.5 mg tablets administered orally, once daily
DRUG	placebo	placebo tablets matching rivoglitazone tablets administered orally, once daily
DRUG	pioglitazone HCl	15 mg capsules administered orally, once daily
DRUG	pioglitazone HCl	30 mg capsules administered orally, once daily
DRUG	pioglitazone HCl 45 mg	45 mg capsules administered orally, once daily
DRUG	placebo	placebo capsules for pioglitazone administered orally, once daily
DRUG	metformin	Oral tablets. Rescue medication.

Timeline

• Start date: 2007-11-14
• Primary completion: 2008-05-23
• Completion: 2008-05-23
• First posted: 2007-12-12
• Last updated: 2021-05-26
• Results posted: 2021-02-26

Locations

18 sites across 1 country: United States