Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

Phase 2/3 Completed 441 enrolled Daiichi Sankyo

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not adequately treated with other antidiabetic agents. The study tests rivoglitazone and uses a placebo and active treatment group for comparison.

Timeline

Start: 2004-12
Primary completion: 2005-12
Completion: 2005-12

Outcome

Met primary endpoint

paper more effective than placebo in reducing HbA(1c) from baseline to week 26 PMID 20370378 ↗

paper -0.55% [p = 0.0034] PMID 20370378 ↗

Publications

Truitt KE, Goldberg RB, Rosenstock J, Chou HS, Merante D, Triscari J, Wang AC. A 26-week, placebo- and pioglitazone-controlled, dose-ranging study of rivoglitazone, a novel thiazolidinedione for the treatment of type 2 diabetes. Curr Med Res Opin. 2010 Jun;26(6):1321-31. doi: 10.1185/03007991003715079.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pioglitazone	Small molecule	45 mg	—
Subject	Rivoglitazone	Small molecule	1 mg	—
Subject	Rivoglitazone	Small molecule	2 mg	—
Subject	Rivoglitazone	Small molecule	3 mg	—