Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 Diabetes

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the efficacy response of rivoglitazone HCl compared to pioglitazone HCl on the placebo-corrected change from baseline in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• type 2 diabetes

• HbA1c >6.5% and <10.0%

• FPG >126 mg/dL (7 mmol/L) and < 270 mg/dL (15 mmol/L)

Exclusion Criteria:

• History of type 1 diabetes

• History of ketoacidosis

• Current insulin therapy

• C-peptide <0.5ng/mL

• Imparied hepatic function

• NYHA Class II-IV cardiac status or hospitalization for CHF or EF<40%

• uncontrolled hypertension