Placebo Controlled Dose-Response Study of Rivoglitazone in Type 2 Diabetes

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the change 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.

Criteria

Inclusion Criteria:

• type 2 diabetes mellitus

• HbA1c >6.5% and <10%

• FPG >126 mg/dL (7mmol/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

• impaired hepatic function

• CHF or history of CHF (NYHA stage I - IV)

• uncontrolled hypertension