Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• Type 2 diabetes in male or female patients

• Between 18 and 75 years of age

• With a HbA1c greater than or equal to 7.5% and less than 10.5% at randomization

Exclusion Criteria:

• Type 1 diabetics or type 2 diabetics currently on insulin therapy

• Patients unwilling or unable to discontinue their anti-diabetic medication(s)

• History of ketoacidosis

• History of therapy with rosiglitazone, troglitazone, pioglitazone