Study of Rivoglitazone in Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2009-02-12
• Target enrollment: 0
• Participant gender: All

Summary

This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of type 2 diabetes

• Male or female at least 18 years of age

• Hemoglobin A1C > 7% and less or equal to 8.5%

• Non-fasting C-peptide > 0.5 ng/mL

• Current monotherapy treatment with stable dose of approved non-Thiazolidinedione (TZD) antihyperglycemic medication for greater or equal to 3 months prior to screening or

• Untreated with any antihyperglycemic agent during 2 months prior to screening

Exclusion Criteria:

• History of type 1 diabetes or ketoacidosis

• History of long-term therapy with insulin

• Body Mass Index (BMI) > 45 kg/m^2

• Known history of Congestive Heart Failure (CHF)

• Impaired hepatic function

• History of prior treatment failure with, or intolerance of, a TZD

• Contraindication to treatment with pioglitazone

• Treatment with fibrates

• If untreated with oral antihyperglycemic, considered to have failed diet and exercise modification as the sole treatment for type 2 diabetes