Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

Daiichi Sankyo

Status and phase: Completed; Phase 3; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Pioglitazone; Drug: Rivoglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00143520

CS0011-203

Details and patient eligibility

About

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.

Enrollment: 441 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind