Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT00143520
• Lead Sponsor: Daiichi Sankyo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in HbA1c

Secondary Outcome Measures

Name	Time	Method
FPG, Lipids, hsCRP, Adiponectin