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

February 27, 2009 updated by: Daiichi Sankyo Co., Ltd.

A Randomized, Double-Blind, Placebo-Controlled 12-Week Dose-Response Study of Rivoglitazone (CS-011) in Patients With Type 2 Diabetes.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
      • Osaka, Japan
      • Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
rivoglitazone HCl 0.5 mg tablets once daily for 12 weeks
Drug: Rivoglitazone HCl
0.5 mg tablets once daily for 12 weeks
Experimental: 2
rivoglitazone HCl 1 mg tablets once daily for 12 weeks
Drug: rivoglitazone HCl
1.0 mg tablets once daily for 12 weeks
Drug: rivoglitazone HCl
1.5 mg tablets once daily for 12 weeks
Experimental: 3
rivoglitazone HCl 1.5 mg tablets once daily for 12 weeks
Drug: rivoglitazone HCl
1.0 mg tablets once daily for 12 weeks
Drug: rivoglitazone HCl
1.5 mg tablets once daily for 12 weeks
Placebo Comparator: 4
Matching placebo tablets once daily for 12 weeks
Drug: Placebo
Matching placebo tablets once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c from baseline for rivoglitazone compared to placebo
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to placebo
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

March 2, 2009

Last Update Submitted That Met QC Criteria

February 27, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS011-A-J204

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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