Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

May 6, 2021 updated by: Daiichi Sankyo, Inc.

A Randomized, Double-blind, Double-dummy, Placebo-controlled 26-week Dose-response Study of Rivoglitazone HCl (CS-011) With Active Comparator (Pioglitazone HCl) in Subjects With Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

441

Phase

  • Phase 2
  • Phase 3

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Columbiana, Alabama, United States
      • Huntsville, Alabama, United States
      • Muscle Shoals, Alabama, United States
    • Arkansas
      • Hot Springs, Arkansas, United States
      • Jonesboro, Arkansas, United States
      • Little Rock, Arkansas, United States
      • Searcy, Arkansas, United States
      • Sherwood, Arkansas, United States
    • California
      • Los Angeles, California, United States
      • Moreno Valley, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
      • San Mateo, California, United States
      • Santa Monica, California, United States
      • Torrance, California, United States
      • Vista, California, United States
      • West Hills, California, United States
    • Delaware
      • Newark, Delaware, United States
    • Florida
      • Clearwater, Florida, United States
      • Cocoa Beach, Florida, United States
      • Jupiter, Florida, United States
      • Largo, Florida, United States
      • Miami, Florida, United States
      • New Port Richey, Florida, United States
      • Palm Harbor, Florida, United States
      • Pembroke Pines, Florida, United States
      • Tampa, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Warner Robins, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Gurnee, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Michigan
      • Detroit, Michigan, United States
      • Livonia, Michigan, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Montana
      • Bozeman, Montana, United States
      • Butte, Montana, United States
      • Great Falls, Montana, United States
    • New Jersey
      • Voorhees, New Jersey, United States
    • New York
      • Rochester, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Statesville, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Marion, Ohio, United States
    • Oklahoma
      • Clinton, Oklahoma, United States
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Simpsonville, South Carolina, United States
    • Tennessee
      • Bristol, Tennessee, United States
    • Texas
      • Carrollton, Texas, United States
      • Conroe, Texas, United States
      • Houston, Texas, United States
      • Midland, Texas, United States
      • San Antonio, Texas, United States
      • Spring, Texas, United States
      • Sugar Land, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Lakewood, Washington, United States
      • Olympia, Washington, United States
      • Renton, Washington, United States
      • Spokane, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in HbA1c

Secondary Outcome Measures

Outcome Measure
FPG, Lipids, hsCRP, Adiponectin

Collaborators and Investigators

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

Sponsor

Daiichi Sankyo, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS0011-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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