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Type 2 DiabetesPhase 2/3NCT00143520

Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

A Phase 2/3 study testing Rivoglitazone and Pioglitazone in people with Type 2 Diabetes, run by Daiichi Sankyo at 74 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Rivoglitazone and Pioglitazone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
441 participants
Where
74 sitesUnited States
Study dates
Dec 2004to Dec 2005
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

74 sites in 1 country.

74 sites in 1 country

United States74 sites

  • Study site

    Birmingham, Alabama

  • Study site

    Bozeman, Montana

  • Study site

    Bristol, Tennessee

  • Study site

    Butte, Montana

  • Study site

    Carrollton, Texas

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Clinton, Oklahoma

  • Study site

    Cocoa Beach, Florida

  • Study site

    Columbiana, Alabama

  • Study site

    Columbus, Ohio

  • Study site

    Conroe, Texas

  • Study site

    Detroit, Michigan

  • Study site

    Evansville, Indiana

  • Study site

    Great Falls, Montana

  • Study site

    Gurnee, Illinois

  • Study site

    Hot Springs, Arkansas

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Jonesboro, Arkansas

  • Study site

    Jupiter, Florida

  • Study site

    Kansas City, Missouri

  • Study site

    Lakewood, Washington

  • Study site

    Largo, Florida

  • Study site

    Lexington, Kentucky

  • Study site

    Little Rock, Arkansas

  • Study site

    Livonia, Michigan

  • Study site

    Los Angeles, California

  • Study site

    Marion, Ohio

  • Study site

    Medford, Oregon

  • Study site

    Miami, Florida

  • Study site

    Midland, Texas

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Moreno Valley, California

  • Study site

    Muscle Shoals, Alabama

  • Study site

    New Orleans, Louisiana

  • Study site

    New Port Richey, Florida

  • Study site

    Newark, Delaware

  • Study site

    Norfolk, Virginia

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Olympia, Washington

  • Study site

    Palm Harbor, Florida

  • Study site

    Pembroke Pines, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Renton, Washington

  • Study site

    Richmond, Virginia

  • Study site

    Rochester, New York

  • Study site

    Sacramento, California

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Mateo, California

  • Study site

    Santa Monica, California

  • Study site

    Searcy, Arkansas

  • Study site

    Sherwood, Arkansas

  • Study site

    Simpsonville, South Carolina

  • Study site

    Spokane, Washington

  • Study site

    Spring, Texas

  • Study site

    St Louis, Missouri

  • Study site

    Statesville, North Carolina

  • Study site

    Sugar Land, Texas

  • Study site

    Tampa, Florida

  • Study site

    Torrance, California

  • Study site

    Tulsa, Oklahoma

  • Study site

    Virginia Beach, Virginia

  • Study site

    Vista, California

  • Study site

    Voorhees Township, New Jersey

  • Study site

    Warner Robins, Georgia

  • Study site

    West Hills, California

  • Study site

    West Palm Beach, Florida

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: 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.

Conditions
Type 2 Diabetes
Being tested
Rivoglitazone, Pioglitazone, Placebo
Keywords
Placebo and active control dose response study of rivoglitazone in type 2 diabetics
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

Secondary outcomes (1)

  1. FPG, Lipids, hsCRP, Adiponectin

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionDec 2005
  4. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
441 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00143520
Sponsor's protocol ID
CS0011-203
Status last verified
May 2021
First submitted
1 Sep 2005
Last updated
10 May 2021
Results posted
No
Individual data sharing
No

Publications

  • Truitt KE, Goldberg RB, Rosenstock J, Chou HS, Merante D, Triscari J, Wang AC. A 26-week, placebo- and pioglitazone-controlled, dose-ranging study of rivoglitazone, a novel thiazolidinedione for the treatment of type 2 diabetes. Curr Med Res Opin. 2010 Jun;26(6):1321-31. doi: 10.1185/03007991003715079.

    PubMed 20370378

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Rivoglitazone and Pioglitazone in people with Type 2 Diabetes, run by Daiichi Sankyo at 74 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00143520, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.

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