Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

NCT ID: NCT00143520

Last Updated: 2021-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

441 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2005-12-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Rivoglitazone

Intervention Type DRUG

Pioglitazone

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Daiichi Sankyo

Locations

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Birmingham, Alabama, United States

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Columbiana, Alabama, United States

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Huntsville, Alabama, United States

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Muscle Shoals, Alabama, United States

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Hot Springs, Arkansas, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Searcy, Arkansas, United States

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Sherwood, Arkansas, United States

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Los Angeles, California, United States

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Moreno Valley, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Mateo, California, United States

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Santa Monica, California, United States

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Torrance, California, United States

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Vista, California, United States

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West Hills, California, United States

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Newark, Delaware, United States

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Clearwater, Florida, United States

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Cocoa Beach, Florida, United States

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Jupiter, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Palm Harbor, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Warner Robins, Georgia, United States

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Chicago, Illinois, United States

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Gurnee, Illinois, United States

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Evansville, Indiana, United States

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Lexington, Kentucky, United States

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New Orleans, Louisiana, United States

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Detroit, Michigan, United States

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Livonia, Michigan, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Bozeman, Montana, United States

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Butte, Montana, United States

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Great Falls, Montana, United States

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Voorhees Township, New Jersey, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Statesville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Marion, Ohio, United States

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Clinton, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Medford, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Simpsonville, South Carolina, United States

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Bristol, Tennessee, United States

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Carrollton, Texas, United States

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Conroe, Texas, United States

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Houston, Texas, United States

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Midland, Texas, United States

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San Antonio, Texas, United States

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Spring, Texas, United States

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Sugar Land, Texas, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Lakewood, Washington, United States

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Olympia, Washington, United States

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Renton, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20370378 (View on PubMed)

Other Identifiers

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CS0011-203

Identifier Type: -

Identifier Source: org_study_id

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