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Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rivoglitazone
Pioglitazone
Placebo
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Placebo and active control dose response study of rivoglitazone in type 2 diabetics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Change in HbA1c

Secondary Outcome Measures

FPG, Lipids, hsCRP, Adiponectin

Full Information

First Posted
September 1, 2005
Last Updated
May 6, 2021
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00143520
Brief Title
Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Placebo and active control dose response study of rivoglitazone in type 2 diabetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
441 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rivoglitazone
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in HbA1c
Secondary Outcome Measure Information:
Title
FPG, Lipids, hsCRP, Adiponectin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Columbiana
State/Province
Alabama
Country
United States
City
Huntsville
State/Province
Alabama
Country
United States
City
Muscle Shoals
State/Province
Alabama
Country
United States
City
Hot Springs
State/Province
Arkansas
Country
United States
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Jonesboro
State/Province
Arkansas
Country
United States
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Little Rock
State/Province
Arkansas
Country
United States
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Searcy
State/Province
Arkansas
Country
United States
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Sherwood
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Arkansas
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United States
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Los Angeles
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California
Country
United States
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Moreno Valley
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California
Country
United States
City
Sacramento
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California
Country
United States
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San Diego
State/Province
California
Country
United States
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San Mateo
State/Province
California
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United States
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Santa Monica
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California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Vista
State/Province
California
Country
United States
City
West Hills
State/Province
California
Country
United States
City
Newark
State/Province
Delaware
Country
United States
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Clearwater
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Florida
Country
United States
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Cocoa Beach
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Florida
Country
United States
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Jupiter
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Florida
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United States
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Largo
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Florida
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United States
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Miami
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Florida
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United States
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New Port Richey
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Florida
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United States
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Palm Harbor
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Florida
Country
United States
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Pembroke Pines
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Florida
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United States
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Tampa
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Florida
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United States
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West Palm Beach
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Florida
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United States
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Warner Robins
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Georgia
Country
United States
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Chicago
State/Province
Illinois
Country
United States
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Gurnee
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Illinois
Country
United States
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Evansville
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Indiana
Country
United States
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Lexington
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Kentucky
Country
United States
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New Orleans
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Louisiana
Country
United States
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Detroit
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Michigan
Country
United States
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Livonia
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Michigan
Country
United States
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Kansas City
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Missouri
Country
United States
City
Saint Louis
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Missouri
Country
United States
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Bozeman
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Montana
Country
United States
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Butte
State/Province
Montana
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United States
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Great Falls
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Montana
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United States
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Voorhees
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New Jersey
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United States
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Rochester
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New York
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United States
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Charlotte
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North Carolina
Country
United States
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Statesville
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North Carolina
Country
United States
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Winston-Salem
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North Carolina
Country
United States
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Cincinnati
State/Province
Ohio
Country
United States
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Columbus
State/Province
Ohio
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United States
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Marion
State/Province
Ohio
Country
United States
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Clinton
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Oklahoma
Country
United States
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Oklahoma City
State/Province
Oklahoma
Country
United States
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Tulsa
State/Province
Oklahoma
Country
United States
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Medford
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Oregon
Country
United States
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Philadelphia
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Pennsylvania
Country
United States
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Pittsburgh
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Pennsylvania
Country
United States
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Charleston
State/Province
South Carolina
Country
United States
City
Simpsonville
State/Province
South Carolina
Country
United States
City
Bristol
State/Province
Tennessee
Country
United States
City
Carrollton
State/Province
Texas
Country
United States
City
Conroe
State/Province
Texas
Country
United States
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Houston
State/Province
Texas
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United States
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Midland
State/Province
Texas
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United States
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San Antonio
State/Province
Texas
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United States
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Spring
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Texas
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United States
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Sugar Land
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Texas
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United States
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Norfolk
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Virginia
Country
United States
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Richmond
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Virginia
Country
United States
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Virginia Beach
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Virginia
Country
United States
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Lakewood
State/Province
Washington
Country
United States
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Olympia
State/Province
Washington
Country
United States
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Renton
State/Province
Washington
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20370378
Citation
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.
Results Reference
derived

Learn more about this trial

Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

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