Clinical trial NCT00143520: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Keywords: Placebo and active control dose response study of rivoglitazone in type 2 diabetics
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in HbA1c
Secondary outcomes:
measure: FPG, Lipids, hsCRP, Adiponectin
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Columbiana
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Muscle Shoals
country: United States
state: Alabama
city: Hot Springs
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Searcy
country: United States
state: Arkansas
city: Sherwood
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Moreno Valley
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Mateo
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Torrance
country: United States
state: California
city: Vista
country: United States
state: California
city: West Hills
country: United States
state: California
city: Newark
country: United States
state: Delaware
city: Clearwater
country: United States
state: Florida
city: Cocoa Beach
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Warner Robins
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Gurnee
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: Livonia
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Bozeman
country: United States
state: Montana
city: Butte
country: United States
state: Montana
city: Great Falls
country: United States
state: Montana
city: Voorhees
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Clinton
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Carrollton
country: United States
state: Texas
city: Conroe
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Spring
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Lakewood
country: United States
state: Washington
city: Olympia
country: United States
state: Washington
city: Renton
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
References:
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.