Randomized, Double-Blind Active Comparator-Controlled Study of Rivoglitazone in Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484198
Recruitment Status : Completed
First Posted : June 8, 2007
Last Update Posted : February 3, 2010
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator (Pioglitazone)-controlled, parallel-group study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: pioglitazone Drug: placebo Drug: rivoglitazone HCl Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Study Start Date : April 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1 Drug: placebo

Experimental: 2
Rivoglitazone 1.0 mg
Drug: rivoglitazone HCl

Experimental: 3
Rivoglitazone 1.5 mg
Drug: rivoglitazone HCl

Active Comparator: 4
Pioglitazone 45 mg
Drug: pioglitazone
Other Name: Actos

Primary Outcome Measures :
  1. Glycemic control - HbA1c [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Glycemic control - FPG Responder rates - A1C Effects on lipid parameters [ Time Frame: 26 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of type 2 diabetes
  • Male or female at least 18 years of age
  • A1C > 7% and less or equal to 8.5%
  • Non-fasting C-peptide > 0.5ng/mL
  • Current monotherapy treatment with stable dose of approved non-TZD antihyperglycemic medication for greater or equal to 3 months prior to screening or
  • Untreated with any antihyperglycemic agent during 2 months prior to screening

Exclusion Criteria:

  • History of type 1 diabetes or ketoacidosis
  • History of long-term therapy with insulin
  • BMI > 45 kg/m2
  • Known history of CHF
  • Impaired hepatic function
  • History of prior treatment failure with, or intolerance of, a TZD
  • Contraindication to treatment with pioglitazone
  • Treatment with fibrates
  • If untreated with oral antihyperglycemic, considered to have failed diet and exercise modification as sole treatment for type 2 diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00484198

  Hide Study Locations
United States, Alabama
Anniston, Alabama, United States
Birmingham, Alabama, United States
Hoover, Alabama, United States
Muscle Shoals, Alabama, United States
United States, Arkansas
Hot Springs, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
United States, California
Buena Park, California, United States
Garden Grove, California, United States
Huntington Park, California, United States
Los Angeles, California, United States
Paramount, California, United States
Sacramento, California, United States
San Diego, California, United States
Walnut Creek, California, United States
West Covina, California, United States
West Hills, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Florida
Delray Beach, Florida, United States
Jacksonville, Florida, United States
Merritt Island, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
United States, Hawaii
Honolulu, Hawaii, United States
United States, Idaho
Boise, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
Indianapolis, Indiana, United States
United States, Kansas
Wichita, Kansas, United States
United States, Kentucky
Madisonville, Kentucky, United States
United States, Louisiana
New Orleans, Louisiana, United States
Slidell, Louisiana, United States
United States, Massachusetts
Springfield, Massachusetts, United States
United States, Michigan
Portage, Michigan, United States
Southfield, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New Jersey
Voorhees, New Jersey, United States
United States, New York
Syracuse, New York, United States
United States, North Carolina
Morehead City, North Carolina, United States
Salisbury, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Delaware, Ohio, United States
Lyndhurst, Ohio, United States
Marion, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Beaver, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
Columbia, South Carolina, United States
United States, Tennessee
Cleveland, Tennessee, United States
Kingsport, Tennessee, United States
New Tazewell, Tennessee, United States
United States, Texas
Carrollton, Texas, United States
Conroe, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Garland, Texas, United States
Irving, Texas, United States
Midland, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Richmond, Virginia, United States
United States, Washington
Olympia, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Loma Hermosa, Buenos Aires, Argentina
Zarate, Buenos Aires, Argentina
San Vicente, Cordoba, Argentina
Feldkirch, Austria
Graz, Austria
Wien, Austria
Santiago, Providencia, Chile
Santiago, Chile
Temuco, Chile
Czech Republic
Belsky Les, Czech Republic
Havifov-Mesto, Czech Republic
Karlovy Vary, Czech Republic
Prague, Czech Republic
Praha, Czech Republic
Usti Nad Labem, Czech Republic
Zlin, Czech Republic
Znojmo, Czech Republic
Aschaffenburg, Germany
Augsburg, Germany
Bad Oeynhausen, Germany
Berlin, Germany
Bosenheim, Germany
Dortmund, Germany
Dresden, Germany
Friedrichsthal, Germany
Giessen, Germany
Halle, Germany
Hamburg, Germany
Kippenheim, Germany
Mainz, Germany
Rehlingen, Germany
Riesa, Germany
Saarbrucken, Germany
Saarlouis, Germany
Siegen, Germany
Wiesbaden, Germany
Balatonfured, Hungary
Bekescsaba, Hungary
Budapest, Hungary
Debrecen, Hungary
Eger, Hungary
Gyula, Hungary
Kaposvar, Hungary
Szentes, Hungary
Hyderabad, Andhra Pradesh, India
Vijayawad, Andhra Pradesh, India
Visakhapatnam, Andhra Pradesh, India
Vasanth Nagar, Bangalore, India
Mylapore, Chennai, India
Shastri Nagar, Ghaziabad, India
Ahmedabad, Gujarat, India
Gandhinagar, Gujarat, India
Karnal, Haryana, India
C-Scheme, Jaipur, India
Bangalore, Karnataka, India
Belgaum, Karnataka, India
Mangalore, Karnataka, India
Kochin, Kerala, India
Indore, Madhya Pradesh, India
Dhantoli, Nagpur, India
Ramdaspeth, Nagpur, India
Jaipur, Rajasthan, India
Coimbatore, Tamil Nadu, India
Aligarh, Uttar Pradesh, India
Maharashtra, India
Daugavpils, Latvia
Kuldiga, Latvia
Liepaja, Latvia
Riga, Latvia
Cuernavaca, Morelos, Mexico
Monterrey, Nuevo Leon, Mexico
Metepec, Toluca, Mexico
Merida, Yucatan, Mexico
Aguascalientes, Mexico
Durango, Mexico
Puebla, Mexico
La Victoria, Lima, Peru
Magdalena Del Mar, Lima, Peru
Monterrico Surco, Lima, Peru
San Juan de Miraflores, Lima, Peru
San Martin de Porres, Lima, Peru
Lima, Peru
Puerto Rico
Rio Piedras, Puerto Rico
San Juan, Puerto Rico
Villa Fontana Carolina, Puerto Rico
Arad, Romania
Brasov, Romania
Bucharest, Romania
Satu Mare, Romania
Targu Mures, Romania
Belgrade, Serbia
Kragujevac, Serbia
Nis, Serbia
Subotica, Serbia
Zemun, Serbia
Bratislava, Slovakia
Lucenec, Slovakia
Moldava Nad Bodvou, Slovakia
Nove Mesto Nad Vahom, Slovakia
Pov. Bystrica, Slovakia
Zilina, Slovakia
South Africa
Johannesburg, South Africa
Port Elizabeth, South Africa
Dniepropetrovsk, Ukraine
Kharkov, Ukraine
Kiev, Ukraine
Lviv, Ukraine
Simferopol, Ukraine
United Kingdom
Edmonton, London, United Kingdom
Sunbury, Middlesex, United Kingdom
Addlestone, Surrey, United Kingdom
Wakefield, West Yorks, United Kingdom
Swindon, Wiltshire, United Kingdom
Chippenham, United Kingdom
Sponsors and Collaborators
Daiichi Sankyo, Inc.

Responsible Party: Vice President, Clinical Development, Daiichi Sankyo Identifier: NCT00484198     History of Changes
Other Study ID Numbers: CS0011-A-U301
First Posted: June 8, 2007    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs