Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1912 participants
INTERVENTIONAL
2007-04-23
2009-02-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Placebo
Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule
2
Rivoglitazone 1.0 mg
Rivoglitazone
1.0 mg tablet administered orally, once daily
3
Rivoglitazone 1.5 mg
Rivoglitazone
1.5 mg tablet administered orally, once daily
4
Pioglitazone 45 mg
Pioglitazone
45 mg over-encapsulated tablet administered orally, once daily
Interventions
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Pioglitazone
45 mg over-encapsulated tablet administered orally, once daily
Placebo
Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule
Rivoglitazone
1.0 mg tablet administered orally, once daily
Rivoglitazone
1.5 mg tablet administered orally, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female at least 18 years of age
* Hemoglobin A1C \> 7% and less or equal to 8.5%
* Non-fasting C-peptide \> 0.5 ng/mL
* Current monotherapy treatment with stable dose of approved non-Thiazolidinedione (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 long-term therapy with insulin
* Body Mass Index (BMI) \> 45 kg/m\^2
* Known history of Congestive Heart Failure (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 the sole treatment for type 2 diabetes
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Anniston, Alabama, United States
Birmingham, Alabama, United States
Hoover, Alabama, United States
Muscle Shoals, Alabama, United States
Hot Springs, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
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
Denver, Colorado, United States
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
Honolulu, Hawaii, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Madisonville, Kentucky, United States
New Orleans, Louisiana, United States
Slidell, Louisiana, United States
Springfield, Massachusetts, United States
Portage, Michigan, United States
Southfield, Michigan, United States
St Louis, Missouri, United States
Voorhees Township, New Jersey, United States
Syracuse, New York, United States
Morehead City, North Carolina, United States
Salisbury, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Delaware, Ohio, United States
Lyndhurst, Ohio, United States
Marion, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Beaver, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Cleveland, Tennessee, United States
Kingsport, Tennessee, United States
New Tazewell, Tennessee, United States
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
Richmond, Virginia, United States
Olympia, Washington, United States
Milwaukee, Wisconsin, United States
Loma Verde, Buenos Aires, Argentina
Zárate, Buenos Aires, Argentina
San Vicente, Córdoba Province, Argentina
Feldkirch, , Austria
Graz, , Austria
Vienna, , Austria
Santiago, Providencia, Chile
Santiago, , Chile
Temuco, , Chile
Horní Město, , Czechia
Karlovy Vary, , Czechia
Prague, , Czechia
Ústí nad Labem, , Czechia
Vysoký Les, , Czechia
Zlín, , Czechia
Znojmo, , Czechia
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
Saarbrücken, , Germany
Saarlouis, , Germany
Siegen, , Germany
Wiesbaden, , Germany
Balatonfüred, , Hungary
Békéscsaba, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Eger, , Hungary
Gyula, , Hungary
Kaposvár, , Hungary
Szentes, , Hungary
Hyderabad, Andhra Pradesh, India
Vijayawada, Andhra Pradesh, India
Visakhapatnam, Andhra Pradesh, India
Vasanth Nagar, Bangalore, India
Mylapore, Chennai, India
Shāstri Nagar, Ghaziabad, India
Ahmedabad, Gujarat, India
Gandhinagar, Gujarat, India
Karnāl, Haryana, India
Sarwa C., Jaipur, India
Bangalore, Karnataka, India
Belagavi, Karnataka, India
Mangalore, Karnataka, India
Kochi, Kerala, India
Indore, Madhya Pradesh, India
Mumbai, Maharashtra, India
Dhantoli, Nagpur, India
Rāmdaspeth, Nagpur, India
Jaipur, Rajasthan, India
Coimbatore, Tamil Nadu, India
Aligarh, Uttar Pradesh, India
Daugavpils, , Latvia
Kuldīga, , Latvia
Liepāja, , Latvia
Riga, , Latvia
Cuernavaca, Morelos, Mexico
Monterrey, Nuevo León, Mexico
Metepec, Toluca, Mexico
Mérida, Yucatán, Mexico
Aguascalientes, , Mexico
Durango, , Mexico
Puebla City, , Mexico
La Victoria, Lima region, Peru
Magdalena del Mar, Lima region, Peru
San Juan de Miraflores, Lima region, Peru
San Martín de Porres, Lima region, Peru
Monterrico, Sucro Lima, Peru
Lima, , Peru
Villa Fontana, Carolina, Puerto Rico
Rio Piedras, , Puerto Rico
San Juan, , Puerto Rico
Arad, , Romania
Brasov, , Romania
Bucharest, , Romania
Satu Mare, , Romania
Târgu Mureş, , Romania
Belgrade, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Subotica, , Serbia
Zemun, , Serbia
Bratislava, , Slovakia
Lučenec, , Slovakia
Moldava nad Bodvou, , Slovakia
Nové Mesto nad Váhom, , Slovakia
Považská Bystrica, , Slovakia
Žilina, , Slovakia
Johannesburg, , South Africa
Port Elizabeth, , South Africa
Dnipro, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Simferopol, , Ukraine
Edmonton, London, United Kingdom
Sunbury-on-Thames, Middlesex, United Kingdom
Addlestone, Surrey, United Kingdom
Wakefield, West Yorks, United Kingdom
Swindon, Wiltshire, United Kingdom
Chippenham, , United Kingdom
Countries
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Other Identifiers
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2006-005047-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CS0011-A-U301
Identifier Type: -
Identifier Source: org_study_id
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