Study Results
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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TERMINATED
PHASE3
1450 participants
INTERVENTIONAL
2004-08-31
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Galida
Eligibility Criteria
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Inclusion Criteria
* Men or women who are ³18 years of age
* Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
Exclusion Criteria
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Received any investigational product in other clinical studies within 12 weeks
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Galida Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Altoona, Pennsylvania, United States
Research Site
Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Moron- Buenos Aires, , Argentina
Research Sites
Quilmes - Buenos Aires, , Argentina
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Rosario, , Argentina
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Salta, , Argentina
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Curitiba, , Brazil
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Edmonton, Alberta, Canada
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Abbotsford, British Columbia, Canada
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Chilliwack, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Dartmouth, Nova Scotia, Canada
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Halifax, Nova Scotia, Canada
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Truro, Nova Scotia, Canada
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Windsor, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Etobicoke, Ontario, Canada
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Kingston, Ontario, Canada
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Niagara Falls, Ontario, Canada
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Oshawa, Ontario, Canada
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Scarborough Village, Ontario, Canada
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St. Catharines, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Trois-Rivières, Quebec, Canada
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Chicoutimi, , Canada
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Longueuil, , Canada
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Montreal, , Canada
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St. John's, , Canada
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Espoo, , Finland
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Helsinki, , Finland
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Kuopio, , Finland
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Pietarsaar, , Finland
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Pori, , Finland
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Tampere, , Finland
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Guadalajara Jalisco, , Mexico
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Mexico City, , Mexico
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México, , Mexico
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Nuevo León, , Mexico
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Puebla City, , Mexico
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Torreón, , Mexico
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Zapopan, , Mexico
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Ås, , Norway
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Bergen, , Norway
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Elvernum, , Norway
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Hamar, , Norway
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Horten, , Norway
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Kongsberg, , Norway
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Lena, , Norway
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Loeten, , Norway
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Lysaker, , Norway
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Oslo, , Norway
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Osteraas, , Norway
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Skedsmokorset, , Norway
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Straume, , Norway
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Tronheim, , Norway
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Tønsberg, , Norway
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Dublin, Ireland, United Kingdom
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Wexford, Ireland, United Kingdom
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Antrim, NI, United Kingdom
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Belfast, , United Kingdom
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Cardiff, , United Kingdom
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Edinburgh, , United Kingdom
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Glasgow, , United Kingdom
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Kent, , United Kingdom
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Leeds, , United Kingdom
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Mid Glamorgan, , United Kingdom
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Pembrokeshire, , United Kingdom
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Plymouth, , United Kingdom
Research SIte
Reading, , United Kingdom
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Surrey, , United Kingdom
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Wiltshire, , United Kingdom
Countries
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Other Identifiers
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D6160C00030
Identifier Type: -
Identifier Source: org_study_id