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
PHASE2
250 participants
INTERVENTIONAL
2004-05-31
2005-10-31
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
Interventions
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Tesaglitazar
Eligibility Criteria
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Inclusion Criteria
* Men or women who are \>=18 years of age
* Female patients: postmenopausal, hysterectomized
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral anti-diabetic 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
30 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Japan Medical Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Ashino, , Japan
Research Site
Fuchu Keijinkai, , Japan
Research Site
Fujimino, , Japan
Research Site
Hijirino Koike, , Japan
Research Site
Houseikai, , Japan
Research Site
Hyūga, , Japan
Research Site
Iriuchijima, , Japan
Research Site
Iwase, , Japan
Research Site
Katō, , Japan
Research Site
Kawamata, , Japan
Research Site
Keishukai Shirakawa, , Japan
Research Site
Koga, , Japan
Research Site
Kōhoku, , Japan
Research Site
Kōsei, , Japan
Research Site
Kurosawa, , Japan
Research Site
Nihonmatu, , Japan
Research Site
Oki, , Japan
Research Site
Saiseikai Fukuoka, , Japan
Research Site
Sapporo, , Japan
Research Site
Takamori, , Japan
Countries
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Other Identifiers
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SH-SBD-0013
Identifier Type: -
Identifier Source: secondary_id
D6160L00001
Identifier Type: -
Identifier Source: org_study_id
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