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
580 participants
INTERVENTIONAL
2004-09-30
2006-12-31
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
Glibenclamide
Eligibility Criteria
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Inclusion Criteria
* Men or women who are \>=18 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
Antwerp, , Belgium
Research Site
Braine-l'Alleud, , Belgium
Research Site
Hasselt, , Belgium
Research Site
Liège, , Belgium
Research Site
Merksem, , Belgium
Research Site
Sint-Gillis-Waas, , Belgium
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Steenokkerzeel, , Belgium
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Shatin, N.T., , Hong Kong
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Kaposvár, , Hungary
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Kecskemét, , Hungary
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Székesfehérvár, , Hungary
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Arenzano, , Italy
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Chiavari (GE), , Italy
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Chieri, , Italy
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Gubbio (PG), , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Perugia, , Italy
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Piacenza, , Italy
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Reggio Calabria, , Italy
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Reggio Emilia, , Italy
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Rho, , Italy
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Roma, , Italy
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Udine, , Italy
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Kubang Kerian, Kota Bharu, Malaysia
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Kuala Lampur, , Malaysia
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México, D.F., Mexico
Research Site
Guadalajara, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
Research Site
Veracruz, , Mexico
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Ås, , Norway
Research Site
Bergen, , Norway
Research Site
Kongsvinger, , Norway
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Lysaker, , Norway
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Oslo, , Norway
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Skedsmokorset, , Norway
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Sørumstand, , Norway
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Trondheim, , Norway
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Manila, , Philippines
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Pasig, , Philippines
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Krakow, , Poland
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Lublin, , Poland
Research Site
P³ock, , Poland
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Toruñ, , Poland
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Tychy, , Poland
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Warsaw, , Poland
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£ód?, , Poland
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Bratislava, , Slovakia
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Ilava, , Slovakia
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Košice, , Slovakia
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Kysucké Nové Mesto, , Slovakia
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Lučenec, , Slovakia
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Ľubochňa, , Slovakia
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Nitra, , Slovakia
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Prešov, , Slovakia
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Trnava, , Slovakia
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Cape Town, , South Africa
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Durban, , South Africa
Research Site
Houghton Gauteng, , South Africa
Research Site
Changhua, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Bangkok, , Thailand
Countries
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Other Identifiers
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D6160C00028
Identifier Type: -
Identifier Source: org_study_id
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