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
475 participants
INTERVENTIONAL
2005-04-30
2006-12-31
Brief Summary
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The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT 2 will be transferred to the GALLANT 22 database and will be analyzed together with the data from GALLANT 22 clinical study.
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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
Dietary and Lifestyle counseling
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
* Drug-naïve (ie, no use of antidiabetic drug\[s\], for at least 24 weeks prior to visit 1).
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
Adelaide, , Australia
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Cairns, , Australia
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Gosford, , Australia
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Keswick, , Australia
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Kippa-Ring, , Australia
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Melbourne, , Australia
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Miranda, , Australia
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Nowra, , Australia
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Wollongong, , Australia
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Brno, , Czechia
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Hodonín, , Czechia
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Hradec Králové, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Příbram, , Czechia
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Semily, , Czechia
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Tábor, , Czechia
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Ústí nad Labem, , Czechia
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Paide, , Estonia
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Pärnu, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Viljandi, , Estonia
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Angers, , France
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Briollay, , France
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Poitiers, , France
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Saint-Benoît, , France
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Saint-Ouen, , France
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Toulouse, , France
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Trélazé, , France
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Athens, , Greece
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Piraeus, , Greece
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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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Daugavpils, , Latvia
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Jēkabpils, , Latvia
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Madona, , Latvia
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Riga, , Latvia
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Sigulda, , Latvia
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Talsi, , Latvia
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Valmiera, , Latvia
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Panevezys, , Lithuania
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Vilnius, , Lithuania
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Aursmoen, , Norway
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Bergen, , Norway
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Enebakk, , Norway
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Fredrikstad, , Norway
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Haugesund, , Norway
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Hønefoss, , Norway
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Inderøy, , Norway
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Larvik, , Norway
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Lierskogen, , Norway
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Oslo, , Norway
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Rolvsøy, , Norway
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Cebu City, , Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Katowice, Ochojec, Poland
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Radom, , Poland
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Rzeszów, , Poland
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Sopot, , Poland
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Szczecin, , Poland
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Toruñ, , Poland
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Tychy, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Zielona Góra, , Poland
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Belgrade, , Serbia and Montenegro
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Dolný Kubín, , Slovakia
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Levice, , Slovakia
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Lučenec, , Slovakia
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Ľubochňa, , Slovakia
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Nové Zámky, , Slovakia
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Považská Bystrica, , Slovakia
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Šahy, , Slovakia
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Trenčín, , Slovakia
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Veľký Meder, , Slovakia
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Žilina, , Slovakia
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Åmål, , Sweden
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Borås, , Sweden
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Gothenburg, , Sweden
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Mölndal, , Sweden
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Partille, , Sweden
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Skene, , Sweden
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Stenungsund, , Sweden
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Uddevalla, , Sweden
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Vänersborg, , Sweden
Countries
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Other Identifiers
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EudraCT No 2004-004374-90
Identifier Type: -
Identifier Source: secondary_id
D6160C00055
Identifier Type: -
Identifier Source: org_study_id
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