A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.
NCT ID: NCT00461058
Last Updated: 2016-08-05
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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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2007-05-31
2007-12-31
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
Study Groups
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Actos
Actos
Titrated to an individual maximum tolerated dose up to 45mg p.o. daily
Aleglitazar
aleglitazar
Titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily
Interventions
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Actos
Titrated to an individual maximum tolerated dose up to 45mg p.o. daily
aleglitazar
Titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily
Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes for \>=1 month;
* drug naive, or receiving stable doses of \<=2 oral antihyperglycemic medications;
* HbA1c 6.5-10.0% at screening;
* symptomatic, stable NYHA class 2 heart failure at screening.
Exclusion Criteria
* current or previous treatment with insulin;
* uncontrolled hypertension;
* NYHA class 1, 3 or 4 at screening.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Jonesboro, Arkansas, United States
Carmichael, California, United States
Loma Linda, California, United States
Long Beach, California, United States
Jacksonville, Florida, United States
Slidell, Louisiana, United States
Minneapolis, Minnesota, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Ashkelon, , Israel
Haifa, , Israel
Kfar Saba, , Israel
Culiacán, , Mexico
Guadalajara, , Mexico
Metepec, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Pachuca, , Mexico
San Luis Potosí City, , Mexico
Arad, , Romania
Bacau, , Romania
Baia Mare, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Oradea, , Romania
Ploieşti, , Romania
Târgovişte, , Romania
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Yaroslavl, , Russia
Donetsk, , Ukraine
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Countries
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Other Identifiers
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BC20265
Identifier Type: -
Identifier Source: org_study_id
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