Heart Failure Clinical Trial
A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.
Summary
This 2 arm study will compare the safety, tolerability and efficacy of aleglitazar and Actos in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible patients will be randomized to receive either aleglitazar, titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily, or Actos, titrated to an individual maximum tolerated dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
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:
type 1 diabetes;
current or previous treatment with insulin;
uncontrolled hypertension;
NYHA class 1, 3 or 4 at screening.
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There are 45 Locations for this study
Jonesboro Arkansas, 72401, United States
Carmichael California, 95608, United States
Loma Linda California, 92354, United States
Long Beach California, 90822, United States
Jacksonville Florida, 32216, United States
Slidell Louisiana, 70458, United States
Minneapolis Minnesota, 55455, United States
Cleveland Ohio, 44195, United States
Oklahoma City Oklahoma, 73112, United States
Tulsa Oklahoma, 74104, United States
Ashkelon , 78278, Israel
Haifa , 31096, Israel
Kfar Saba , 44281, Israel
Culiacan , SIN80, Mexico
Guadalajara , JAL44, Mexico
Metepec , EMEX5, Mexico
Mexico City , 11650, Mexico
Mexico City , DF706, Mexico
Monterrey , 64000, Mexico
Pachuca , 42000, Mexico
San Luis Potosi , SLP78, Mexico
Arad , 31003, Romania
Bacau , 60011, Romania
Baia Mare , 43012, Romania
Bucuresti , 01024, Romania
Bucuresti , 20475, Romania
Bucuresti , 50452, Romania
Oradea , 41016, Romania
Ploiesti , 10009, Romania
Targoviste , 13008, Romania
Moscow , 12343, Russian Federation
Moscow , 12510, Russian Federation
Moscow , 12701, Russian Federation
Moscow , 12729, Russian Federation
Saratov , 41002, Russian Federation
St Petersburg , 19102, Russian Federation
St Petersburg , 19820, Russian Federation
St Petersburg , 19910, Russian Federation
Yaroslavl , 15006, Russian Federation
Donetsk , 83003, Ukraine
Donetsk , 83114, Ukraine
Kharkov , 61178, Ukraine
Kiev , 02091, Ukraine
Kiev , 1151, Ukraine
Kiev , 2091, Ukraine
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