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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actos | Active Comparator |
| |
| Aleglitazar | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actos | Drug | Titrated to an individual maximum tolerated dose up to 45mg p.o. daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period. | 26 week |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters. | 26 week | |
| Efficacy: Change from baseline to week 26 in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI) and lipid profile. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonesboro | Arkansas | 72401 | United States | |||
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| aleglitazar |
| Drug |
Titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily |
|
| 26 week |
| 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 |
| Culiacán | SIN80020 | Mexico |
| Guadalajara | JAL44340 | Mexico |
| Metepec | EMEX52140 | Mexico |
| Mexico City | 11650 | Mexico |
| Mexico City | DF7060 | Mexico |
| Monterrey | 64000 | Mexico |
| Pachuca | 42000 | Mexico |
| San Luis Potosí City | SLP78250 | Mexico |
| Arad | 310037 | Romania |
| Bacau | 600114 | Romania |
| Baia Mare | 430123 | Romania |
| Bucharest | 010242 | Romania |
| Bucharest | 20475 | Romania |
| Bucharest | 50452 | Romania |
| Oradea | 410169 | Romania |
| Ploieşti | 100097 | Romania |
| Targoviste | 130083 | Romania |
| Moscow | 123436 | Russia |
| Moscow | 125101 | Russia |
| Moscow | 127018 | Russia |
| Moscow | 127299 | Russia |
| Saint Petersburg | 191025 | Russia |
| Saint Petersburg | 198205 | Russia |
| Saint Petersburg | 199106 | Russia |
| Saratov | 410028 | Russia |
| Yaroslavl | 150062 | Russia |
| Donetsk | 83003 | Ukraine |
| Donetsk | 83114 | Ukraine |
| Kharkiv | 61178 | Ukraine |
| Kiev | 02091 | Ukraine |
| Kiev | 1151 | Ukraine |
| Kiev | 2091 | Ukraine |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| C542437 | aleglitazar |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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