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This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. 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 1 | Experimental |
| |
| Aleglitazar 2 | Experimental |
| |
| Aleglitazar 3 | Experimental |
| |
| Aleglitazar 4 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actos | Drug | 45mg po daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in Hemoglobin A1c (HbA1c) | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers. | 16 weeks | |
| Adverse Events (AEs), laboratory parameters. | Throughout study |
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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 |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85006 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19515415 | Derived | Henry RR, Lincoff AM, Mudaliar S, Rabbia M, Chognot C, Herz M. Effect of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on risk of cardiovascular disease in patients with type 2 diabetes (SYNCHRONY): a phase II, randomised, dose-ranging study. Lancet. 2009 Jul 11;374(9684):126-35. doi: 10.1016/S0140-6736(09)60870-9. Epub 2009 Jun 8. |
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| Drug |
po daily |
|
| aleglitazar | Drug | Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg. |
|
| Phoenix |
| Arizona |
| 85029 |
| United States |
| Beverly Hills | California | 90211 | United States |
| Palm Springs | California | 92262 | United States |
| San Diego | California | 92161 | United States |
| Chiefland | Florida | 32626 | United States |
| Hollywood | Florida | 33023 | United States |
| West Palm Beach | Florida | 33401 | United States |
| Augusta | Georgia | 30909 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Chicago | Illinois | 60611 | United States |
| Baton Rouge | Louisiana | 70809 | United States |
| Baltimore | Maryland | 21229 | United States |
| Olive Branch | Mississippi | 38654 | United States |
| Hamilton | New Jersey | 08610 | United States |
| New Hyde Park | New York | 11042 | United States |
| Johnson City | Tennessee | 37604 | United States |
| Spokane | Washington | 99216 | United States |
| Athens | 12462 | Greece |
| Thessaloniki | 56429 | Greece |
| Hong Kong | Hong Kong |
| Bologna | 40138 | Italy |
| Genova | 16132 | Italy |
| Naples | 80100 | Italy |
| Olbia | 07026 | Italy |
| Pavia | 27100 | Italy |
| Perugia | 06126 | Italy |
| Roma | 00133 | Italy |
| Siena | 53100 | Italy |
| Torino | 10126 | Italy |
| Aguascalientes | 20230 | Mexico |
| Chihuahua City | 31238 | Mexico |
| Cuernavaca | 62250 | Mexico |
| Durango | 34080 | Mexico |
| Guadalajara | 44340 | Mexico |
| Guadalajara | 44650 | Mexico |
| Mexico City | 10700 | Mexico |
| Monterrey | 66260 | Mexico |
| Pachuca | 42086 | Mexico |
| Bucharest | 020475 | Romania |
| Bucharest | Romania |
| Cluj-Napoca | 400006 | Romania |
| Galati | 800352 | Romania |
| Ploieşti | 100163 | Romania |
| Moscow | 117036 | Russia |
| Moscow | 125315 | Russia |
| Moscow | 129090 | Russia |
| Moscow | 129110 | Russia |
| Moscow | 129327 | Russia |
| Saint Petersburg | 197089 | Russia |
| Saint Petersburg | 197198 | Russia |
| Saratov | 410038 | Russia |
| Belgrade | 11000 | Serbia |
| Kragujevac | 34000 | Serbia |
| Niš | 18000 | Serbia |
| 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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