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This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| aleglitazar | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | oral doses once a day for 26 weeks |
| |
| aleglitazar |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in hemoglobin HbA1c | From baseline to week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lipid profile | From baseline to week 26 | |
| Change from baseline in fasting plasma glucose | From baseline to week 26 | |
| Responder rate as defined of hemoglobin A1c (HbAc1) <7.0% (<6.5%) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chino | California | 91710 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25728612 | Derived | Henry RR, Buse JB, Wu H, Durrwell L, Mingrino R, Jaekel K, El Azzouzi B, Andjelkovic M, Herz M. Efficacy, safety and tolerability of aleglitazar in patients with type 2 diabetes: pooled findings from three randomized phase III trials. Diabetes Obes Metab. 2015 Jun;17(6):560-565. doi: 10.1111/dom.12455. Epub 2015 Apr 8. |
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| Drug |
150 mcg orally once a day for 26 weeks |
|
| From baseline to week 26 |
| Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS) | From baseline to week 26 |
| Change from baseline in homeostatic index of beta cell function (HOMA-BCF) | From baseline to week 26 |
| Safety: incidence of adverse events | 30 weeks (26 weeks treatment and 4 weeks follow-up) |
| Los Angeles |
| California |
| 90057 |
| United States |
| Santa Ana | California | 92701 | United States |
| Thousand Oaks | California | 91360 | United States |
| Upland | California | 91786 | United States |
| West Hills | California | 91307 | United States |
| Boynton Beach | Florida | 33472 | United States |
| Cooper City | Florida | 33024 | United States |
| Coral Gables | Florida | 33134 | United States |
| Jacksonville | Florida | 32216 | United States |
| Kissimmee | Florida | 34741 | United States |
| Atlanta | Georgia | 30338 | United States |
| Chicago | Illinois | 60607 | United States |
| Avon | Indiana | 46123 | United States |
| City of Saint Peters | Missouri | 63376 | United States |
| Greensboro | North Carolina | 27408 | United States |
| Portland | Oregon | 97239 | United States |
| Altoona | Pennsylvania | 16602 | United States |
| Scranton | Pennsylvania | 18510 | United States |
| Tipton | Pennsylvania | 16684 | United States |
| Greer | South Carolina | 29651 | United States |
| Knoxville | Tennessee | 37919 | United States |
| Spokane | Washington | 99202 | United States |
| Aguascaliente | 20230 | Mexico |
| Cuernavaca | 62250 | Mexico |
| Culiacán | 80020 | Mexico |
| Durango | 34000 | Mexico |
| Durango | 34080 | Mexico |
| Guadalajara | 44600 | Mexico |
| Mexico City | 11650 | Mexico |
| Monterrey | 64460 | Mexico |
| Pachuca | 42090 | Mexico |
| Querétaro | 76000 | Mexico |
| Tampico | 89000 | Mexico |
| 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 |
|---|---|
| C542437 | aleglitazar |
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