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This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar compared with placebo when added to a sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or sulfonylurea plus metformin 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 |
|---|---|---|---|
| aleglitazar | Experimental |
| |
| placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aleglitazar | Drug | 150 mcg orally once a day for 26 weeks |
| |
| 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 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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| placebo |
| Drug |
oral doses 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 markers of insulin sensitivity and cardiovascular risk | 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 |
| San Diego | California | 92161 | United States |
| Santa Ana | California | 92701 | United States |
| Jacksonville | Florida | 32216 | United States |
| Kissimmee | Florida | 34741 | United States |
| St. Petersburg | Florida | 33716 | United States |
| Atlanta | Georgia | 30338 | United States |
| Avon | Indiana | 46123 | United States |
| Bethesda | Maryland | 20817 | United States |
| Durham | North Carolina | 27713 | United States |
| Morrisville | Pennsylvania | 19067 | United States |
| Greer | South Carolina | 29651 | United States |
| Dallas | Texas | 75230 | United States |
| Richmond | Virginia | 23249 | United States |
| Buenos Aires | 1056 | Argentina |
| Caba | C1428DCO | Argentina |
| Rosario | S2000CXP | Argentina |
| Bogotá | Colombia |
| Floridablanca | Colombia |
| Medellin-Antioquia | Colombia |
| Guatemala City | 01010 | Guatemala |
| Guatemala City | 01014 | Guatemala |
| Aguascaliente | 20230 | Mexico |
| Celaya | 38000 | Mexico |
| Guadalajara | 44600 | Mexico |
| Guadalajara | 44650 | Mexico |
| Querétaro | 76000 | 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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