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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000088-10 | EudraCT Number |
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This randomized, double-blind, placebo-controlled study will evaluate the potential of aleglitazar to reduce the risk of end stage renal disease and cardiovascular mortality in patients with type 2 diabetes mellitus and chronic kidney disease. Patients will be randomized to receive oral daily doses of aleglitazar or matching placebo. The anticipated time on study treatment is approximately 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aleglitazar Arm | Experimental |
| |
| Placebo Arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aleglitazar | Drug | Aleglitazar 150 mcg oral doses, once a day for approximately 3 years |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death | Approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the first occurrence of any component of major adverse cardiovascular event composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) | Approximately 5 years | |
| Time to the first occurrence of any component of macrovascular composite (CV death, non fatal myocardial infarction, hospitalization for unstable angina, non fatal stroke) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007674 | Kidney Diseases |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C542437 | aleglitazar |
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| Placebo |
| Drug |
Matching placebo to aleglitazar, once a day for approximately 3 years |
|
| Approximately 5 years |
| Time to the first occurrence of any component of composite outcome of end-stage renal disease and all-cause mortality | Approximately 5 years |
| D004700 | Endocrine System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |