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This 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function. Eligible patients will be randomized to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function and efficacy parameters will be assessed at intervals during the treatment period. 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 |
|---|---|---|---|
| Aleglitazar | Experimental |
| |
| Actos | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actos | Drug | 45mg po daily |
| |
| aleglitazar |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline in glomerular filtration rate | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR) | 26 weeks | |
| Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI). | End of treatment |
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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 |
|---|---|---|---|---|---|---|
| Peoria | Arizona | 85381 | United States | |||
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| Drug |
0.6mg po daily |
|
| Adverse events (AEs), laboratory parameters. | Throughout study |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Fresno | California | 93720 | United States |
| Los Gatos | California | 95032 | United States |
| Mission Viejo | California | 92691 | United States |
| Jacksonville | Florida | 32216-4313 | United States |
| Omaha | Nebraska | 68131 | United States |
| Charlotte | North Carolina | 28211 | United States |
| Marion | Ohio | 43302 | United States |
| Altoona | Pennsylvania | 16602 | United States |
| Arlington | Texas | 76014 | United States |
| Arlington | Texas | 76017 | United States |
| Dallas | Texas | 75231 | United States |
| Midland | Texas | 79707 | United States |
| San Antonio | Texas | 78284 | United States |
| Norfolk | Virginia | 23510 | United States |
| Chihuahua City | 31238 | Mexico |
| Chihuahua City | 31328 | Mexico |
| Hermosillo | 83067 | Mexico |
| Metepec | EMEX52140 | Mexico |
| Mexico City | 11650 | Mexico |
| Mexico City | 14000 | Mexico |
| Mexico City | 14050 | Mexico |
| Monterrey | 64000 | Mexico |
| Zapopan | 45200 | Mexico |
| Manati | 00674 | Puerto Rico |
| Ponce | 00717-322 | Puerto Rico |
| Toa Baja | 00949 | Puerto Rico |
| Moscow | 109472 | Russia |
| Moscow | 125101 | Russia |
| Moscow | 127299 | Russia |
| Moscow | 127486 | Russia |
| Moscow | 129110 | Russia |
| Saint Petersburg | 191025 | Russia |
| Saint Petersburg | 197198 | Russia |
| Saint Petersburg | 198205 | Russia |
| Saint Petersburg | 199106 | Russia |
| Saratov | 410038 | Russia |
| Tyumen | 625023 | Russia |
| Yaroslavl | 150062 | Russia |
| Dnipro | 49005 | Ukraine |
| Dnipro | 49060 | Ukraine |
| Donetsk | 83003 | Ukraine |
| Donetsk | 83114 | Ukraine |
| Kharkiv | 61039 | Ukraine |
| Kharkiv | 61178 | Ukraine |
| Kiev | 02091 | Ukraine |
| Kiev | 2091 | Ukraine |
| Kiev | 2125 | Ukraine |
| Lugnansk | 91045 | Ukraine |
| Poltava | 36024 | Ukraine |
| Ternopil | 46002 | 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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