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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012270-12 |
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This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. In addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. The target sample size is 200-400 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aleglitazar | Experimental |
| |
| pioglitazone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aleglitazar | Drug | Aleglitazar 150 mcg po daily for 52 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function: estimated glomerular filtration rate | Week 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, Tolerability: Adverse events (AEs), laboratory parameters | AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60 | |
| Renal function: estimated glomerular filtration rate | Week 52 |
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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 |
|---|---|---|---|---|---|---|
| Camperdown | New South Wales | 2050 | Australia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25407798 | Derived | Ruilope L, Hanefeld M, Lincoff AM, Viberti G, Meyer-Reigner S, Mudie N, Wieczorek Kirk D, Malmberg K, Herz M. Effects of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on renal function in patients with stage 3 chronic kidney disease and type 2 diabetes: a Phase IIb, randomized study. BMC Nephrol. 2014 Nov 18;15:180. doi: 10.1186/1471-2369-15-180. |
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| pioglitazone |
| Drug |
Pioglitazone 45 mg po daily for 52 weeks |
|
| Effect on blood hemoglobin | Week 52 |
| St Leonards |
| New South Wales |
| 2065 |
| Australia |
| Brisbane | Queensland | 4075 | Australia |
| Elizabeth Vale | South Australia | 5112 | Australia |
| Richmond | South Australia | 3121 | Australia |
| Launceston | Tasmania | 7001 | Australia |
| Melbourne | Victoria | 3004 | Australia |
| Fortaleza | Ceará | 60135-170 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-170 | Brazil |
| São Paulo | São Paulo | 01221-020 | Brazil |
| São Paulo | São Paulo | 04022-001 | Brazil |
| São Paulo | São Paulo | 04231-030 | Brazil |
| Barranquilla | Colombia |
| Bogotá | Colombia |
| Bucaramanga | Colombia |
| Medellin-Antioquia | Colombia |
| San Salvador | El Salvador |
| Aschaffenburg | 63739 | Germany |
| Berlin | 10115 | Germany |
| Damme | 49401 | Germany |
| Dresden | 01307 | Germany |
| Essen | 45359 | Germany |
| Falkensee | 14612 | Germany |
| Mainz | 55116 | Germany |
| Münster | 48145 | Germany |
| Neuwied | 56564 | Germany |
| Reichenbach | 08468 | Germany |
| Rostock | 18059 | Germany |
| Sulzbach-Rosenberg | 92237 | Germany |
| Würzburg | 97072 | Germany |
| Hong Kong | Hong Kong |
| Tuenmen | 852 | Hong Kong |
| Baja | 6500 | Hungary |
| Budapest | 1036 | Hungary |
| Budapest | 1045 | Hungary |
| Budapest | 1135 | Hungary |
| Debrecen | 4032 | Hungary |
| Kecskemét | 6001 | Hungary |
| Miskolc | 3526 | Hungary |
| Sátoraljaújhely | 3980 | Hungary |
| Szeged | 6720 | Hungary |
| Szekszárd | 7100 | Hungary |
| Genoa | Liguria | 16132 | Italy |
| Bergamo | Lombardy | 20128 | Italy |
| Cusano Milanino | Lombardy | 20095 | Italy |
| Milan | Lombardy | 20132 | Italy |
| Pavia | Lombardy | 27100 | Italy |
| Aguascaliente | 20230 | Mexico |
| Chihuahua City | 31238 | Mexico |
| Cuernavaca | 62250 | Mexico |
| Durango | 34080 | Mexico |
| Guadalajara | 44600 | Mexico |
| Guadalajara | 44650 | Mexico |
| Pachuca | 42060 | Mexico |
| Pachuca | 42090 | Mexico |
| Arequipa | Cercado | Peru |
| Lima | 11 | Peru |
| Lima | LIMA 29 | Peru |
| Bucharest | 020475 | Romania |
| Cluj-Napoca | 400006 | Romania |
| Iași | 700 503 | Romania |
| Ploieşti | 100163 | Romania |
| Sibiu | 550245 | Romania |
| Târgu Mureş | 540142 | Romania |
| Chelyabinsk | 454047 | Russia |
| Moscow | 119121 | Russia |
| Moscow | 121069 | Russia |
| Moscow | 125101 | Russia |
| Moscow | 127299 | Russia |
| Moscow | 129110 | Russia |
| Saint Petersburg | 194156 | Russia |
| Saint Petersburg | 195067 | Russia |
| Saint Petersburg | 195257 | Russia |
| Saint Petersburg | 197089 | Russia |
| Saratov | 140018 | Russia |
| Yaroslavl | 150062 | Russia |
| Bratislava | 821 02 | Slovakia |
| Dolný Kubín | 026 01 | Slovakia |
| Levice | 034 01 | Slovakia |
| Lučenec | 984 01 | Slovakia |
| 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 |
| D000077205 | Pioglitazone |
| 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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