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This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the effect of aleglitazar on renal function, the renin-angiotensin system and the pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to lisinopril for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aleglitazar | Drug | 150 mcg orally daily, 4 weeks (Day 15 to Day 43) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular filtration rate (mGFR), measured as iohexol clearance | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated glomerular filtration rate, using modification of diet in renal disease formula (eGFR[MDRD]) | 4 weeks | |
| Effective renal plasma flow rate (ERPF), measured as Para-amino hippuric acid (PAH) clearance (PAH plasma concentrations) | 4 weeks |
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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 |
|---|---|---|---|---|---|---|
| Chula Vista | California | 91911 | United States | |||
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| lisinopril |
| Drug |
20 mg orally daily, 6 weeks (Day 1 to Day 43) |
|
| placebo | Drug | aleglitazar matching placebo orally daily, 4 weeks (Day 15 to Day 43) |
|
| Electrolyte blood/urine concentrations | 4 weeks |
| Renin-angiotensin system: plasma renin/aldosterone levels) | 4 weeks |
| Anti-diuretic hormone (ADH) blood levels | 4 weeks |
| Safety: Incidence of adverse events | up to 18 weeks |
| Effect of multiple doses of aleglitazar on lisinopril steady-state pharmacokinetics (area under the concentration - time curve [AUC]) | 4 weeks |
| Steady-state pharmacokinetics (AUC) of aleglitazar in co-administration with lisinopril | 4 weeks |
| High density lipoprotein-cholesterol (HDL-C) blood levels | 4 weeks |
| Omaha |
| Nebraska |
| 68154 |
| United States |
| Dallas | Texas | 75247 | United States |
| San Antonio | Texas | 78209 | United States |
| 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 |
| D017706 | Lisinopril |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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