| Trial ID: | L3593 |
| Source ID: | NCT01398267
|
| Associated Drug: |
Aleglitazar
|
| Title: |
A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: aleglitazar|DRUG: lisinopril|DRUG: placebo
|
| Outcome Measures: |
Primary: Glomerular filtration rate (mGFR), measured as iohexol clearance, 4 weeks | Secondary: 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|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
|
| Sponsor/Collaborators: |
Sponsor: Hoffmann-La Roche
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
55
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose:
|
| Start Date: |
2011-08
|
| Completion Date: |
2012-10
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-02
|
| Locations: |
Chula Vista, California, 91911, United States|Omaha, Nebraska, 68154, United States|Dallas, Texas, 75247, United States|San Antonio, Texas, 78209, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01398267
|
