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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
55
150 mcg orally daily, 4 weeks (Day 15 to Day 43)
20 mg orally daily, 6 weeks (Day 1 to Day 43)
aleglitazar matching placebo orally daily, 4 weeks (Day 15 to Day 43)
Unnamed facility
Chula Vista, California, United States
Unnamed facility
Omaha, Nebraska, United States
Unnamed facility
Dallas, Texas, United States
Unnamed facility
San Antonio, Texas, United States
Glomerular filtration rate (mGFR), measured as iohexol clearance
Time frame: 4 weeks
Estimated glomerular filtration rate, using modification of diet in renal disease formula (eGFR[MDRD])
Time frame: 4 weeks
Effective renal plasma flow rate (ERPF), measured as Para-amino hippuric acid (PAH) clearance (PAH plasma concentrations)
Time frame: 4 weeks
Electrolyte blood/urine concentrations
Time frame: 4 weeks
Renin-angiotensin system: plasma renin/aldosterone levels)
Time frame: 4 weeks
Anti-diuretic hormone (ADH) blood levels
Time frame: 4 weeks
Safety: Incidence of adverse events
Time frame: up to 18 weeks
Effect of multiple doses of aleglitazar on lisinopril steady-state pharmacokinetics (area under the concentration - time curve [AUC])
Time frame: 4 weeks
Steady-state pharmacokinetics (AUC) of aleglitazar in co-administration with lisinopril
Time frame: 4 weeks
High density lipoprotein-cholesterol (HDL-C) blood levels
Time frame: 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.