Clinical trial NCT01398267: A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effects of Aleglitazar 150 µg in Type 2 Diabetic Patients Treated With Lisinopril 20 mg on Renal Function, the Renin-angiotensin System and the Pharmacokinetics of Lisinopril
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adult male and female patients, 18 to 65 years of age, inclusive
* Diabetes mellitus Type 2, diagnosed at least 3 months before screening
* Treated with stable dose of metformin for at least 4 weeks prior to screening
* Treated with stable dose of Angiotensin-converting enzyme inhibitor (ACEI) for at least 4 weeks prior to screening
* Body mass index (BMI) 18 to 38 kg/m2, inclusive

Exclusion Criteria:

* Positive for HIV-1, HIV-2, hepatitis B or hepatitis C infection
* Pregnant or lactating females
* Type 1 diabetes or secondary from of diabetes
* History or evidence of proliferative diabetic retinopathy or clinically significant neuropathy
* Clinically significant hepatic disease
* Clinically significant renal impairment
* History or evidence of clinically significant cardio-vascular disease or disorder
* Acute infection or current malignancy requiring treatment except for excised basal cell carcinoma

Primary outcomes:
measure: Glomerular filtration rate (mGFR), measured as iohexol clearance
timeFrame: 4 weeks
Secondary outcomes:
measure: Estimated glomerular filtration rate, using modification of diet in renal disease formula (eGFR[MDRD])
timeFrame: 4 weeks
measure: Effective renal plasma flow rate (ERPF), measured as Para-amino hippuric acid (PAH) clearance (PAH plasma concentrations)
timeFrame: 4 weeks
measure: Electrolyte blood/urine concentrations
timeFrame: 4 weeks
measure: Renin-angiotensin system: plasma renin/aldosterone levels)
timeFrame: 4 weeks
measure: Anti-diuretic hormone (ADH) blood levels
timeFrame: 4 weeks
measure: Safety: Incidence of adverse events
timeFrame: up to 18 weeks
measure: Effect of multiple doses of aleglitazar on lisinopril steady-state pharmacokinetics (area under the concentration - time curve [AUC])
timeFrame: 4 weeks
measure: Steady-state pharmacokinetics (AUC) of aleglitazar in co-administration with lisinopril
timeFrame: 4 weeks
measure: High density lipoprotein-cholesterol (HDL-C) blood levels
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chula Vista
country: United States
state: California
city: Omaha
country: United States
state: Nebraska
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: