A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01398267

Enrollment

Registered

2011-07-20

Start date

2011-08-31

Completion date

2012-10-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

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.

Interventions

DRUGaleglitazar

150 mcg orally daily, 4 weeks (Day 15 to Day 43)

DRUGlisinopril

20 mg orally daily, 6 weeks (Day 1 to Day 43)

DRUGplacebo

aleglitazar matching placebo orally daily, 4 weeks (Day 15 to Day 43)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Glomerular filtration rate (mGFR), measured as iohexol clearance	4 weeks

Secondary

Measure	Time frame
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
Estimated glomerular filtration rate, using modification of diet in renal disease formula (eGFR[MDRD])	4 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
Safety: Incidence of adverse events	up to 18 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026