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

Hoffmann-La Roche0 sites55 target enrollmentAugust 2011

ConditionsDiabetes Mellitus Type 2

Interventionsaleglitazar lisinopril placebo

Drugsaleglitazar lisinopril placebo

Overview

Phase: Phase 1
Intervention: aleglitazar
Conditions: Diabetes Mellitus Type 2
Sponsor: Hoffmann-La Roche
Enrollment: 55
Primary Endpoint: Glomerular filtration rate (mGFR), measured as iohexol clearance
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

October 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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

Arms & Interventions

1

Intervention: aleglitazar

1

Intervention: lisinopril

2

Intervention: lisinopril

2

Intervention: placebo

Outcomes

Primary Outcomes

Glomerular filtration rate (mGFR), measured as iohexol clearance

Time Frame: 4 weeks

Secondary Outcomes

Estimated glomerular filtration rate, using modification of diet in renal disease formula (eGFR[MDRD])(4 weeks)
High density lipoprotein-cholesterol (HDL-C) blood levels(4 weeks)
Effective renal plasma flow rate (ERPF), measured as Para-amino hippuric acid (PAH) clearance (PAH plasma concentrations)(4 weeks)
Renin-angiotensin system: plasma renin/aldosterone levels)(4 weeks)
Electrolyte blood/urine concentrations(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)