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

Phase 1

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: lisinopril; Drug: aleglitazar; Drug: placebo

• Registration Number: NCT01398267
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Study Start: 2011-08
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
2	lisinopril	-
1	aleglitazar	-
1	lisinopril	-

Primary Outcome Measures

Name	Time	Method
Glomerular filtration rate (mGFR), measured as iohexol clearance	4 weeks

Secondary Outcome Measures

Name	Time	Method
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