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

Roche

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: placebo

Drug: lisinopril

Drug: aleglitazar

Study type

Interventional

Funder types

Industry

Identifiers

NCT01398267

BP25328

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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