A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities

Roche

Status and phase

Completed

Phase 3

Conditions

Cardiovascular Disease, Diabetes Mellitus Type 2

Treatments

Drug: Placebo

Drug: aleglitazar

Study type

Interventional

Funder types

Industry

Identifiers

NCT01715818

2012-000671-16 (EudraCT Number)

BC28027

Details and patient eligibility

About

This randomized, double-blind, placebo-controlled, parallel group, multicenter study will evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive either aleglitazar 150 mcg orally daily or matching placebo.

Enrollment

1,999 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female patients with established evidence of stable cardiovascular disease (CVD) defined as at least one of the following groups of criteria (A or B) A. Age >/= 40 years with history with prior CV event of prior myocardial infarction or prior ischemic stroke (confirmed by brain imaging study), with onset >/= 3 months prior to randomization and stable in the Investigator's judgment B. Age >/= 55 years with evidence of CVD (stable in the Investigator's judgment), defined as at least one of the following: Coronary disease, cerebrovascular disease or peripheral arterial disease as defined by protocol
Patients with glucose abnormalities based on one of the following A-B criteria:

A. Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment may include diet alone, or any glucose-lowering therapies except for thiazolidinediones (TDZs) B. No fulfillment of criterion A) but evidence of glucose abnormalities

Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines

Exclusion criteria

Current treatment with a thiazolidinedione (TDZ) or fibrate
Prior intolerance to a TDZ or fibrate
Previous participation in a trial with aleglitazar
Other types of diabetes
Inadequate liver, hematologic or renal function
Symptomatic heart failure classified as NYHA class II-IV
Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding randomization
Peripheral edema which in the judgment of the Investigator in believed to be severe and of cardiac origin
History of surgical coronary revascularization (CABG) less than 5 years prior to screening, except in cases of subsequent myocardial infarction
Currently scheduled for arterial revascularization procedures
Systemic corticosteroid therapy for > 2 weeks within 3 months prior to screening
Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years