None listed
Conditions
Interventions
Eligible patients will be randomized in 2 arms in a 1:1 ratio. Eligible patients will receive 150 μ
g aleglitazar or matching placebo orally, once daily, preferably at the same time of the day throughout the study. All participants will be managed according to the best judgment of their treating phy
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
40 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male and female patients with established evidence of stable CVD defined as at least one of the following groups of criteria (A or B): A. Age ≥ 40 years with history of a prior CV event (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 the 2010 ADA criteria. Treatment may include diet alone, or any approved glucose-lowering therapies except for thiazolidinediones (TZDs) B. No fulfillment of criteria A but evidence of glucose abnormalities. • Ability and willingness to give written informed consent and to comply with the requirements of the study. • Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines.
Exclusion criteria
Exclusion criteria: • Current treatment with a TZD or fibrate • Prior intolerance to a TZD or fibrate • Previous participation in a trial with aleglitazar • Other types of diabetes • Inadequate liver, hematologic or renal function as defined by protocol • Symptomatic congestive heart failure classified as NYHA class II-IV • Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding the randomization • Peripheral edema which in the judgment of the investigator is believed to be clinically 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 cases of basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years • Women with a positive pregnancy test, breast feeding or of childbearing potential not using medically approved, highly effective methods of contraception • Participation in any clinical trial.
Countries
Argentina, Australia, Austria, Belarus, Brazil, Canada, Chile, China, Colombia, Czech Republic, Estonia, Finland, France, Germany, Hungary, India, Indonesia, Israel, Italy, Korea South, Latvia, Lithuania, Malasya, Mexico, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Switzerland, Thailand, Ukraine, United Kindgdom, United States
Contacts
Public ContactRosa Adela Chamorro
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed