A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus

Conditions: Type 2 diabetes patients with a recent acute coronary syndrome (ACS) event
MedDRA version: 14.1Level: PTClassification code 10007649Term: Cardiovascular disorderSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2009-012269-71-CZ

Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 7000

Inclusion Criteria

Adults >18 years of age
Type 2 diabetes mellitus
Hospitalization for ACS event and randomization 2-6 weeks after day of hospitalization

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2300

Exclusion Criteria

Estimated glomerular filtration rate <45mL/min/1.73m2
Concomitant treatment with a thiazolidinedione and/or fibrate
Triglycerides >400 mg/dL
Anaemia
Symptomatic congestive heart failure classified as NYHA class II-IV (France and Germany: Congestive heart failure classified as NYHA class I-IV)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether aleglitazar reduces cardiovascular mortality and morbidity (defined as non-fatal myocardial infarction (MI) and non-fatal stroke) in patients with a recent ACS event and T2D;Secondary Objective: • To evaluate the effects of aleglitazar on other clinical endpoints of cardiovascular risk<br>• To evaluate the effects of aleglitazar on glycemic control, the lipoprotein profile, blood pressure, and biomarkers of cardiovascular risk.<br>• To evaluate the tolerability and long-term safety profile of aleglitazar (with special attention to known PPAR class adverse events such as fluid retention, heart failure, fractures, renal function, musculoskeletal adverse events and liver enzyme elevation).;Primary end point(s): - Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke <br>- Effects on other cardiovascular endpoints ;Timepoint(s) of evaluation of this end point: Throughout study, approximately 4.5 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk <br>2. Tolerability and long-term safety profile ;Timepoint(s) of evaluation of this end point: For 1: Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter <br>For 2: Throughout study, approximately 4.5 years