A study of Aleglitazar in Patients with Stable Cardiovascular disease and Glucose Abnormalities

Conditions: - Stable Cardiovascular Disease and- Diabetes Mellitus Type 2 or Pre-diabetes
MedDRA version: 16.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 16.0Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849
MedDRA version: 16.0Level: LLTClassification code 10036481Term: Pre-diabetesSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2012-000671-16-PL

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 19000

Inclusion Criteria

• Adult patients, >/= 40 years of age
• Prior Cardiovascular event, Coronary, Cerebrovascular or Perhipheral Arterial Disease
• Established Diabetes Mellitus Type 2 or Hba1c>/=5.7%

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 12700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6300

Exclusion Criteria

• Concomitant treatment with a thiazolidinedione and/or fibrate
• Triglycerides >500 mg/dL
• Anaemia
• Estimated glomerular filtration rate < 45 mL/min/1.73m2
• Symptomatic congestive heart failure classified as NYHA class II-IV
• Hospitalisation for congestive heart failure in last year

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 the addition of aleglitazar versus placebo will reduce a composite outcome of CV death, non-fatal myocardial infarction or non-fatal stroke in patients with stable CVD and glucose abnormalities.;Secondary Objective: To further explore the potential of aleglitazar to reduce CV morbidity, all-cause mortality and to delay the onset of T2D.;Primary end point(s): Time to first occurrence of any component of the composite cardiovascular event of CV death, non-fatal MI ad non-fatal stroke;Timepoint(s) of evaluation of this end point: Approximately 6 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to first occurrence of any component of the composite all-cause mortality, non-fatal MI ad non-fatal stroke;Timepoint(s) of evaluation of this end point: Approximately 6 years