A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)

Hoffmann-La Roche0 sites7,226 target enrollmentFebruary 2010

ConditionsDiabetes Mellitus Type 2

InterventionsAleglitazar Placebo

DrugsAleglitazar Placebo

Overview

Phase: Phase 3
Intervention: Aleglitazar
Conditions: Diabetes Mellitus Type 2
Sponsor: Hoffmann-La Roche
Enrollment: 7226
Primary Endpoint: Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

November 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adults \>18 years of age
•Type 2 diabetes mellitus
•Hospitalization for ACS event and randomization between hospital discharge and 8 weeks after the ACS index event (day of hospitalization)

Exclusion Criteria

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

Arms & Interventions

Aleglitazar

Intervention: Aleglitazar

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke

Time Frame: Throughout study, approximately 4.5 years

Secondary Outcomes

Tolerability and long-term safety profile(Throughout study, approximately 4.5 years)
Effects on other cardiovascular endpoints(Throughout study, approximately 4.5 years)
Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk(Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter)