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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01042769

Enrollment

7226

Registered

2010-01-06

Start date

2010-02-28

Completion date

2013-11-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

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.

Interventions

DRUGAleglitazar

aleglitazar 150 micrograms po daily

DRUGPlacebo

placebo control po daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 * Anaemia * 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)

Design outcomes

Primary

Measure	Time frame
Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke	Throughout study, approximately 4.5 years

Secondary

Measure	Time frame
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
Tolerability and long-term safety profile	Throughout study, approximately 4.5 years

Countries

Argentina, Australia, Brazil, Canada, China, Czechia, Denmark, France, Germany, Grenada, Hungary, India, Ireland, Italy, Malaysia, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, South Korea, Spain, Sweden, Thailand, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026