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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT01042769

Run by

Hoffmann-La Roche

People needed

7226

Starts

2010-02-01

Expected to finish

2013-11-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Banning, California, United States
• Study site — Carmichael, California, United States
• Study site — Fresno, California, United States
• Study site — Fullerton, California, United States
• Study site — Glendale, California, United States
• Study site — Hawaiian Gardens, California, United States
• Study site — Inglewood, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Northridge, California, United States
• Study site — Orange, California, United States
• Study site — Pomona, California, United States
• Study site — Redondo Beach, California, United States
• Study site — Salinas, California, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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