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

Sponsored by Hoffmann-La Roche, July 2010

Purpose

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. The target sample size is 6000-7000 patients. 

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Aleglitazar Drug: Placebo	Phase III

Eligibility
 

Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers:

18 Years and older Both No

Criteria

Inclusion Criteria:

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

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

Contacts and Locations

Physicians:
Ameer Kabour, MD
Raza Hashmi, MD
Tarif Kanaan, MD
Mohammad Alkhateeb, MD

Coordinators:
Michelle Hickam, RN, BSN
Brenda Hoagland, RN, CCRC
Julie Neidhardt, RN, BSN

Please contact us at 419-251-4919 for further information about this study.