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

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ClinicalTrials.gov Identifier: NCT01042769
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Aleglitazar Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : February 2010
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Aleglitazar Drug: Aleglitazar
aleglitazar 150 micrograms po daily
Placebo Comparator: Placebo Drug: Placebo
placebo control po daily

Primary Outcome Measures :
  1. Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke [ Time Frame: Throughout study, approximately 4.5 years ]

Secondary Outcome Measures :
  1. Effects on other cardiovascular endpoints [ Time Frame: Throughout study, approximately 4.5 years ]
  2. Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk [ Time Frame: Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter ]
  3. Tolerability and long-term safety profile [ Time Frame: Throughout study, approximately 4.5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042769

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Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche