A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus | Completed
A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus
Health Conditions
  • Diabetes Mellitus, Type 2
Completed
Recruitment Status
NCT01042769
Primary Trial ID Number
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.
Primary Outcome Measures
  • Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke; Throughout study, approximately 4.5 years
Secondary Outcome Measures
  • 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
Research Question
  • 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.
Design Type
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Ethics Approval
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Publications
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Countries of Recruitment
United States; Argentina; Australia; Brazil; Canada; China; Czech Republic; Denmark; France; Germany; Grenada; Hungary; India; Ireland; Italy; Korea, Republic of; Malaysia; Mexico; Netherlands; New Zealand; Poland; Romania; Russian Federation; Spain; Sweden; Thailand; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
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Participant Inclusion 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 <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 (France and
  • Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)
Participant Exclusion 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 <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 (France and
  • Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)
Interventions
Drug; Aleglitazar; aleglitazar 150 micrograms po daily; [1]; Drug; Placebo; placebo control po daily; [2]
Design Details
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Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific 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)
Secondary Trial Identifying Number
2009-012269-71
Website
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Study Funded By
Hoffmann-La Roche
Funder Type
Sorry, this information is not available
Study Sponsored By
Hoffmann-La Roche
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

05 Jan 2010

Last Updated

01 Jul 2015

Date Record Refreshed on UKCTG

31 Jul 2015