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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01042769
First received: January 5, 2010
Last updated: October 20, 2014
Last verified: October 2014

January 5, 2010
October 20, 2014
February 2010
November 2013   (final data collection date for primary outcome measure)
Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke [ Time Frame: Throughout study, approximately 4.5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01042769 on ClinicalTrials.gov Archive Site
  • Tolerability and long-term safety profile [ Time Frame: Throughout study, approximately 4.5 years ] [ Designated as safety issue: No ]
  • Effects on other cardiovascular endpoints [ Time Frame: Throughout study, approximately 4.5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Tolerability and long-term safety profile [ Time Frame: Throughout study, approximately 4.5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)

This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitaz ar compared to placebo on top of standard care in patients with recent acute cor onary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized t

o 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 a t least 2.5 years.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Aleglitazar
    aleglitazar 150 micrograms po daily
  • Drug: Placebo
    placebo control po daily
  • Experimental: 1
    Intervention: Drug: Aleglitazar
  • Placebo Comparator: 2
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7226
November 2013
November 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India,   United States,   Argentina,   Australia,   Brazil,   Canada,   China,   Czech Republic,   Denmark,   France,   Germany,   Grenada,   Hungary,   United Kingdom,   Ireland,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Poland,   Romania,   Russian Federation,   Spain,   Sweden,   Thailand
 
NCT01042769
BC22140, 2009-012269-71
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP