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

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.

Condition	Intervention	Phase
Diabetes Mellitus Type 2	Drug: Aleglitazar Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]
Tolerability and long-term safety profile [ Time Frame: Throughout study, approximately 4.5 years ] [ Designated as safety issue: No ]


Enrollment:	7226
Study Start Date:	February 2010
Study Completion Date:	November 2013
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Aleglitazar	Drug: Aleglitazar aleglitazar 150 micrograms po daily
Placebo Comparator: Placebo	Drug: Placebo placebo control po daily

Eligibility


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

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 <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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042769

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Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lincoff AM, Tardif JC, Schwartz GG, Nicholls SJ, Rydén L, Neal B, Malmberg K, Wedel H, Buse JB, Henry RR, Weichert A, Cannata R, Svensson A, Volz D, Grobbee DE; AleCardio Investigators. Effect of aleglitazar on cardiovascular outcomes after acute coronary syndrome in patients with type 2 diabetes mellitus: the AleCardio randomized clinical trial. JAMA. 2014 Apr 16;311(15):1515-25. doi: 10.1001/jama.2014.3321.

Lincoff AM, Tardif JC, Neal B, Nicholls SJ, Rydén L, Schwartz GG, Malmberg K, Buse JB, Henry RR, Wedel H, Weichert A, Cannata R, Grobbee DE. Evaluation of the dual peroxisome proliferator-activated receptor α/γ agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial. Am Heart J. 2013 Sep;166(3):429-34. doi: 10.1016/j.ahj.2013.05.013. Epub 2013 Jul 26.


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01042769 History of Changes
Other Study ID Numbers:	BC22140 2009-012269-71
Study First Received:	January 5, 2010
Last Updated:	September 1, 2016
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Acute Coronary Syndrome Glucose Metabolism Disorders Metabolic Diseases	Endocrine System Diseases Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases

ClinicalTrials.gov processed this record on September 27, 2016