The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.
Alogliptin is a selective and potent dipeptidyl peptidase-4 inhibitor developed by Takeda for use in patients with type 2 diabetes mellitus. Cardiovascular outcomes is of special interest in the type 2 diabetes mellitus population, particularly in type 2 diabetes mellitus patients who have cardiovascular disease and are at high risk for major adverse cardiac events, such as those patients who have had recent acute coronary syndrome. This study has been designed to evaluate the cardiovascular safety of alogliptin versus placebo in addition to Standard of Care in adults with type 2 diabetes mellitus and acute coronary syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5,380
Alogliptin tablets
Alogliptin placebo matching tablets
Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)
Primary Major Adverse Cardiac Events were defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.
Time frame: From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).
Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)
Secondary MACE composite consisted of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or urgent revascularization due to unstable angina; these events were adjudicated by an independent cardiovascular endpoint committee.
Time frame: From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Dothan, Alabama, United States
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Muscle Shoals, Alabama, United States
Unnamed facility
Cottonwood, Arizona, United States
Unnamed facility
Goodyear, Arizona, United States
Unnamed facility
Mesa, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
...and 898 more locations