• Time from randomization to the occurrence of the Primary Major Adverse Cardiac Events, defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke. [ Time Frame: At first occurrence (up to 4.75 years). ] [ Designated as safety issue: No ]
  

• Time from randomization to the occurrence of the Secondary Major Adverse Cardiac Events defined as a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke and urgent revascularization due to unstable angina. [ Time Frame: At first occurrence (up to 4.75 years). ] [ Designated as safety issue: No ]
  

Alogliptin is a selective and potent dipeptidyl peptidase-4 inhibitor currently being developed by Takeda for use in patients with type 2 diabetes mellitus. Results from five phase 3 double-blind, placebo-controlled, 26-week studies have demonstrated that alogliptin is effective in reducing glycosylated hemoglobin as monotherapy and when added to commonly used antidiabetic agents, including sulfonylureas, metformin, thiazolidinediones, and insulin. Alogliptin is well-tolerated and associated with few adverse events.

Cardiovascular outcomes is of special interest in the type 2 diabetes mellitus population, particularly in type 2 diabetes mellitus subjects 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 subjects with type 2 diabetes mellitus and acute coronary syndrome.