Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome

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.

Inclusion Criteria:

- Diagnosis of type 2 diabetes mellitus

- Subject is receiving monotherapy or combination antidiabetic therapy with a
glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening
(between 7.0 and 11.0%, inclusive, if the subject's antidiabetic regimen includes
insulin)

- Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization

Exclusion Criteria:

- Signs of type 1 diabetes mellitus

- Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type
2 diabetes mellitus at Screening

- Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or
within the 3 months prior to Screening