Conditions: Diabetes Mellitus, Type 2 Acute Coronary Syndrome
Keywords: Diabetes Mellitus - Type 2 Diabetes Mellitus cardiovascular outcomes heart attack stroke dipeptidyl-peptidase IV inhibitors metabolic disorders metabolic diseases glucose metabolism disorders
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 5380
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines. arm 2: Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and \<60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR \<30 mL/min). Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.

Interventions: intervention 1: Alogliptin intervention 2: Placebo
Intervention descriptions: intervention 1: Alogliptin tablets intervention 2: Alogliptin placebo matching tablets

Protocol document: