Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome (EXAMINE)
Diabetes Mellitus, Type 2, Acute Coronary Syndrome

About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus - Type 2, Diabetes Mellitus, cardiovascular outcomes, heart attack, stroke, dipeptidyl-peptidase IV inhibitors, metabolic disorders, metabolic diseases, glucose metabolism disorders
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of type 2 diabetes mellitus
- 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 participant'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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Placebo
Alogliptin
Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
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.