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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221209

Enrollment

5400

Registered

2010-08-17

Start date

2010-08-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2 and Acute Coronary Syndrome

Interventions

investigational material(s) Generic name etc : Alogliptin (SYR-322, SYR110322) INN of investigational material : Alogliptin Therapeutic category code : 396 Antidiabetic agents Dosage and Administratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Diagnosis of type 2 diabetes mellitus 2)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) 3)Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization

Exclusion criteria

Exclusion criteria: 1)Signs of type 1 diabetes mellitus 2)Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening 3)Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
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).	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026