Sitagliptin Utilization in Diabetic Patients with Coronary Artery Disease for Improving Cardiovascular Outcomes (SUPERIOR study)

Sitagliptin Utilization in Diabetic Patients with Coronary Artery Disease for Improving Cardiovascular Outcomes (SUPERIOR study) - Sitagliptin Utilization in Diabetic Patients with Coronary Artery Disease for Improving Cardiovascular Outcomes (SUPERIOR study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011894

Enrollment

1200

Registered

2013-09-27

Start date

2011-05-01

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

Coronary artery disease, Type 2 diabetes mellitus

Interventions

DPP4 inhibitor (sitagliptin) treatment group Intensification of conventional treatment group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Type 2 diabetes mellitus patients with acute coronary syndrome and stable condition. 2) Coronary artery disease patients with type 2 diabetes mellitus Patients with coronary artery disease documented by CAG or CT with organic coronary stenosis of >50% in major coronary arteries.

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes mellitus patients 2) Patients with severe diabetic ketosis, or nonketotic hyperosmolar coma within 6 months preceding enrollment 3) Patients needed treatment by DPP-4 inhibitors 4) Patients receiving GLP-1 receptor analogues injection 5) Patients needed treatment by glinide drugs 6) Patients with active systemic inflammatory disease, severe trauma, before and after the operation, and active hepatic disease 7) Unstable patients with Cerebral infarction, Cerebral hemorrhage, Subarachnoid hemorrhage, and transient ischemic attack within 1 month preceding enrollment 8) Patients with heart failure (New York Heart Association functional class III and IV, BNP more than 400pg/mL, or left ventricular ejection fraction <35%) 9) Patients planed coronary and peripheral artery revascularization 10) Patients with peripheral ischemic ulcer and gangrene 11) Patients treated by DPP-4 inhibitors at enrollment 12) Patients with pregnant, lactating, or planned or possible pregnant 13) Patients with a history of hypersensitivity to study drug 14) Ineligible patients for any other reasons

Design outcomes

Primary

Measure	Time frame
Cardiovascular events (composite of cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, non-fatal ischemic stroke, hospitalization fordecompensated heart failure, coronary revascularization, deep vein thrombosis, pulmonary embolism, or hospitalization for peripheral artery disease)	—

Secondary

Measure	Time frame
All cause death Hypoglycemic and hyperglycemic coma Event The change of parameters (GLP-1, BNP, high sensitivity CRP, IL-6 and other biochemical markers, blood pressure, body weight, heart rate, and waist circumference) Coronary angiography finding (Percent atheroma volume, the change of percent atheroma volume) The change of parameters in echocardiography Endothelial function assessed by reactive hyperemia peripheral arterial tonometry	—

Measure

Time frame

All cause death Hypoglycemic and hyperglycemic coma Event The change of parameters (GLP-1, BNP, high sensitivity CRP, IL-6 and other biochemical markers, blood pressure, body weight, heart rate, and waist circumference) Coronary angiography finding (Percent atheroma volume, the change of percent atheroma volume) The change of parameters in echocardiography Endothelial function assessed by reactive hyperemia peripheral arterial tonometry

—

Countries

Japan

Contacts

Public ContactJunichi Matsubara

Kumamoto University, Faculty of Life Sciences Department of Cardiovascular Medicine

j-matsu@kumamoto-u.ac.jp096-373-5175

Outcome results

None listed

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