SGLT-2 Inhibitor and Myocardial Perfusion, Function and Metabolism in T2 DM Patients at High Cardiovascular Risk

Inclusion Criteria

• •A diagnosis of type 2 diabetes mellitus at least 3 months prior to baseline visit
• •For patients on background therapy: stable dose of anti-diabetics within 30 days prior to baseline
• •HbA1c of ≥6.5% and ≤10% at screening for patients on background therapy or HbA1c of ≥6.5 % and ≤ 9.0% at screening for drug-naïve patients.
• •BMI ≤ 45 kg/m2 at screening
• •Age ≥18 years
• •Negative pregnancy test (fertile women). Fertile women must use safe contraceptives (spiral, hormonal contraceptives) for the duration of the study
• •Able to understand the written patient information and to give informed consent
• •Patients must have high cardiovascular risk, defined as at least one of the following:
• •Albuminuria ( albumin/creatinine ratio ≥ 30 mg/g or plasma NT-proBNP ≥ 70 pg/ml)
• •Confirmed history of myocardial infarction (\>2 months prior to baseline)
• •Heart failure according to the Framingham Heart Failure Criteria
• •Or patient discharged from hospital with a documented diagnosis of unstable angina within 12 months prior to baseline
• •Evidence of coronary artery disease by CAG in 1 or more major coronary arteries
• •OR at least one of the following: a positive noninvasive stress test, or A positive stress echocardiography showing regional systolic wall motion abnormalities, or A positive scintigraphic test showing stress-induced ischemia,
• •History of ischemic or haemorrhagic stroke (\>2 months prior to informed consent)
• •Presence of peripheral artery disease (symptomatic or not ) documented by either: previous limb angioplasty, stenting or bypass surgery; or previous limb or foot amputation due to circulatory insufficiency; or angiographic evidence of significant (\> 50%) peripheral artery stenosis in at least one limb; or evidence from a non-invasive measurement of significant (\>50% or as reported as hemodynamically significant) peripheral artery stenosis in at least one limb; or ankle brachial index of \< 0.9