Effect of the antidiabetic drug DAPAgliflozin on the coronary macrovascular and MICROvascular function in type 2 diabetic patients (DAPAMICRO)

INTERVENTION: Trade Name: Forxiga Pharmaceutical Form: Tablet INN or Proposed INN: Dapagliflozin CAS Number: 461432‐26‐8 Other descriptive name: propylène glycol monohydraté de dapagliflozine Concentration unit: kBq/mg kilobecquerel(s)/milligram Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Coronary macrovascular and microvascular function of type 2 diabetic patients with stable coronary artery disease and acute coronary syndrome (excluding ST elevation myocardial infarction). Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: To assess the effects of dapagliflozin [sodium‐glucose linked transporter 2 (SGLT2) inhibitor] on:; 1.The coronary flow reserve (CFR); 2.The physiology of coronary macrocirculation (epicardial coronary segments), as measured by fractional flow reserve (FFR); 3.The physiology of the coronary microcirculation, as measured by the index of microvascular resistance (IMR).; in T2DM patients with stable CAD or ACS (excluding STEMI) referred for coronary angiography. For NSTEMI or unstable angina ACS patients, the non‐culprit vessels will be interrogated.; Primary end point(s): The objective is to determine the effects of dapaglifozin and the standard of care on the longitudinal change of CFR, FFR and IMR. ; The longitudinal change (?) is defined as the value at follow‐up (6 months) minus the value at baseline. Comparisons between the study arms, using the standard of care as a comparator will be made, in order to explore the relative effect of drugs on the physiology of the coronary macro and microcirculation.; Secondary Objective: "Not applicable" Timepoint(s) of evaluation of this end point: 6 months after enrolment in the study. SECONDARY OUTCOME: Secondary end point(s): Not applicable Timepoint(s) of evaluation of this end point: NA INCLUSION CRITERIA: 1. T2DM patients presenting with stable angina and a clinical indication for cardiac catheterization 2. T2DM patients with NSTEMI or unstable angina referred for cardiac catheterization 3. Demonstration of coronary lesion(s) with non‐significant fractional flow reserve (FFR) values (>0.80), for which revascularisation is deferred 4. Agreement to practice an acceptable method of birth control for women of childbearing potential 5. Signed patient informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50