Effects of SGLT2 Inhibition on Myocardial Insulin Sensitivity
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
A Phase III, single-centre, randomized, 2-arm, parallel-group, double blind,
placebo-controlled study, consisting of a screening phase (Days -14 to -1), a 4-week
double-blind, placebo-controlled treatment phase and a 4-week follow-up phase.
Subjects: Type 2 diabetic patients and coronary artery diseases (CAD) not requiring
revascularization or underwent percutaneous coronary intervention (PCI) but clinically stable
at time of screening visit, with suboptimal glycaemic control (HbA1c 7.0-8.5%) on their
current anti-hyperglycaemic regimen
Subjects will be randomized in a 1:1 ratio to dapagliflozin or placebo.
Subjects will undergo screening assessment in the 14-day period preceding administration of
the first dose of study drug on Day 1.
The primary Objective is to assess the effect of dapagliflozin on myocardial insulin
sensitivity The Secondary Objective is to assess global heart function, and metabolic
systemic effects of dapagliflozin, and glycemic control.
The study aims to enroll patients with type 2 diabetes with suboptimal glycemic control, and
with coronary artery diseases (CAD) not requiring revascularization or underwent percutaneous
coronary intervention (PCI) but clinically stable, who have already undergone, under routine
cardiological assessment, a positron emission tomography (PET) 13NH3 scan in order to assess
the cardiovascular function. Thus, the study aims to assess whether the improvement in
cardiac metabolism obtained with dapagliflozin is greater than that obtained with normal
clinical practice (according to Standards of Care).