SGLT-2i, Heart, Improvement of Cardiovascular Autonomic Neuropathy

Trial details

Who runs it

Universita Cattolica Del Sacro Cuore

Trial code

EU 2025-521748-39-00

Record updated

2025. december 9.

Original description

Primary Objective #1: to evaluate whether the cardiovascular effects of SGLT-2is are, at least in part, mediated by autonomic innervation in patients with type 2 diabetes mellitus; Primary Objective #2: to explore the effects of SGLT2is on the progression of CAN in patients affected by type 2 diabetes mellitus;Read full original descriptionShow less

Primary Objective #1: to evaluate whether the cardiovascular effects of SGLT-2is are, at least in part, mediated by autonomic innervation in patients with type 2 diabetes mellitus; Primary Objective #2: to explore the effects of SGLT2is on the progression of CAN in patients affected by type 2 diabetes mellitus;

Inclusion: Informed consent obtained before any study-specific procedures. Patients must be able to understand and be willing to sign a written informed consent; Patients who are intolerant to metformin, or in metformin failure, or present clinical indications for initiating SGLT2 inhibitor therapy (e.g., heart failure, diabetic kidney disease), in accordance with current clinical guidelines; Men and women with type 2 diabetes mellitus; age > 45 years old; patients with stable medical therapy including other anti-hyperglycemic agents alone or in combination with a basal insulin analogue for at least 3 months prior to the screening visit (including stable insulin dose defined as no variation over 30% in daily insulin dose in the preceding 3 months, as evaluated by the Investigator); HbA1c above or equal to 7.0% but less than 8.5% at screening; Women of childbearing potential must have a negative blood or urine pregnancy test at the baseline visit; Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 5.9 of the protocol; Ability to take oral medications; Will and ability to comply with the protocol.

Exclusion: previous diagnosis of Latent Autoimmune Diabetes of Adults (LADA); use of SGLT-2is in the 90 days prior to screening, acute decompensation of glycemic control requiring immediate intensification of treatment to prevent acute complications (e.g. diabetic ketoacidosis) in 90 days prior to screening; acute coronary or cerebro-vascular event in the 90 days prior to randomization, currently planned coronary, carotid or peripheral artery revascularization, NYHA class III or IV, unstable angina; Type 1 diabetes mellitus; chronic obstructive lung disease with evidence of bronchospasm (e.g. asthma); decompensated heart failure; History of diabetic ketoacidosis (DKA), unless a clear and modifiable precipitating factor (e.g., ketogenic diet, excessive alcohol consumption) has been identified and eliminated; Certified or suspected hypersensitivity to SGLT2 inhibitors; diagnosis of chronic obstructive pulmonary disease or respiratory failure; patients with history of breast, bladder and prostate cancer; sick sinus syndrome, second or third degree atrio-ventricular block (except in patients with a functioning artificial pacemaker); long QT syndrome; Patients on dialysis or with estimated glomerular filtration rate (eGFR) below the following thresholds, depending on the assigned treatment: - eGFR <45 mL/min/1.73 m² for patients planned to receive ertugliflozin - eGFR <30 mL/min/1.73 m² for patients planned to receive empagliflozin, canagliflozin, or dapagliflozin; severe hypotension; Female during pregnancy and breastfeeding; inability to provide informed consent.

EU CTIS 2025-521748-39-00