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SGLT-2i, Heart, Improvement of Cardiovascular Autonomic Neuropathy
EU CTIS ID: 2025-521748-39-00
What this study is testing
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;
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Type 1 diabetes mellitus
- chronic obstructive lung disease with evidence of bronchospasm (e.g. asthma)
- long QT syndrome
- severe hypotension
- 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
See the full eligibility criteria
- 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
- Type 1 diabetes mellitus
- chronic obstructive lung disease with evidence of bronchospasm (e.g. asthma)
- long QT syndrome
- severe hypotension
- 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
- Female during pregnancy and breastfeeding
- Certified or suspected hypersensitivity to SGLT2 inhibitors
- 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;
- diagnosis of chronic obstructive pulmonary disease or respiratory failure
- inability to provide informed consent
- patients with history of breast, bladder and prostate cancer
- 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
- sick sinus syndrome, second or third degree atrio-ventricular block (except in patients with a functioning artificial pacemaker)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.