NCT07694596 · ACTIVE NOT RECRUITING
SGLT2 Inhibitors and Cognitive Function in Adults With Type 2 Diabetes (SaveMinD)
SaveMinD is testing whether adding an SGLT2 inhibitor — a common diabetes drug like empagliflozin or dapagliflozin — helps preserve or improve cognitive function in people with type 2 diabetes, compared to standard diabetes care alone. Two hundred adults age 50 and older will be followed for 12 months, with thinking and memory tests as the main outcome. This is a Phase NA randomized trial — meaning it is an exploratory study generating evidence, not a proven treatment.
You may qualify if
- adults aged 50 years or older.
- diagnosis of type 2 diabetes mellitus according to current American Diabetes - - association (ADA) diagnostic criteria.
- duration of type 2 diabetes mellitus of at least 5 years.
- glycated haemoglobin (HbA1c) ≤8.5% (≤69 mmol/mol) at screening.
- estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m².
- stable glucose-lowering therapy for at least 3 months before enrolment.
- able to complete neuropsychological assessments and all study procedures.
- willing and able to wear a continuous glucose monitoring (CGM) sensor and a physical activity monitor.
- able to provide written informed consent.
You're excluded if
- previous or current treatment with a sodium-glucose cotransporter-2 (SGLT2) inhibitor.
- Montreal Cognitive Assessment (MoCA) score \<20 at screening.
- diagnosis of dementia or another major neurocognitive disorder.
- history of stroke or transient ischaemic attack within the previous 6 months.
- Parkinson's disease, multiple sclerosis, epilepsy, or another major neurological disorder affecting cognitive function.
- severe psychiatric illness likely to interfere with study participation or cognitive assessment.
- estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m².
- history of diabetic ketoacidosis.
- recurrent urinary tract infections (≥3 episodes during the previous year).
- contraindication to magnetic resonance imaging (MRI).
- pregnancy, breastfeeding, or planned pregnancy during the study period.
- active malignancy requiring systemic treatment (except adequately treated non-melanoma skin cancer).
- moderate or severe hepatic impairment (Child-Pugh Class B or C).
- alcohol or substance abuse likely to interfere with study participation.
- presence of an established indication for mandatory SGLT2 inhibitor therapy according to current international clinical practice guidelines (e.g., symptomatic heart failure or chronic kidney disease).
- participation in another interventional clinical trial within the previous 30 days.
- any medical condition that, in the opinion of the investigator, could compromise participant safety, adherence to the protocol, or interpretation of study results.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-07-10