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SGLT2 Inhibitors and Cognitive Function in Adults With Type 2 Diabetes (SaveMinD)

NCT07694596 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-07-10

No results posted yet for this study

Summary

This study is a prospective, randomized, open-label trial with blinded outcome assessment (PROBE design) designed to evaluate the effects of sodium-glucose cotransporter-2 (SGLT2) inhibitor therapy on cognitive function in adults with type 2 diabetes mellitus (T2D). A total of 200 participants aged 50 years or older with T2D of at least five years' duration and HbA1c ≤8.5% will be randomized in a 1:1 ratio to receive either standard diabetes care plus an SGLT2 inhibitor or standard diabetes care without an SGLT2 inhibitor. Participants will be followed for 12 months.

The primary objective is to compare changes in executive cognitive function between the two treatment groups using a composite cognitive outcome derived from standardized neuropsychological tests. Secondary objectives include assessment of global cognitive function, glycaemic variability measured by continuous glucose monitoring, metabolic control, circulating biomarkers of neurodegeneration and inflammation, functional status, and treatment safety. Baseline brain magnetic resonance imaging (MRI), APOE genotyping, frailty status, sleep quality, psychological well-being, and physical activity will be evaluated as potential modifiers of cognitive outcomes and treatment response.

The study is intended to provide prospective evidence regarding the association between SGLT2 inhibitor therapy and cognitive outcomes in adults with T2D while exploring the metabolic, neurodegenerative, and behavioural factors that may contribute to cognitive changes over time.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)
  • Cognitive Dysfunction

Interventions

DRUG

SGLT2 Inhibitor

Participants randomized to the intervention group will receive empagliflozin (10 mg once daily, with optional titration to 25 mg according to clinical judgement and tolerability) or dapagliflozin (10 mg once daily) in addition to standard diabetes care. The choice of SGLT2 inhibitor will be made by the treating investigator according to routine clinical practice.

OTHER

Standard Diabetes Care

Individualized diabetes management according to current national and international clinical practice guidelines, including lifestyle counselling and glucose-lowering therapy as clinically indicated. Both study groups will receive standard diabetes care throughout the study.

Sponsors & Collaborators

  • University of Ljubljana, Faculty of Medicine

    collaborator OTHER

  • University of Primorska

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-20
Primary Completion
2028-04-20
Completion
2028-04-20

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07694596 on ClinicalTrials.gov