Type 2 Diabetes Mellitus (T2DM)SaveMinDNCT07694596
SGLT2 Inhibitors and Cognitive Function in Adults With Type 2 Diabetes (SaveMinD)
A study testing SGLT2 Inhibitor and Standard Diabetes Care in people with Type 2 Diabetes Mellitus (T2DM) and Cognitive Dysfunction, run by University of Primorska at 1 site in Slovenia.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Cognitive Dysfunction
- What is being tested?
- SGLT2 Inhibitor and Standard Diabetes Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSlovenia
- Study dates
- 20 Jun 2026to 20 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrative Genetic, Molecular and Behavioural Determinants of Cognitive Decline in Type 2 Diabetes: SGLT2 Inhibitors as a Model for Secondary and Tertiary Prevention (SaveMinD)
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.
Read the detailed description
Detailed Description
Type 2 diabetes mellitus (T2D) is associated with an increased risk of cognitive impairment, particularly affecting executive function and processing speed. Multiple mechanisms, including chronic hyperglycaemia, glycaemic variability, vascular dysfunction, systemic inflammation, oxidative stress, and neurodegenerative processes, are thought to contribute to cognitive decline in individuals with T2D.
Sodium-glucose cotransporter-2 (SGLT2) inhibitors have demonstrated cardiovascular and renal benefits and may also exert neuroprotective effects through improvements in metabolic control and modulation of inflammatory and vascular pathways. However, prospective randomized evidence regarding their effects on cognition remains limited.
The SaveMinD study is a prospective, randomized, open-label trial with blinded outcome assessment (PROBE design) evaluating whether the addition of an SGLT2 inhibitor to standard diabetes care influences cognitive outcomes in adults with T2D over 12 months. The primary endpoint is change in executive cognitive function, assessed using a composite score derived from standardized neuropsychological tests. Secondary outcomes include global cognitive function, glycaemic control and variability, circulating biomarkers of neurodegeneration and inflammation, physical activity, functional status, sleep quality, psychological well-being, and safety.
The study also incorporates baseline structural brain magnetic resonance imaging (MRI), APOE genotyping, frailty assessment, continuous glucose monitoring, and objective physical activity monitoring to explore biological and behavioural factors associated with cognitive change. These assessments will be used to investigate potential mechanisms underlying cognitive decline and to identify factors that may modify the response to SGLT2 inhibitor therapy.
The findings are expected to improve understanding of the relationship between metabolic health and cognitive function in T2D and may contribute to the development of strategies for the prevention of diabetes-associated cognitive decline.
- Being tested
- SGLT2 Inhibitor, Standard Diabetes Care
- Keywords
- Type 2 Diabetes Mellitus, SGLT2 inhibitors, cognitive decline, mild cognitive impairment, Executive Function, Glycemic Variability, Neurodegeneration, Diabetes-Related Cognitive Dysfunction
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 InhibitorDrug
Also called empagliflozin or dapagliflozin
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.
Standard Diabetes CareOther
Also called Guideline-Directed 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Diabetes Care + SGLT2 Inhibitor | Experimental | Participants randomized to the intervention group will receive guideline-directed standard diabetes care plus treatment with an SGLT2 inhibitor (empagliflozin or dapagliflozin) according to routine clinical practice. Participants will be followed for 12 months. Receives: Drug: SGLT2 Inhibitor; Other: Standard Diabetes Care |
| Standard Diabetes Care | Active comparator | Participants randomized to the comparator group will receive guideline-directed standard diabetes care without initiation of SGLT2 inhibitor therapy during the study period. Receives: Other: Standard Diabetes Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Executive Cognitive Composite Score
The primary outcome is the between-group difference in change from baseline to Month 12 in the Executive Cognitive Composite Score. The Executive Cognitive Composite Score is a standardized composite measure of executive function and processing speed calculated by averaging z-scores from the Digit Symbol Substitution Test, Trail Making Test Part A and Part B (using the Part B minus Part A completion time), the Digit Span Backward Test, and Verbal Fluency Tests (letter fluency and semantic/category fluency). The composite score is expressed as a standardized z-score and therefore has no fixed theoretical minimum or maximum value. Higher scores indicate better executive cognitive performance.
Measured: Baseline to 12 months
Secondary outcomes (17)
Change in Montreal Cognitive Assessment (MoCA) Score
Change in global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA total score ranges from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Baseline to 12 months
Change in Glycaemic Variability Assessed by Continuous Glucose Monitoring
Percentage coefficient of variation of interstitial glucose measured by continuous glucose monitoring. Range: 0% to 100%; lower values indicate lower glycemic variability (better outcome).
Measured: Baseline, 6 months, and 12 months
Change in HbA1c
Glycated haemoglobin (HbA1c) will be measured in a certified clinical laboratory and reported as percentage (%) according to the National Glycohemoglobin Standardization Program (NGSP). Lower HbA1c values indicate better long-term glycaemic control.
Measured: Baseline, 6 months, and 12 months
Change in High-Sensitivity C-Reactive Protein (hsCRP)
Serum high-sensitivity C-reactive protein (hsCRP) concentration measured in mg/L. Lower concentrations indicate lower systemic inflammation.
Measured: Baseline to 12 months
Change in Neurofilament Light Chain (NfL)
Serum neurofilament light chain (NfL) concentration will be measured in pg/mL. Lower concentrations indicate less neuroaxonal injury.
Measured: Baseline to 12 months
Change in Moderate-to-Vigorous Physical Activity
Moderate-to-vigorous physical activity will be measured using a 14-day accelerometer and expressed as average minutes per day. Higher values indicate greater physical activity.
Measured: Baseline, 6 months, and 12 months
Incidence of Adverse Events and Serious Adverse Events
The number of participants experiencing adverse events (AEs) and serious adverse events (SAEs), including urinary tract infections, genital infections, symptoms suggestive of diabetic ketoacidosis, deterioration in renal function, treatment discontinuation due to adverse events, and other clinically relevant safety events.
Measured: From baseline to 12 months
Change in Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline, 6 months, and 12 months
Change in Anxiety and Depression Symptoms
Symptoms of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). Anxiety and depression subscale scores each range from 0 to 21, with higher scores indicating greater symptom severity.
Measured: Baseline, 6 months, and 12 months
Change in Perceived Stress
Perceived stress will be assessed using the Perceived Stress Scale-10 (PSS-10). Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
Measured: Baseline, 6 months, and 12 months
Change in Interleukin-6 (IL-6)
Serum interleukin-6 (IL-6) concentration measured in pg/mL. Lower concentrations indicate lower systemic inflammation.
Measured: Baseline and Month 12
Change in Tumour Necrosis Factor-Alpha (TNF-α)
Serum tumour necrosis factor-alpha (TNF-α) concentration measured in pg/mL. Lower concentrations indicate lower systemic inflammation.
Measured: Baseline and Month 12
Change from Baseline to Month 12 in Time in Range (3.9-10.0 mmol/L)
Time in Range (TIR) measured using a 14-day continuous glucose monitoring system, defined as the percentage of time during which interstitial glucose concentrations are between 3.9 and 10.0 mmol/L. Values range from 0% to 100%, with higher percentages indicating better glycaemic control.
Measured: Baseline, 6 months, 12 months.
Change from Baseline to Month 12 in Time Below Range (<3.9 mmol/L)
Time Below Range (TBR) measured using a 14-day continuous glucose monitoring system, defined as the percentage of time during which interstitial glucose concentrations are below 3.9 mmol/L. Values range from 0% to 100%, with lower percentages indicating fewer hypoglycaemic events.
Measured: Baseline, 6 months, 12 months
Change in Glial Fibrillary Acidic Protein (GFAP)
Serum glial fibrillary acidic protein (GFAP) concentration will be measured in pg/mL. Lower concentrations indicate lower astroglial activation.
Measured: Baseline to 12 month
Change in Phosphorylated Tau217 (p-tau217)
Serum phosphorylated tau217 (p-tau217) concentration will be measured in pg/mL. Lower concentrations indicate less Alzheimer's disease-related tau pathology.
Measured: Baseline and Month 12
Change in Amyloid-beta42 (Aβ42)
Serum amyloid-beta42 (Aβ42) concentration will be measured in pg/mL. Higher concentrations are generally considered indicative of less Alzheimer's disease-related amyloid pathology.
Measured: Baseline and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start20 Jun 2026
- Primary completion20 Apr 2028 (estimated)
- Study completion20 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either standard diabetes care plus an SGLT2 inhibitor or standard diabetes care without initiation of an SGLT2 inhibitor. Randomization will be centrally performed using a computer-generated allocation sequence and stratified by age and educational attainment to minimize potential confounding related to cognitive performance. Participants will be followed prospectively for 12 months.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine
- Responsible party
- Principal investigator, JanaKomel, University of Primorska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694596
- Sponsor's protocol ID
- 0120-64/2026-2711-6
- Acronym
- SaveMinD
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shin A, Koo BK, Lee JY, Kang EH. Risk of dementia after initiation of sodium-glucose cotransporter-2 inhibitors versus dipeptidyl peptidase-4 inhibitors in adults aged 40-69 years with type 2 diabetes: population based cohort study. BMJ. 2024 Aug 28;386:e079475. doi: 10.1136/bmj-2024-079475.
PubMed 39197881
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Genetic, Molecular and Behavioural Determinants of Cognitive Decline in Type 2 Diabetes: SGLT2 Inhibitors as a Model for Secondary and Tertiary Prevention (SaveMinD)
- ClinicalTrials.gov ID
- NCT07694596
- Acronym / sponsor ID
- SaveMinD / 0120-64/2026-2711-6
- Keywords
- Type 2 Diabetes Mellitus, SGLT2 inhibitors, cognitive decline, mild cognitive impairment, Executive Function, Glycemic Variability, Neurodegeneration, Diabetes-Related Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 20 Apr 2028 (estimated)
- Study completion
- 20 Apr 2028 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Detailed Description
Type 2 diabetes mellitus (T2D) is associated with an increased risk of cognitive impairment, particularly affecting executive function and processing speed. Multiple mechanisms, including chronic hyperglycaemia, glycaemic variability, vascular dysfunction, systemic inflammation, oxidative stress, and neurodegenerative processes, are thought to contribute to cognitive decline in individuals with T2D.
Sodium-glucose cotransporter-2 (SGLT2) inhibitors have demonstrated cardiovascular and renal benefits and may also exert neuroprotective effects through improvements in metabolic control and modulation of inflammatory and vascular pathways. However, prospective randomized evidence regarding their effects on cognition remains limited.
The SaveMinD study is a prospective, randomized, open-label trial with blinded outcome assessment (PROBE design) evaluating whether the addition of an SGLT2 inhibitor to standard diabetes care influences cognitive outcomes in adults with T2D over 12 months. The primary endpoint is change in executive cognitive function, assessed using a composite score derived from standardized neuropsychological tests. Secondary outcomes include global cognitive function, glycaemic control and variability, circulating biomarkers of neurodegeneration and inflammation, physical activity, functional status, sleep quality, psychological well-being, and safety.
The study also incorporates baseline structural brain magnetic resonance imaging (MRI), APOE genotyping, frailty assessment, continuous glucose monitoring, and objective physical activity monitoring to explore biological and behavioural factors associated with cognitive change. These assessments will be used to investigate potential mechanisms underlying cognitive decline and to identify factors that may modify the response to SGLT2 inhibitor therapy.
The findings are expected to improve understanding of the relationship between metabolic health and cognitive function in T2D and may contribute to the development of strategies for the prevention of diabetes-associated cognitive decline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either standard diabetes care plus an SGLT2 inhibitor or standard diabetes care without initiation of an SGLT2 inhibitor. Randomization will be centrally performed using a computer-generated allocation sequence and stratified by age and educational attainment to minimize potential confounding related to cognitive performance. Participants will be followed prospectively for 12 months.
| Arm | Type | Receives |
|---|---|---|
| Standard Diabetes Care + SGLT2 Inhibitor | Experimental | Drug: SGLT2 Inhibitor, Other: Standard Diabetes CareParticipants randomized to the intervention group will receive guideline-directed standard diabetes care plus treatment with an SGLT2 inhibitor (empagliflozin or dapagliflozin) according to routine clinical practice. Participants will be followed for 12 months. |
| Standard Diabetes Care | Active comparator | Other: Standard Diabetes CareParticipants randomized to the comparator group will receive guideline-directed standard diabetes care without initiation of SGLT2 inhibitor therapy during the study period. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 InhibitorAlso: empagliflozin or dapagliflozinParticipants 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. | Drug | Standard Diabetes Care + SGLT2 Inhibitor |
| Standard Diabetes CareAlso: Guideline-Directed Standard Diabetes CareIndividualized 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. | Other | Standard Diabetes Care, Standard Diabetes Care + SGLT2 Inhibitor |
Primary outcome
Change in Executive Cognitive Composite Score
Time frame: Baseline to 12 months
The primary outcome is the between-group difference in change from baseline to Month 12 in the Executive Cognitive Composite Score. The Executive Cognitive Composite Score is a standardized composite measure of executive function and processing speed calculated by averaging z-scores from the Digit Symbol Substitution Test, Trail Making Test Part A and Part B (using the Part B minus Part A completion time), the Digit Span Backward Test, and Verbal Fluency Tests (letter fluency and semantic/category fluency). The composite score is expressed as a standardized z-score and therefore has no fixed theoretical minimum or maximum value. Higher scores indicate better executive cognitive performance.
17 secondary outcomes
Change in Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline to 12 months
Change in Glycaemic Variability Assessed by Continuous Glucose Monitoring
Time frame: Baseline, 6 months, and 12 months
Change in HbA1c
Time frame: Baseline, 6 months, and 12 months
Change in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline to 12 months
Change in Neurofilament Light Chain (NfL)
Time frame: Baseline to 12 months
Change in Moderate-to-Vigorous Physical Activity
Time frame: Baseline, 6 months, and 12 months
Incidence of Adverse Events and Serious Adverse Events
Time frame: From baseline to 12 months
Change in Sleep Quality
Time frame: Baseline, 6 months, and 12 months
Change in Anxiety and Depression Symptoms
Time frame: Baseline, 6 months, and 12 months
Change in Perceived Stress
Time frame: Baseline, 6 months, and 12 months
Change in Interleukin-6 (IL-6)
Time frame: Baseline and Month 12
Change in Tumour Necrosis Factor-Alpha (TNF-α)
Time frame: Baseline and Month 12
Change from Baseline to Month 12 in Time in Range (3.9-10.0 mmol/L)
Time frame: Baseline, 6 months, 12 months.
Change from Baseline to Month 12 in Time Below Range (<3.9 mmol/L)
Time frame: Baseline, 6 months, 12 months
Change in Glial Fibrillary Acidic Protein (GFAP)
Time frame: Baseline to 12 month
Change in Phosphorylated Tau217 (p-tau217)
Time frame: Baseline and Month 12
Change in Amyloid-beta42 (Aβ42)
Time frame: Baseline and month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 39197881Shin A, Koo BK, Lee JY, Kang EH. Risk of dementia after initiation of sodium-glucose cotransporter-2 inhibitors versus dipeptidyl peptidase-4 inhibitors in adults aged 40-69 years with type 2 diabetes: population based cohort study. BMJ. 2024 Aug 28;386:e079475. doi: 10.1136/bmj-2024-079475.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SGLT2 Inhibitor and Standard Diabetes Care in people with Type 2 Diabetes Mellitus (T2DM) and Cognitive Dysfunction, run by University of Primorska at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Executive Cognitive Composite Score (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07694596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.