Type 2 Diabetes MellitusPhase 4NCT07711171
Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive Impairment
A Phase 4 study testing Canagliflozin group, Sitagliptin and Acarbose in people with Type 2 Diabetes Mellitus and Cognitive Impairment, run by Fudan University at 1 site in China.
Trial summary
The prevalence of cognitive dysfunction in diabetic patients is high, which seriously affects the quality of life of patients, and early intervention is of great significance. Central nervous system insulin resistance plays a key role in the pathogenesis of cognitive dysfunction in diabetic patients. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cognitive Impairment
- What is being tested?
- Canagliflozin group, Sitagliptin and Acarbose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2024to 30 Oct 2026
- Phase
- Phase 4
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 40-75 years old;
- HbA1c: 7.0 - 10.0%;
- Moca scale total score between 20-26 (duration of education is more than 10 years) or total score between 20 and 25 (duration of education is less than 10 years);
- sign informed consent;
Who cannot join
- left-handedness;
- duration of diabetes is less than 6 years;
- inability to complete central nervous system magnetic resonance imaging;
- alcohol or drug addiction history;
- use of other oral hypoglycemic drugs within 90 days prior to enrollment except for metformin;
- Family or past history of neurological or psychiatric disorders, pancreatitis, medullary thyroid cancer and multiple endocrine adenomatosis;
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- History of recurrent urinary tract infection and malignant tumor;
- History of severe gastrointestinal diseases and gastroenteric surgery;
- Pregnancy/lactation status;
- Abnormal liver function (liver enzyme index is more than 2.5 times the upper limit of the reference range) or abnormal kidney function (estimated glomerular filtration rate is less than 45ml/min); Type 1 diabetes; other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment and unstable living environment, which are likely to cause loss of follow-up, according to the judgment of the researchers;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cuiping Jiang, master contact
China1 site, 1 recruiting
- Recruiting
Fudan University affiliated Huadong Hospital
Shanghai, Shanghai Municipality
Bin Lu, doctor
About this study
Official title: Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive Impairment- a Prospective, Randomized, Single-blind, Controlled, Single-center, Head-to-head Clinical Cohort Study
The prevalence of cognitive dysfunction in diabetic patients is high, which seriously affects the quality of life of patients, and early intervention is of great significance. Central nervous system insulin resistance plays a key role in the pathogenesis of cognitive dysfunction in diabetic patients. Central insulin resistance observed by functional magnetic resonance imaging (fMRI), may serve as an alternative endpoint for assessing cognitive function. Sodium glucose cotransporter 2 inhibitor (SGLT2i) may improve cognitive impairment by improving central insulin resistance.
Read the detailed description
The prevalence of cognitive dysfunction in diabetic patients is high, which seriously affects the quality of life of patients. Cognitive impairment mainly includes two stages: mild cognitive impairment (MCI) and dementia. Early detection of diabetic patients with MCI and effective intervention measures to prevent and delay the onset of dementia have important clinical value and social significance. With the development of imaging technology, especially fMRI changes in local blood flow and metabolic activities of the brain can be displayed before changes in brain structure. The central insulin resistance status observed by fMRI may serve as an alternative endpoint for assessing cognitive function. SGLT2i has been shown to significantly improve insulin resistance in the central nervous system in previous basic and clinical studies. However, up to now, no head-to-head clinical studies have been reported on SGLT2i and other antidiabetic drugs in patients with MCI.
Based on the above research background, we hypothesize that canagliflozin, as a clinically commonly used SGLT2i, it may improve cognitive function in patients with type 2 diabetes mellitus and MCI by improving insulin resistance in the central nervous system.
- Conditions
- Type 2 Diabetes Mellitus, Cognitive Impairment
- Being tested
- Canagliflozin group, Sitagliptin, Acarbose
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin groupDrug
Canagliflozin,100mg once daily, orally, for 6 months
SitagliptinDrug
Sitagliptin,100mg once daily, orally, for 6 months
AcarboseDrug
Acarbose,100mg three times daily, orally, for 6 months
| Study group | Role | What they receive |
|---|---|---|
| canagliflozin treatment group | Active comparator | Canagliflozin was used once daily, 100 mg/time, orally Receives: Drug: Canagliflozin group |
| sitagliptin treatment group | Placebo comparator | Sitagliptin was used 100mg once daily, orally. Receives: Drug: Sitagliptin |
| Acarbose treatment group | Placebo comparator | Acarbose was used 100mg three times daily, orally. Receives: Drug: Acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes in cerebral blood flow shown by fMRI
the changes in cerebral blood flow shown by fMRI after nasal inhalation of insulin
Measured: 6 months
Secondary outcomes (7)
Montreal Cognitive Assessment Scale (Moca scale)
The Moca scale score ranges from 0 to 30. The higher the score, the better the cognitive function. Scores ranging from 12 to 21 are classified as dementia, while scores between 19 and 26 are classified as MCI. The investigators compare the scores of the Moca scale before and after the intervention.
Measured: 6 months
body composition
The body composition is measured using Beijing Yueqi BIA. The indicators include weight (kg), skeletal muscle (kg), body fat (kg), body mass index (kg/m2), body fat percentage (%), visceral fat area (cm2), waist-to-hip ratio, and skeletal muscle index (kg/m2). The investigators compare the changes in body composition before and after the intervention.
Measured: 6 months
grip strength
The grip strength is evaluated using an electronic grip strength tester. Each hand is tested twice, and the average values are taken. The side with the greater grip strength is selected as the final grip strength. A low grip strength is defined as less than 28 kg for men and less than 18 kg for women. The investigators compare the changes in grip strength before and after the intervention.
Measured: 6 months
glycated hemoglobin
The glycated hemoglobin (%) is measured on an empty stomach, and the investigators compare the changes before and after the intervention.
Measured: 6 months
insulin
The measurement of insulin (mIU/L) is conducted in the fasting state. The investigators compare the changes before and after the intervention.
Measured: 6 months
C-peptide
The measurement of C-peptide (ng/ml) is conducted in the fasting state. The investigators compare the changes before and after the intervention.
Measured: 6 months
blood glucose
The measurement of blood glucose (mmol/L) is conducted in the fasting state. The investigators compare the changes before and after the intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start19 Aug 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Lu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711171
- Sponsor's protocol ID
- 2022XD020
- Status last verified
- Jul 2026
- First submitted
- 2 Feb 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive Impairment- a Prospective, Randomized, Single-blind, Controlled, Single-center, Head-to-head Clinical Cohort Study
- ClinicalTrials.gov ID
- NCT07711171
- Acronym / sponsor ID
- 2022XD020
- Conditions
- Type 2 Diabetes Mellitus, Cognitive Impairment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 17 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.
The prevalence of cognitive dysfunction in diabetic patients is high, which seriously affects the quality of life of patients, and early intervention is of great significance. Central nervous system insulin resistance plays a key role in the pathogenesis of cognitive dysfunction in diabetic patients. Central insulin resistance observed by functional magnetic resonance imaging (fMRI), may serve as an alternative endpoint for assessing cognitive function. Sodium glucose cotransporter 2 inhibitor (SGLT2i) may improve cognitive impairment by improving central insulin resistance.
Detailed description
The prevalence of cognitive dysfunction in diabetic patients is high, which seriously affects the quality of life of patients. Cognitive impairment mainly includes two stages: mild cognitive impairment (MCI) and dementia. Early detection of diabetic patients with MCI and effective intervention measures to prevent and delay the onset of dementia have important clinical value and social significance. With the development of imaging technology, especially fMRI changes in local blood flow and metabolic activities of the brain can be displayed before changes in brain structure. The central insulin resistance status observed by fMRI may serve as an alternative endpoint for assessing cognitive function. SGLT2i has been shown to significantly improve insulin resistance in the central nervous system in previous basic and clinical studies. However, up to now, no head-to-head clinical studies have been reported on SGLT2i and other antidiabetic drugs in patients with MCI.
Based on the above research background, we hypothesize that canagliflozin, as a clinically commonly used SGLT2i, it may improve cognitive function in patients with type 2 diabetes mellitus and MCI by improving insulin resistance in the central nervous system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| canagliflozin treatment group | Active comparator | Drug: Canagliflozin groupCanagliflozin was used once daily, 100 mg/time, orally |
| sitagliptin treatment group | Placebo comparator | Drug: SitagliptinSitagliptin was used 100mg once daily, orally. |
| Acarbose treatment group | Placebo comparator | Drug: AcarboseAcarbose was used 100mg three times daily, orally. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age: 40-75 years old;
- HbA1c: 7.0 - 10.0%;
- Moca scale total score between 20-26 (duration of education is more than 10 years) or total score between 20 and 25 (duration of education is less than 10 years);
- sign informed consent;
Key exclusion criteria (10 listed)
- left-handedness;
- duration of diabetes is less than 6 years;
- inability to complete central nervous system magnetic resonance imaging;
- alcohol or drug addiction history;
- use of other oral hypoglycemic drugs within 90 days prior to enrollment except for metformin;
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 |
|---|---|---|
| Canagliflozin groupCanagliflozin,100mg once daily, orally, for 6 months | Drug | canagliflozin treatment group |
| SitagliptinSitagliptin,100mg once daily, orally, for 6 months | Drug | sitagliptin treatment group |
| AcarboseAcarbose,100mg three times daily, orally, for 6 months | Drug | Acarbose treatment group |
Primary outcome
the changes in cerebral blood flow shown by fMRI
Time frame: 6 months
the changes in cerebral blood flow shown by fMRI after nasal inhalation of insulin
7 secondary outcomes
Montreal Cognitive Assessment Scale (Moca scale)
Time frame: 6 months
body composition
Time frame: 6 months
grip strength
Time frame: 6 months
glycated hemoglobin
Time frame: 6 months
insulin
Time frame: 6 months
C-peptide
Time frame: 6 months
blood glucose
Time frame: 6 months
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 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Cuiping Jiang, master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Canagliflozin group, Sitagliptin and Acarbose in people with Type 2 Diabetes Mellitus and Cognitive Impairment, run by Fudan University at 1 site in China.
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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Bin Lu, doctor (18121186716, lubinfd@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the changes in cerebral blood flow shown by fMRI (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.