Efficacy and Safety of Canagliflozin in the Treatment of Type 2 Diabetes With Mild Cognitive Impairment

NCT07711171 | Recruiting Phase 4

• 1 other identifier: 2022XD020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 2 Diabetes Mellitus; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• the changes in cerebral blood flow shown by fMRI

  the changes in cerebral blood flow shown by fMRI after nasal inhalation of insulin

  6 months

Secondary Outcomes (7)

• Montreal Cognitive Assessment Scale (Moca scale)

  6 months

• body composition

  6 months

• grip strength

  6 months

• glycated hemoglobin

  6 months

• insulin

  6 months

Study Arms (3)

canagliflozin treatment group

ACTIVE COMPARATOR

Canagliflozin was used once daily, 100 mg/time, orally

Drug: Canagliflozin group

sitagliptin treatment group

PLACEBO COMPARATOR

Sitagliptin was used 100mg once daily, orally.

Drug: Sitagliptin

Acarbose treatment group

PLACEBO COMPARATOR

Acarbose was used 100mg three times daily, orally.

Drug: Acarbose

Interventions

Sitagliptin DRUG

Sitagliptin,100mg once daily, orally, for 6 months

sitagliptin treatment group

Canagliflozin group DRUG

Canagliflozin,100mg once daily, orally, for 6 months

canagliflozin treatment group

Acarbose DRUG

Acarbose,100mg three times daily, orally, for 6 months

Acarbose treatment group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University affiliated Huadong Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cognitive Dysfunction

Interventions

Sitagliptin Phosphate; Acarbose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Central Study Contacts

Bin Lu, doctor

CONTACT

18121186716; lubinfd@126.com

Cuiping Jiang, master

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: July 17, 2026
• Study Start: August 19, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

CN (1)