drugset / Trial / NCT06085703
Effects of Henagliflozin on the Brain Function in T2DM Patients With Mild Cognitive Impairment: a Randomized, Parallel Controlled Clinical Trial
Completed
24 enrolled
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a prospective, randomized, open label, parallel, 16-week study to explore and evaluate the therapeutic effects of Henagliflozin on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with mild cognitive impairment (MCI).
Timeline
- Start
- 2024-04-01
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
Publications
- Background Zhang Z, Zhang B, Wang X, Zhang X, Yang QX, Qing Z, Zhang W, Zhu D, Bi Y. Olfactory Dysfunction Mediates Adiposity in Cognitive Impairment of Type 2 Diabetes: Insights From Clinical and Functional Neuroimaging Studies. Diabetes Care. 2019 Jul;42(7):1274-1283. doi: 10.2337/dc18-2584. Epub 2019 May 21.
- Background Zhang Z, Zhang B, Wang X, Zhang X, Yang QX, Qing Z, Lu J, Bi Y, Zhu D. Altered Odor-Induced Brain Activity as an Early Manifestation of Cognitive Decline in Patients With Type 2 Diabetes. Diabetes. 2018 May;67(5):994-1006. doi: 10.2337/db17-1274. Epub 2018 Mar 2.
- Background Cheng H, Zhang Z, Zhang B, Zhang W, Wang J, Ni W, Miao Y, Liu J, Bi Y. Enhancement of Impaired Olfactory Neural Activation and Cognitive Capacity by Liraglutide, but Not Dapagliflozin or Acarbose, in Patients With Type 2 Diabetes: A 16-Week Randomized Parallel Comparative Study. Diabetes Care. 2022 May 1;45(5):1201-1210. doi: 10.2337/dc21-2064.
- Chao Y, Jiao J, Zhang B, Sun J, Tong X, Yang H, Wu T, Zhang Z, Bi Y. Henagliflozin enhances frontal neural activation and cognitive function versus gliclazide in type 2 diabetes patients with mild cognitive impairment: A 16-week randomized controlled trial. J Endocrinol Invest. 2026 Apr;49(4):947-957. doi: 10.1007/s40618-025-02775-2. Epub 2026 Jan 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gliclazide | Small molecule | 30 mg | — |
| Subject | Gliclazide | Small molecule | 120 mg | — |
| Subject | Henagliflozin | Small molecule | 5 mg | — |
| Subject | Henagliflozin | Small molecule | 10 mg | — |