Efficacy Comparison of Polyethylene Glycol Loxenatide and Gliclazide on the Brain Function in T2DM Patients
NCT06217887 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2024-01-23
Summary
This is a prospective, randomized, open label, parallel,4-month study to explore and evaluate the therapeutic effects of polyethylene glycol loxenatide on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with normal cognitive status or MCI.
Conditions
- Type 2 Diabetes Mellitus
- Cognitive Function Abnormal
Interventions
- DRUG
-
loxenatide Group
Loxenatide will be initiated and maintained at 0.2mg once weekly until the completion of the study. All patients will also continue on their existing dose and regimen of metformin throughout the study.
- DRUG
-
Gliclazide Group
Gliclazide will be initiated and maintained at 30mg/day every morning. If necessary, the dose can be increased to 120mg once daily. All patients will also continue on their existing dose and regimen of metformin throughout the study.
Sponsors & Collaborators
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-10
- Primary Completion
- 2024-02-29
- Completion
- 2024-06-30
Countries
- China
Study Locations
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