Status:
RECRUITING
Efficacy Comparison of Polyethylene Glycol Loxenatide and Gliclazide on the Brain Function in T2DM Patients
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Type 2 Diabetes Mellitus
Cognitive Function Abnormal
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief 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, a...
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- patients with type 2 diabetes mellitus ;
- Aged:40 -75 years ;
- Cognitive function assessment suggests normal status or mild cognitive impairment;
- a stable dose of metformin monotherapy (≥1,500 mg daily) for at least 90 days,
- HbA1c 7 - 10%;
- ≥6 years of education;
- Right-handed.
Exclusion
- patients unable to complete brain MRI scanning;
- nasal disease that affected olfactory function;
- hepatic dysfunction with liver transaminases \> 2.5 times upper normal limits and renal impairment with an estimated glomerular filtration rate \< 60ml/min/1.73m2 ;
- acute cardio/cerebrovascular disease, psychiatric disorders, pancreatitis, acute infection, malignant tumor,thyroid disease and homorne drug use;
- a history of related drug allergy;
- alcohol or drug misuse;
- pregnant, breast-feeding or intending to become pregnant.
Key Trial Info
Start Date :
May 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06217887
Start Date
May 10 2020
End Date
June 1 2024
Last Update
January 23 2024
Active Locations (1)
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1
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China, 210008