Status:
NOT_YET_RECRUITING
Effect of Dorzagliatin on Renal Function Outcomes in People With Type 2 Diabetes: a Multicentric, Prospective, Randomized Study.
Lead Sponsor:
Yan Bi
Conditions:
Diabetic Nephropathy Type 2
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The main purpose of this study is to explore the improvement of renal function before and after the intervention of dorzagliatin in patients with type 2 diabetes.
Detailed Description
As soon，metformin、SGLT-2i、GLP-1RA have been confirmed to have protective effect on the kidneys in the statement of consensus at home and abroad. Dorzagliatin exerts a potent hypoglycemic effect by act...
Eligibility Criteria
Inclusion
- Age:18-75 years old, male and female.
- Patients with type 2 diabetes mellitus, type 2 diabetes mellitus diagnosis criteria: according to the "Chinese Type 2 Diabetes Mellitus Prevention and Treatment Guide (2020 Edition).
- UACR 30-299mg/g.
- eGFR ≥60mL/min/1.73m².
- HbA1c 7.0-10.5%.
Exclusion
- Pregnant and lactating women and women of childbearing age who do not want to take reliable contraceptive measures.
- Known allergic history to dorzagliatin/gliclazide/metformin.
- Diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or hypoglycemic coma, etc.
- Serious impairment of heart, liver, kidney and other organs.
- With hypertension(≥140/90mmHg).
- Fasting C-peptide \<300pmol/L.
- Contraindications of MRI examination, such as implantation of metal prosthesis in vivo, claustrophobia, wearing insulin pumps, etc.
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06222476
Start Date
February 20 2024
End Date
June 30 2026
Last Update
January 24 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China, 210008