Effect of Dorzagliatin on Renal Function Outcomes in People With Type 2 Diabetes: a Multicentric, Prospective, Randomized Study.
Launched by YAN BI · Jan 16, 2024
Trial Information
Current as of March 27, 2025
Not yet recruiting
Keywords
ClinConnect Summary
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 activating glucokinase and is not affected by the patient's renal function. However, previous studies of this drug have rarely involved studies that improve markers related to renal function. On the one hand, in this study, changes of renal function (eGFR, creatinine, cystatin C, TNF-1) are collected to investigate whether dorzagliatin is benefit to kidney. On the other hand, renal magnetic resona...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age:18-75 years old, male and female.
- • 2. 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).
- • 3. UACR 30-299mg/g.
- • 4. eGFR ≥60mL/min/1.73m².
- • 5. HbA1c 7.0-10.5%.
- Exclusion Criteria:
- • 1. Pregnant and lactating women and women of childbearing age who do not want to take reliable contraceptive measures.
- • 2. Known allergic history to dorzagliatin/gliclazide/metformin.
- • 3. Diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or hypoglycemic coma, etc.
- • 4. Serious impairment of heart, liver, kidney and other organs.
- • 5. With hypertension(≥140/90mmHg).
- • 6. Fasting C-peptide \<300pmol/L.
- • 7. Contraindications of MRI examination, such as implantation of metal prosthesis in vivo, claustrophobia, wearing insulin pumps, etc.
About Yan Bi
Yan Bi is a leading clinical trial sponsor dedicated to advancing innovative healthcare solutions through rigorous research and development. With a commitment to enhancing patient outcomes, Yan Bi specializes in the design and execution of clinical trials across various therapeutic areas, leveraging cutting-edge technologies and methodologies. The organization prioritizes collaboration with healthcare professionals and regulatory bodies to ensure the highest standards of safety and efficacy in its studies. Yan Bi's mission is to contribute to the global biopharmaceutical landscape by bringing new treatments to market that address unmet medical needs.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nanjing, Jiangsu, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0