A Multicentric, Prospective, Randomized Study Evaluating the Improvement of Renal Function Outcomes With Dorzagliatin in Patients With Type 2 Diabetes Mellitus With Early Kidney Injury.

BY2023

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.

2024-02-20

2025-05-31

2026-06-30

Not yet recruiting

106

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 106, 'type': 'ESTIMATED'}}

2024-01-24