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

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called dorzagliatin may help improve kidney function in people with type 2 diabetes. If you or a family member has type 2 diabetes and meets specific health criteria, you might be eligible to participate in this study. To qualify, participants need to be between 18 and 75 years old, have a certain level of kidney function, and their blood sugar levels must fall within a specific range.

During the trial, participants will receive dorzagliatin and will be monitored to see how their kidney function changes before and after taking the medication. The study is not yet recruiting participants, but it aims to gather important information that could help improve treatment for those facing kidney issues related to diabetes. If you have any questions about your eligibility or the trial itself, it’s a good idea to discuss them with your healthcare provider.

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.