NCT06222476

Effect of Dorzagliatin on Renal Function Outcomes in People With Type 2 Diabetes: a Multicentric, Prospective, Randomized Study.

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Yan Bi · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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 resonance imaging(MRI) results are analysed to explore the differences among control subjects and patients treated with dorzagliatin.

Conditions

• Diabetic Nephropathy Type 2

Interventions

Type	Name	Description
DRUG	Dorzagliatin	Dorzagliatin will be initiated and maintained at 75mg twice a day
DRUG	Gliclazide	Gliclazide will be initiated and maintained at 30mg once a day

Timeline

• Start date: 2024-02-20
• Primary completion: 2025-05-31
• Completion: 2026-06-30
• First posted: 2024-01-24
• Last updated: 2024-01-24

Locations

1 site across 1 country: China