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

Yan Bi

Status: Not yet enrolling

Conditions: Diabetic Nephropathy Type 2

Treatments: Drug: Gliclazide; Drug: Dorzagliatin

Study type: Interventional

Funder types: Other

Identifiers

NCT06222476

BY2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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106 participants in 2 patient groups

Patients treat with Dorzagliatin

Experimental group

Description:

Dorzagliatin will be initiated and maintained at 75mg twice a day until the completion of the study. Meanwhile, all patients will also continue on regimen of metformin 500mg three times a day throughout the study. Visits at 4-week intervals will be performed to evaluate the safety of drugs.

Treatment:

Drug: Dorzagliatin

Patients treat with Gliclazide

Active Comparator group

Description:

Gliclazide will be initiated and maintained at 30mg once a day until the completion of the study. Meanwhile, all patients will also continue on regimen of metformin 500mg three times a day throughout the study. Visits at 4-week intervals will be performed to evaluate the safety of drugs.

Treatment:

Drug: Gliclazide