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

Y

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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