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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Participants' personal information
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age:18-75 years old, male and female.
- •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).
- •UACR 30-299mg/g.
- •eGFR ≥60mL/min/1.73m².
- •HbA1c 7.0-10.5%.
Exclusion Criteria
- •Pregnant and lactating women and women of childbearing age who do not want to take reliable contraceptive measures.
- •Known allergic history to dorzagliatin/gliclazide/metformin.
- •Diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or hypoglycemic coma, etc.
- •Serious impairment of heart, liver, kidney and other organs.
- •With hypertension(≥140/90mmHg).
- •Fasting C-peptide <300pmol/L.
- •Contraindications of MRI examination, such as implantation of metal prosthesis in vivo, claustrophobia, wearing insulin pumps, etc.
Arms & Interventions
Patients treat with Dorzagliatin
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.
Intervention: Dorzagliatin (Drug)
Patients treat with Gliclazide
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.
Intervention: Gliclazide (Drug)
Outcomes
Primary Outcomes
Participants' personal information
Time Frame: 1 day
Self-reported information (age in years, gender，course of disease )
Physical assessments
Time Frame: 1 day
BMI (body mass index) in kg/m\^2
renal function
Time Frame: 1 day
changes of renal function (eGFR, creatinine, cystatin C, TNF-1)
renal magnetic resonance imaging(MRI)
Time Frame: 1 day
Changes of perirenal fat content, renal proton density fat fraction and degree of renal fibrosis
Secondary Outcomes
- blood sugar(1 day)
- insulin(1 day)
- HOMA2-IR(1 day)
- HOMA2-IS(1 day)
- HOMA2-β(1 day)
Investigators
Yan Bi
Chief Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School