Effect of Dorzagliatin on Renal Function Outcomes in People With Type 2 Diabetes: a Multicentric, Prospective, Randomized Study.
- Conditions
- Diabetic Nephropathy Type 2
- Interventions
- Registration Number
- NCT06222476
- Lead Sponsor
- Yan Bi
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 106
- 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%.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Patients treat with Dorzagliatin 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. Patients treat with Gliclazide 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.
- Primary Outcome Measures
Name Time Method Participants' personal information 1 day Self-reported information (age in years, gender，course of disease )
Physical assessments 1 day BMI (body mass index) in kg/m\^2
renal function 1 day changes of renal function (eGFR, creatinine, cystatin C, TNF-1)
renal magnetic resonance imaging(MRI) 1 day Changes of perirenal fat content, renal proton density fat fraction and degree of renal fibrosis
- Secondary Outcome Measures
Name Time Method HOMA2-IR 1 day fasting blood sugar（mmol/L）\*fasting insulin（mIU/L）/22.5
HOMA2-IS 1 day 22.5/fasting blood sugar（mmol/L）\*fasting insulin（mIU/L）
HOMA2-β 1 day 20\*fasting insulin（mIU/L）/（fasting blood sugar（mmol/L）-3.5）
blood sugar 1 day fasting blood sugar、2-hour postprandial blood sugar
insulin 1 day fasting insulin、2-hour insulin
Trial Locations
- Locations (1)
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
🇨🇳Nanjing, Jiangsu, China