Diabetic Nephropathy Type 2
Conditions
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.
Interventions
DRUGDorzagliatin
Dorzagliatin will be initiated and maintained at 75mg twice a day
DRUGGliclazide
Gliclazide will be initiated and maintained at 30mg once a day
Sponsors
Yan Bi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| blood sugar | 1 day | fasting blood sugar、2-hour postprandial blood sugar |
| HOMA2-IS | 1 day | 22.5/fasting blood sugar（mmol/L）\*fasting insulin（mIU/L） |
| insulin | 1 day | fasting insulin、2-hour insulin |
| HOMA2-β | 1 day | 20\*fasting insulin（mIU/L）/（fasting blood sugar（mmol/L）-3.5） |
| HOMA2-IR | 1 day | fasting blood sugar（mmol/L）\*fasting insulin（mIU/L）/22.5 |
Countries
China
Outcome results
None listed