About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Crossover
Treatments tested in this trial
Dorzagliatin
DrugDorzagliatin will be initiated and maintained at 75mg twice a day
Gliclazide
DrugGliclazide will be initiated and maintained at 30mg once a day
Treatment groups
Trial outcomes
Primary outcomes
Participants' personal information
Self-reported information (age in years, gender,course of disease )
Physical assessments
BMI (body mass index) in kg/m\^2
renal function
changes of renal function (eGFR, creatinine, cystatin C, TNF-1)
renal magnetic resonance imaging(MRI)
Changes of perirenal fat content, renal proton density fat fraction and degree of renal fibrosis
Secondary outcomes
blood sugar
fasting blood sugar、2-hour postprandial blood sugar
insulin
fasting insulin、2-hour insulin
HOMA2-β
20\*fasting insulin(mIU/L)/(fasting blood sugar(mmol/L)-3.5)
HOMA2-IR
fasting blood sugar(mmol/L)\*fasting insulin(mIU/L)/22.5
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yan Bi
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: