type 2 diabetes
Conditions
Interventions
Experimental group:standard treatment + Henagliflozin,10mg Qd, oral
control group:standard treatment
Sponsors
Peking University People's Hospital/The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with T2DM aged >= 18 years; 2. 7.0% <= HbA1c <= 11% (local test value); 3. 30mg/g <= UACR <= 5000mg/g, and duration over 3 months (local test value); 4. Steady dose of ACEi or ARB for 4 weeks or more (no significant change in dose); 5. Signed and dated written ICF.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women and women of childbearing age who do not want to use reliable contraception; 2. Known allergy to Henagliflozin; 3. Type I diabetes; 4. T2DM with history of ketoacidosis (DKA) within the last 6 months; 5. eGFR = 160 mmHg and/or diastolic blood pressure >= 100 mmHg at screening visit (Mean of three blood pressure measurements in supine position)); 10. Symptomatic hypotension and/or systolic blood pressure < 90 mmHg at visit 0 or visit 1, or hypovolemia; 11. Current use or prior use of a SGLT-2i or GLP-1RA or MRA within 3 months; 12. Life expectancy is less than 1 year during the screening period; 13. Diagnosed malignant tumors; 14. Patients with a history of recurrent urinary and reproductive tract infections (clinician's judgment); 15. Patients participating in other clinical trials within 3 months; 16. Further exclusion criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in UACR from baseline ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in eGFR from baseline ;Changes in eGFR slope from baseline ;Changes in uric acid from baseline ;The composite incidence of sustained eGFR decrease of >= 50%, end-stage renal disease (kidney dialysis time = 90 days, kidney transplantation, sustained eGFR<15 ml/min/1.73 m2), and nephrotic death within 24 weeks ;Changes in HbA1c from baseline ;Changes in weight from baseline;Changes in waist circumference from baseline;Changes in blood lipids from baseline;Changes in blood pressure from baseline;Changes in the number of antihypertensive drugs from baseline;Changes in blood potassium, sodium, phosphorus, and calcium from baseline; | — |
Countries
China
Contacts
Public ContactLinong Ji/ Zhiguang Zhou
Peking University People's Hospital/The Second Xiangya Hospital of Central South University
Outcome results
None listed