Type 2 diabetes
Conditions
Interventions
ARB+SGLT-2i group:Losartan 50mg qd combined with Henagliflozein 5mg qd
ARB+MRA group:Losartan 50mg qd combined with Finerenone 10mg qd
ARB+MRA+SGLT-2i group:Losartan 50mg qd in combination with Finerenone 10mg qd and Henagliflozein 5mg qd
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes patients 2. Age 18-70 years old 3. Patients with clinically diagnosed diabetes nephropathy, and eGFR 45~90 mL/min/1.73m2, UACR 30~300mg/g 4. At the initial visit, serum potassium = 4.8mmol/L 5. Voluntary signing of informed consent form
Exclusion criteria
Exclusion criteria: 1. Patients with any of the following medical and surgical history: a. Known major non diabetes nephropathy, including clinically relevant renal artery stenosis b. Uncontrolled hypertension, with average sitting systolic blood pressure (SBP) = 170mmHg or average sitting diastolic blood pressure (DBP) = 110mmHg at the initial visit, or with average sitting systolic blood pressure = 160mmHg or average sitting DBP = 100mmHg at the follow-up visit c. Mean systolic blood pressure at initial diagnosis or follow-up<90mmHg d. Clinical diagnosis of chronic heart failure with reduced ejection fraction and persistent symptoms e. Stroke, transient ischemic attack, acute coronary syndrome, or hospitalization due to worsening heart failure within 30 days prior to enrollment f. = 12 weeks before enrollment due to acute kidney failure undergoing dialysis/kidney transplant/planned kidney transplant within the next six months g. Addison's disease h. Liver insufficiency, Child-Pugh C-type i. Allergies to active ingredients or any excipients 2. Patients receiving any of the following medication treatments: Apply SGLT-2i inhibitor 3 months before enrollment (stop at least 6 months before randomization) b. Used in combination with epridone, spironolactone, any renin inhibitors or potassium sparing diuretics, and cannot be discontinued 4 weeks prior to enrollment c. Simultaneous treatment with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers (stopped at least 7 days before randomization) 3. Patients who meet any of the following conditions: a. Any other disease or treatment that makes the patient unsuitable for this study and does not allow participation throughout the planned study period (such as malignant tumors, critical organ failure, or other diseases that limit life expectancy to less than 12 months) b. Pregnancy, breastfeeding, or intention to conceive during the study period c. Previous (= 30 days prior to randomization) or concurrent participation in another clinical study using investigational drugs d. Patients with communication barriers who cannot fully understand or cooperate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary microalbumin creatinine ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| estimated glomerular filtration rate;Serum potassium; | — |
Countries
China
Contacts
Public ContactLi Ang
Peking University First Hospital
Outcome results
None listed