T2DM with CKD
Conditions
Interventions
Control group:SGLT2i+finerenone
Experimental group:Dulaglutide
Sponsors
Yijishan Hospital of Wannan Medical college
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Inclusion Criteria (Subjects must meet all the following criteria to enter the study) : (1) T2DM patients with chronic kidney disease aged >=18 years old (2) 7.0%<=HbA1c<=11% (local test value) (3) 300mg/g<=UACR<=5000mg/g (local test value) (4) 21kg/m^2<=BMI<=45kg/m^2 (5) SGLT2i combined with finerenone therapy for more than 3 months on the basis of maximum tolerated dose of renin-angiotensin system inhibitor (RASi) (6) Voluntarily sign the informed consent form before the start of the trial-related activities, understand the procedures and methods of the trial, and are willing to strictly abide by the clinical trial protocol
Exclusion criteria
Exclusion criteria: 2. Exclusion Criteria (Subjects were excluded from the study if they met any of the following criteria) : (1) pregnant, lactating women, and women of childbearing age who are unwilling to use reliable contraception (2) a history of clear contraindications or intolerance to GLP-1 receptor agonists, SGLT-2 inhibitors, or finerenone (3) patients with type 1 diabetes mellitus (4) type 2 diabetes mellitus with a history of ketoacidosis (DKA) within the past 6 months (5) eGFR =160mmHg and/or diastolic blood pressure >=100 mmHg during the screening visit (mean of three blood pressure measurements in the supine position) (8) symptomatic hypotension and/or screening systolic blood pressure 5.0 mmol/L during screening Current use or use within 3 months of a GLP-1 receptor agonist or other mineralocorticoid receptor antagonist (e.g., spironolactone) (11) patients who are receiving or have clear clinical indications for systemic immunosuppressive therapy (including but not limited to prednisone, cyclosporine, etc.) due to other renal diseases (e.g., primary or secondary glomerulonephritis, lupus nephritis, etc.) (12) patients with a history of recurrent urinary and genital tract infections (clinician judgment) (13) life expectancy during the screening period was less than 1 year (14) patients with confirmed malignant tumors (15) patients who participated in other clinical trials within 3 months (16) patients other than those described above who were judged by the investigator to be ineligible to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UACR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Four items of blood lipids (TC, TG, LDL-C, HDL-C);Weight;Serum Creatinine;HbA1c;eGFR;eGFR Slope; | — |
Countries
China
Contacts
Public ContactJialin Gao
Yijishan Hospital of Wannan Medical college
Outcome results
None listed