Clareo Health | Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease
Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease
First Affiliated Hospital of Wannan Medical College
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1.Patients aged ≥18 years with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD)
2.Hemoglobin A1c (HbA1c) 7.0%-11%
3.Urine albumin-to-creatinine ratio (UACR) 300-5000 mg/g
4.Body mass index (BMI) 21-45 kg/m²
5.Having received combination therapy with SGLT2 inhibitor and finerenone for 3 months or longer, on the basis of maximum tolerated dose of renin-angiotensin system inhibitor (RASi)
6.Sign the informed consent, understand the procedures and methods of this trial and willing to strictly comply with the clinical trial protocol
You may not be if
1.Pregnant or lactating women, or women of childbearing potential unwilling to use reliable contraception
2.History of definite contraindications or intolerance to glucagon-like peptide-1 receptor agonists (GLP-1RA), SGLT2 inhibitors, or finerenone
3.Type 1 diabetes
4.History of diabetic ketoacidosis (DKA) within the past 6 months
5.Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²
6.Hospitalization within 30 days prior to screening for acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery
7.Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg (mean of three supine measurements) during screening
8.Symptomatic hypotension and/or systolic blood pressure \<90 mmHg at screening, or patients judged by the investigator to have hypovolemia
9.Serum potassium \>5.0 mmol/L at screening
10.Current use or use within 3 months prior to screening of GLP-1 receptor agonists or other mineralocorticoid receptor antagonists (e.g., spironolactone)
11.Patients receiving or with clear clinical indications requiring systemic immunosuppressive therapy (including but not limited to prednisone, cyclosporine, etc.) for other kidney diseases (e.g., primary or secondary glomerulonephritis, lupus nephritis)
12.History of recurrent urinary tract or genital infections (as judged by the investigator)
13.Life expectancy \<1 year at screening
14.Confirmed malignancy
15.Participation in another clinical trial within 3 months prior to screening
16.Any other condition judged by the investigator as unsuitable for participation in this clinical trial.
