The purpose of this study is to evaluate whether adding dulaglutide to the combination therapy of Sodium-Glucose Co-Transporter 2 Inhibitors(SGLT2i) and finerenone can provide additional kidney protection and safety for Chinese adults with Type 2 Diabetes Mellitus(T2DM) and Chronic Kidney Disease(CKD). Eligible participants will be adults with T2DM and mild-to-moderate CKD who have been receiving SGLT2 inhibitor plus finerenone for at least 3 months on the basis of maximum tolerated dose of renin-angiotensin system inhibitor (RASi). Participants will be randomly assigned to either continue the original regimen or to receive add-on therapy with dulaglutide.The study will last for 26 weeks, with participants required to attend scheduled visits for efficacy and safety assessments at Week 13 (±1 week) and Week 26 (±1 week, final visit).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
468
Dulaglutide 1.5 mg, once weekly
administered according to prescribing information
administered according to prescribing information
Urine Albumin-to-Creatinine Ratio(UACR)
Time frame: Change in UACR from baseline at Week 26
estimated Glomerular Filtration Rate(eGFR)
Chronic Kidney Disease Epidemiology Collaboration Equation(CKD-EPI) Formula
Time frame: Change from baseline at Week 13 and Week 26
eGFR slope
the change in eGFR per unit of time
Time frame: Change from baseline at Week 13 and Week 26
Hemoglobin A1c(HbA1c)
Time frame: Change from baseline at Week 13 and Week 26
weight
Time frame: Change from baseline at Week 13 and Week 26
lipid profile
Total Cholesterol(TC), Triglyceride(TG), Low-Density Lipoprotein Cholesterol(LDL-C), High-Density Lipoprotein Cholesterol(HDL-C)
Time frame: Change from baseline at Week 13 and Week 26
serum creatinine
Time frame: Change from baseline at Week 13 and Week 26
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