T2DM (Type 2 Diabetes Mellitus), CKD - Chronic Kidney Disease
Conditions
Brief summary
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).
Interventions
DRUGDulaglutide
Dulaglutide 1.5 mg, once weekly
DRUGSGLT2i
administered according to prescribing information
DRUGFinerenone
administered according to prescribing information
Sponsors
First Affiliated Hospital of Wannan Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine Albumin-to-Creatinine Ratio（UACR） | Change in UACR from baseline at Week 26 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| estimated Glomerular Filtration Rate(eGFR) | Change from baseline at Week 13 and Week 26 | Chronic Kidney Disease Epidemiology Collaboration Equation(CKD-EPI) Formula |
| eGFR slope | Change from baseline at Week 13 and Week 26 | the change in eGFR per unit of time |
| Hemoglobin A1c(HbA1c) | Change from baseline at Week 13 and Week 26 | — |
| weight | Change from baseline at Week 13 and Week 26 | — |
| lipid profile | Change from baseline at Week 13 and Week 26 | Total Cholesterol(TC), Triglyceride(TG), Low-Density Lipoprotein Cholesterol(LDL-C), High-Density Lipoprotein Cholesterol(HDL-C) |
| serum creatinine | Change from baseline at Week 13 and Week 26 | — |
Contacts
CONTACTJialin Gao
Outcome results
None listed