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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGLT2i + Finerenone + Dulaglutide group | Experimental | Participants in the intervention group will receive dulaglutide added to their ongoing stable-dose SGLT2 inhibitor and finerenone therapy |
|
| SGLT2i + Finerenone group | Active Comparator | Participants continue current stable-dose SGLT2 inhibitor plus finerenone therapy without addition of dulaglutide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dulaglutide | Drug | Dulaglutide 1.5 mg, once weekly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Urine Albumin-to-Creatinine Ratio(UACR) | Change in UACR from baseline at Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| estimated Glomerular Filtration Rate(eGFR) | Chronic Kidney Disease Epidemiology Collaboration Equation(CKD-EPI) Formula | Change from baseline at Week 13 and Week 26 |
| eGFR slope | the change in eGFR per unit of time |
| Measure | Description | Time Frame |
|---|---|---|
| composite kidney outcome | the first occurrence of any component of the composite outcome, which comprised sustained eGFR decline ≥30%, end-stage kidney disease (maintenance dialysis ≥90 days, kidney transplantation, or sustained eGFR <15 mL/min/1.73 m²), or death from kidney disease | From enrollment to the end of treatment at week 26 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jialin Gao | Contact | 0553-5739315 | gaojialin-ktz@wnmc.edu.cn |
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| SGLT2i |
| Drug |
administered according to prescribing information |
|
| Finerenone | Drug | administered according to prescribing information |
|
| Change from baseline at Week 13 and Week 26 |
| Hemoglobin A1c(HbA1c) | Change from baseline at Week 13 and Week 26 |
| weight | 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) | Change from baseline at Week 13 and Week 26 |
| serum creatinine | Change from baseline at Week 13 and Week 26 |
| composite cardiovascular outcome |
the first occurrence of any component of the composite outcome, which comprised non-fatal myocardial infarction, non-fatal stroke, and death from cardiovascular causes or unknown causes |
| From enrollment to the end of treatment at week 26 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C555680 | dulaglutide |
| C576501 | finerenone |
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