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 Dulaglutide, SGLT-2 Inhibitors, and Finerenone Triple Therapy in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease: A Multicenter, Prospective, Randomized Controlled Study

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 Overview

• Status: Not yet recruiting
• Conditions: T2DM (Type 2 Diabetes Mellitus); CKD - Chronic Kidney Disease
• Intervention / Treatment: Drug: Dulaglutide; Drug: SGLT2i; Drug: Finerenone

• Study Type: Interventional
• Enrollment (Estimated): 468
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jialin Gao; Phone Number: 0553-5739315; Email: gaojialin-ktz@wnmc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SGLT2i + Finerenone + Dulaglutide group; Participants in the intervention group will receive dulaglutide added to their ongoing stable-dose SGLT2 inhibitor and finerenone therapy	Drug: Dulaglutide; Dulaglutide 1.5 mg, once weekly; Drug: SGLT2i; administered according to prescribing information; Drug: Finerenone; administered according to prescribing information
Active Comparator: SGLT2i + Finerenone group; Participants continue current stable-dose SGLT2 inhibitor plus finerenone therapy without addition of dulaglutide	Drug: SGLT2i; administered according to prescribing information; Drug: Finerenone; administered according to prescribing information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urine Albumin-to-Creatinine Ratio（UACR）	Change in UACR from baseline at Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eGFR slope	the change in eGFR per unit of time	Change from baseline at Week 13 and Week 26
weight		Change from baseline at Week 13 and Week 26
serum creatinine		Change from baseline at Week 13 and Week 26
estimated Glomerular Filtration Rate(eGFR)	Chronic Kidney Disease Epidemiology Collaboration Equation(CKD-EPI) Formula	Change from baseline at Week 13 and Week 26
Hemoglobin A1c(HbA1c)		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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wannan Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; finerenone; dulaglutide
• Other Study ID Numbers: 2026-ethics-58

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No