Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease

NCT07537088 | Not Yet Recruiting Phase 4

• 1 other identifier: 2026-ethics-58
• Study Type: interventional
• Target: 468
• Locations: 0 countries
• Sites: N/A

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).

Conditions

T2DM (Type 2 Diabetes Mellitus); CKD - Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Urine Albumin-to-Creatinine Ratio（UACR）

  Change in UACR from baseline at Week 26

Secondary Outcomes (6)

• estimated Glomerular Filtration Rate(eGFR)

  Change from baseline at Week 13 and Week 26

• eGFR slope

  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

  Change from baseline at Week 13 and Week 26

Other Outcomes (2)

• composite kidney outcome

  From enrollment to the end of treatment at week 26

• composite cardiovascular outcome

  From enrollment to the end of treatment at week 26

Study Arms (2)

SGLT2i + Finerenone + Dulaglutide group

EXPERIMENTAL

Participants in the intervention group will receive dulaglutide added to their ongoing stable-dose SGLT2 inhibitor and finerenone therapy

Drug: Dulaglutide; Drug: SGLT2i; Drug: Finerenone

SGLT2i + Finerenone group

ACTIVE COMPARATOR

Participants continue current stable-dose SGLT2 inhibitor plus finerenone therapy without addition of dulaglutide

Drug: SGLT2i; Drug: Finerenone

Interventions

Dulaglutide DRUG

Dulaglutide 1.5 mg, once weekly

SGLT2i + Finerenone + Dulaglutide group

SGLT2i DRUG

administered according to prescribing information

SGLT2i + Finerenone + Dulaglutide group; SGLT2i + Finerenone group

Finerenone DRUG

administered according to prescribing information

SGLT2i + Finerenone + Dulaglutide group; SGLT2i + Finerenone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD)
• Hemoglobin A1c (HbA1c) 7.0%-11%
• Urine albumin-to-creatinine ratio (UACR) 300-5000 mg/g
• Body mass index (BMI) 21-45 kg/m²
• 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)
• 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 qualify if:

• Pregnant or lactating women, or women of childbearing potential unwilling to use reliable contraception
• History of definite contraindications or intolerance to glucagon-like peptide-1 receptor agonists (GLP-1RA), SGLT2 inhibitors, or finerenone
• Type 1 diabetes
• History of diabetic ketoacidosis (DKA) within the past 6 months
• Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²
• 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
• Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg (mean of three supine measurements) during screening
• Symptomatic hypotension and/or systolic blood pressure \<90 mmHg at screening, or patients judged by the investigator to have hypovolemia
• Serum potassium \>5.0 mmol/L at screening
• Current use or use within 3 months prior to screening of GLP-1 receptor agonists or other mineralocorticoid receptor antagonists (e.g., spironolactone)
• 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)
• History of recurrent urinary tract or genital infections (as judged by the investigator)
• Life expectancy \<1 year at screening
• Confirmed malignancy
• Participation in another clinical trial within 3 months prior to screening

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

dulaglutide; finerenone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jialin Gao

CONTACT

0553-5739315; gaojialin-ktz@wnmc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04