Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dulaglutide, SGLT2i, Finerenone.
- Who it may be relevant to
- Registry conditions: T2DM (Type 2 Diabetes Mellitus), CKD - Chronic Kidney Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug Dulaglutide
Dulaglutide 1.5 mg, once weekly - Drug SGLT2i
administered according to prescribing information - Drug Finerenone
administered according to prescribing information
Primary outcome measures
- Urine Albumin-to-Creatinine Ratio（UACR） [Time frame: Change in UACR from baseline at Week 26]
Secondary outcome measures (6)
- estimated Glomerular Filtration Rate(eGFR) [Time frame: Change from baseline at Week 13 and Week 26]
- eGFR slope [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 [Time frame: Change from baseline at Week 13 and Week 26]
- serum creatinine [Time frame: Change from baseline at Week 13 and Week 26]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07537088 · 2026-ethics-58