NCT07537088Not yet recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 468 (estimated)
- First submitted
- 12 Apr 2026
- Start date
- May 2026
- Primary completion date
- Apr 2027
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT07537088
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 468
- From May 2026 to the primary completion date, Apr 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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)
- 15.Participation in another clinical trial within 3 months prior to screening
Other illness
- 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
- 7.Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg (mean of three supine measurements) during screening
- 12.History of recurrent urinary tract or genital infections (as judged by the investigator)
- 14.Confirmed malignancy
- 16.Any other condition judged by the investigator as unsuitable for participation in this clinical trial.
Lab values
- 5.Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²
- 9.Serum potassium \>5.0 mmol/L at screening
Other
- 1.Pregnant or lactating women, or women of childbearing potential unwilling to use reliable contraception
- 8.Symptomatic hypotension and/or systolic blood pressure \<90 mmHg at screening, or patients judged by the investigator to have hypovolemia
- 13.Life expectancy \<1 year at screening
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.