[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634238":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":35,"locations":27,"responsibleParty":41,"collaborators":27,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":27,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":27,"enrollmentInfo":52,"targetDuration":27,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":27,"overallStatus":62,"whyStopped":27,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":27},{"fullName":5,"class":6},"First Affiliated Hospital of Wannan Medical College","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"SGLT2i + Finerenone + Dulaglutide group","EXPERIMENTAL","Participants in the intervention group will receive dulaglutide added to their ongoing stable-dose SGLT2 inhibitor and finerenone therapy",[13,14,15],"Drug: Dulaglutide","Drug: SGLT2i","Drug: Finerenone",{"label":17,"type":18,"description":19,"interventionNames":20},"SGLT2i + Finerenone group","ACTIVE_COMPARATOR","Participants continue current stable-dose SGLT2 inhibitor plus finerenone therapy without addition of dulaglutide",[14,15],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Dulaglutide","Dulaglutide 1.5 mg, once weekly",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"SGLT2i","administered according to prescribing information",[9,17],{"type":23,"name":33,"description":30,"armGroupLabels":34,"otherNames":27},"Finerenone",[9,17],[36],{"name":37,"role":38,"phone":39,"phoneExt":27,"email":40},"Jialin Gao","CONTACT","0553-5739315","gaojialin-ktz@wnmc.edu.cn",{"type":42,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100634238","phase-4-efficacy-and-safety-of-triple-therapy-with-dulaglutide-sglt2-inhibitors-and-finerenone-in-chinese-adults-with-type-2-diabetes-and-chronic-kidney-disease-100634238",false,"NCT07537088","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","Inclusion Criteria:\n\n* 1.Patients aged ≥18 years with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD)\n* 2.Hemoglobin A1c (HbA1c) 7.0%-11%\n* 3.Urine albumin-to-creatinine ratio (UACR) 300-5000 mg\u002Fg\n* 4.Body mass index (BMI) 21-45 kg\u002Fm²\n* 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)\n* 6.Sign the informed consent, understand the procedures and methods of this trial and willing to strictly comply with the clinical trial protocol\n\nExclusion Criteria:\n\n* 1.Pregnant or lactating women, or women of childbearing potential unwilling to use reliable contraception\n* 2.History of definite contraindications or intolerance to glucagon-like peptide-1 receptor agonists (GLP-1RA), SGLT2 inhibitors, or finerenone\n* 3.Type 1 diabetes\n* 4.History of diabetic ketoacidosis (DKA) within the past 6 months\n* 5.Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m²\n* 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\n* 7.Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg (mean of three supine measurements) during screening\n* 8.Symptomatic hypotension and\u002For systolic blood pressure \\\u003C90 mmHg at screening, or patients judged by the investigator to have hypovolemia\n* 9.Serum potassium \\>5.0 mmol\u002FL at screening\n* 10.Current use or use within 3 months prior to screening of GLP-1 receptor agonists or other mineralocorticoid receptor antagonists (e.g., spironolactone)\n* 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)\n* 12.History of recurrent urinary tract or genital infections (as judged by the investigator)\n* 13.Life expectancy \\\u003C1 year at screening\n* 14.Confirmed malignancy\n* 15.Participation in another clinical trial within 3 months prior to screening\n* 16.Any other condition judged by the investigator as unsuitable for participation in this clinical trial.","ALL","18 Years",{"count":53,"type":54},468,"ESTIMATED","INTERVENTIONAL",[57],"PHASE4","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).",[60,61],"T2DM (Type 2 Diabetes Mellitus)","CKD - Chronic Kidney Disease","NOT_YET_RECRUITING","2026-04-17",{"date":65,"type":66},"2026-04-22","ACTUAL",{"date":68,"type":54},"2026-05",{"date":70,"type":54},"2027-07",{"name":5,"class":6}]