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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 468
- 主要终点
- UACR
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
SGLT2i + Finerenone + Dulaglutide group
Participants in the intervention group will receive dulaglutide added to their ongoing stable-dose SGLT2 inhibitor and finerenone therapy
干预措施: Dulaglutide (Drug)
SGLT2i + Finerenone + Dulaglutide group
Participants in the intervention group will receive dulaglutide added to their ongoing stable-dose SGLT2 inhibitor and finerenone therapy
干预措施: SGLT2i (Drug)
SGLT2i + Finerenone group
Participants continue current stable-dose SGLT2 inhibitor plus finerenone therapy without addition of dulaglutide
干预措施: SGLT2i (Drug)
SGLT2i + Finerenone + Dulaglutide group
Participants in the intervention group will receive dulaglutide added to their ongoing stable-dose SGLT2 inhibitor and finerenone therapy
干预措施: Finerenone (Drug)
SGLT2i + Finerenone group
Participants continue current stable-dose SGLT2 inhibitor plus finerenone therapy without addition of dulaglutide
干预措施: Finerenone (Drug)
结局指标
主要结局
UACR
时间窗: Change in UACR from baseline at Week 26
Urine Albumin-to-Creatinine Ratio（UACR）
时间窗: Change in UACR from baseline at Week 26
次要结局
- eGFR(Change from baseline at Week 13 and Week 26)
- eGFR slope(Change from baseline at Week 13 and Week 26)
- HbA1c(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)
- lipid profile(Change from baseline at Week 13 and Week 26)
- estimated Glomerular Filtration Rate(eGFR)(Change from baseline at Week 13 and Week 26)
- Hemoglobin A1c(HbA1c)(Change from baseline at Week 13 and Week 26)