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

Официальное название

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

Обзор

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).

Вмешательства

• Препарат Dulaglutide
  Dulaglutide 1.5 mg, once weekly
• Препарат SGLT2i
  administered according to prescribing information
• Препарат Finerenone
  administered according to prescribing information

Первичные конечные точки

• Urine Albumin-to-Creatinine Ratio（UACR） [Срок оценки: Change in UACR from baseline at Week 26]

Вторичные конечные точки (6)

• estimated Glomerular Filtration Rate(eGFR) [Срок оценки: Change from baseline at Week 13 and Week 26]
• eGFR slope [Срок оценки: Change from baseline at Week 13 and Week 26]
• Hemoglobin A1c(HbA1c) [Срок оценки: Change from baseline at Week 13 and Week 26]
• weight [Срок оценки: Change from baseline at Week 13 and Week 26]
• lipid profile [Срок оценки: Change from baseline at Week 13 and Week 26]
• serum creatinine [Срок оценки: Change from baseline at Week 13 and Week 26]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07537088 · 2026-ethics-58

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗