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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Wannan Medical College

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dulaglutide
  • SGLT2i
  • Finerenone

Treatment groups

468 Participants
are divided into 2 treatment groups

Locations

This trial has no locations