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

ConditionsT2DM (Type 2 Diabetes Mellitus)CKD - 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

468 Participants

are divided into 2 treatment groups

Group A: SGLT2i + Finerenone + Dulaglutide groupExperimental treatment 3 interventions

Group B: SGLT2i + Finerenone groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

Urine Albumin-to-Creatinine Ratio（UACR）

Time frame

Change in UACR from baseline at Week 26

Secondary outcomes

estimated Glomerular Filtration Rate(eGFR)

Chronic Kidney Disease Epidemiology Collaboration Equation(CKD-EPI) Formula

Time frame

Change from baseline at Week 13 and Week 26

eGFR slope

the change in eGFR per unit of time

Time frame

Change from baseline at Week 13 and Week 26

Hemoglobin A1c(HbA1c)

Time frame

Change from baseline at Week 13 and Week 26

weight

Time frame

Change from baseline at Week 13 and Week 26

Other outcomes

composite kidney outcome

the first occurrence of any component of the composite outcome, which comprised sustained eGFR decline ≥30%, end-stage kidney disease (maintenance dialysis ≥90 days, kidney transplantation, or sustained eGFR \<15 mL/min/1.73 m²), or death from kidney disease

Time frame

From enrollment to the end of treatment at week 26

composite cardiovascular outcome

the first occurrence of any component of the composite outcome, which comprised non-fatal myocardial infarction, non-fatal stroke, and death from cardiovascular causes or unknown causes

Time frame

From enrollment to the end of treatment at week 26

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Wannan Medical College

Lead sponsor

Source ClinicalTrials.gov

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