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

Sponsor
First Affiliated Hospital of Wannan Medical College
Study ID
NCT07537088
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • CKD - Chronic Kidney Disease
  • T2DM (Type 2 Diabetes Mellitus)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
468 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SGLT2i + Finerenone + Dulaglutide group
    Participants in the intervention group will receive dulaglutide added to their ongoing stable-dose SGLT2 inhibitor and finerenone therapy
  • Active Comparator: SGLT2i + Finerenone group
    Participants continue current stable-dose SGLT2 inhibitor plus finerenone therapy without addition of dulaglutide

Primary Outcome Measure

Urine Albumin-to-Creatinine Ratio（UACR） [ Time Frame: Change in UACR from baseline at Week 26 ]

Central Contacts

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