Trial · Interventional
Not yet recruitingPhase 4Registry dataEfficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease
Overview
- Status
- Not yet recruiting
- Phase
- Phase 4
- Enrollment
- 468 participants (estimated)
- Sponsor
- First Affiliated Hospital of Wannan Medical College · Other
- Design
- Randomized · Open label (no masking)
- Countries
- Not stated
- Start
- May 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Completion
- Jul 2027 (estimated)
- First posted
- 17 Apr 2026
- Last update posted
- 22 Apr 2026
- Conditions
- T2DM (Type 2 Diabetes Mellitus) · CKD - Chronic Kidney Disease
Timeline
1 trial · 1 not yet recruiting
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease
NCT07537088est. May 2026 to est. Jul 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Interventions
- DulaglutideDrug
- SGLT2iDrug
- FinerenoneDrug
Arms2
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 outcomes1
Outcomes the sponsor listed as primary.
Urine Albumin-to-Creatinine Ratio(UACR)
Time frame · Change in UACR from baseline at Week 26
Secondary outcomes(6)
estimated Glomerular Filtration Rate(eGFR)
Time frame · Change from baseline at Week 13 and Week 26
Registry description
Chronic Kidney Disease Epidemiology Collaboration Equation(CKD-EPI) Formula
eGFR slope
Time frame · Change from baseline at Week 13 and Week 26
Registry description
the change in eGFR per unit of time
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
lipid profile
Time frame · Change from baseline at Week 13 and Week 26
Registry description
Total Cholesterol(TC), Triglyceride(TG), Low-Density Lipoprotein Cholesterol(LDL-C), High-Density Lipoprotein Cholesterol(HDL-C)
serum creatinine
Time frame · Change from baseline at Week 13 and Week 26
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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