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Trial · Interventional

Not yet recruitingPhase 4Registry data

Efficacy 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
202620272028
  1. 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

    NCT07537088

    est. 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.

  1. Urine Albumin-to-Creatinine Ratio(UACR)

    Time frame · Change in UACR from baseline at Week 26

Secondary outcomes(6)
  1. 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

  2. eGFR slope

    Time frame · Change from baseline at Week 13 and Week 26

    Registry description

    the change in eGFR per unit of time

  3. Hemoglobin A1c(HbA1c)

    Time frame · Change from baseline at Week 13 and Week 26

  4. weight

    Time frame · Change from baseline at Week 13 and Week 26

  5. 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)

  6. 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
Inclusion Criteria: * 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 Exclusion Criteria: * 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.

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