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Trial · Interventional

Status unknownPhase 4Registry data

Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D

NCTNCT05140694 (opens ClinicalTrials.gov in a new tab)Other idMAFLD_empa_dula
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
135 participants (estimated)
Sponsor
Seoul National University Bundang Hospital · Other
Design
Randomized · Double masking
Countries
Not stated
Start
1 Dec 2023 (estimated)
Primary completion
30 Jun 2024 (estimated)
Completion
31 Dec 2025 (estimated)
First posted
1 Dec 2021
Last update posted
4 Oct 2022
Conditions
Metabolic-associated Fatty Liver Disease · Type 2 Diabetes

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 4

    Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D

    NCT05140694

    est. 1 Dec 2023 to est. 31 Dec 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The co-administration of SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on glycemic control in subjects with type 2 diabetes mellitus and MAFLD better than empagliflozin or dulaglutide alone. The SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on fatty liver disease in subjects with type 2 diabetes mellitus and MAFLD.

Interventions

  • EmpagliflozinDrug
  • DulaglutideDrug
  • Empagliflozin and DulaglutideDrug

Arms3

  • Experimental

    Empagliflozin

    Empagliflozin 10mg p.o. once daily (available to control over \~25mg)

  • Experimental

    Dulaglutide

    Dulaglutide 0.75mg s.c. once weekly (available to control over \~1.5mg)

  • Experimental

    Empagliflozin and Dulagludie

    Empagliflozin 10mg p.o. once daily and dulaglutide 0.75mg s.c. once weekly

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Changes of HbA1c level

    Time frame · baseline, week 12, week 24

    Registry description

    Patients achieving the target level

  2. Changes of CAP score

    Time frame · baseline, week 24

    Registry description

    Controlled Attenuation Parameter (CAP) score by transient elastography

Secondary outcomes(9)

  1. Changes of LSM score

    Time frame · baseline, week 24

    Registry description

    Liver stiffness measurement (LSM) score by transient elastography

  2. Changes of noninvasive liver fibrosis markers

    Time frame · baseline, week 12, week 24

    Registry description

    Noninvasive liver fibrosis markers will be calculated at baseline and at the end of the study

  3. Changes of body weight and body composition

    Time frame · baseline, week 24

    Registry description

    Body composition by bioelectrical impedance will be measured at baseline and at the end of the study

  4. Changes of lipid levels

    Time frame · baseline, week 12, week 24

    Registry description

    Cholesterol level will be measured at all visit days

  5. Changes of ketone levels

    Time frame · baseline, week 12, week 24

    Registry description

    Ketone level will be measured at all visit days

  6. Changes of liver parenchyma by ultrasonography

    Time frame · baseline, week 24

    Registry description

    improvement or deterioration

  7. Changes of liver function parameters

    Time frame · baseline, week 12, week 24

    Registry description

    Liver enzymes, albumin will be measured at all visit days.

  8. Changes of liver fibrosis biomarkers

    Time frame · baseline, week 24

    Registry description

    Type IV collagen

  9. Changes of inflammation biomarker

    Time frame · baseline, week 24

    Registry description

    high-sensitivity CRP

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 20 Years up to 90 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. age 20 or over 2. uncontrolled HbA1c (7\~10%) with metformin and/or sulfonylurea 3. Hepatic steatosis estimated by Fibroscan (CAP ≥258 dB/m) 4. MAFLD: presence of any conditions 1. Overweight or obese: BMI ≥23 kg/m2 (Asian) 2. Metabolic dysregulation: at least of two of following criteria * Waist circumference: ≥90/80 cm in men and women (Asian) * Blood pressure ≥130/85 mmHg or drug treatment * Plasma triglycerides ≥150 mg/dL or drug treatment * Plasma HDL-cholesterol \<40/50 mg/dL for men and women or drug treatment * Prediabetes (i.e. fasting glucose levels 100 to 125 mg/dL or 2-hour post-load glucose levels 140 to 199 mg/dL or HbA1c 5.7% to 6.4% * HOMA-insulin resistance score ≥2.5 * Plasma high-sensitivity CRP \>2 mg/L Exclusion Criteria: 1. Significant alcohol consumption 2. Other competing causes for hepatic steatosis: viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1 anti-trypsin deficiency, Celiac disease, Overt hypothyroidism, other secondary causes 3. Type 1 diabetes mellitus 4. medication usage within 3 months: vitamin E, PUFA, UDCA, fish oil, SGLT2 inhibitors, GLP1-RAs, TZDs 5. Severe organ dysfunction 1. liver damage: AST/ALT \>x5 UNL, albumin \<3.2, platelet \<60k, Child-Pugh-Turcotte stage B or C 2. kidney damage: serum creatinine ≥2.0 mg/dL or eGFR \<50 mL/min/1.72m2 6. Hepatocellular carcinoma, active tumor, or metastasis 7. End-stage liver disease

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