Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05140694
Collaborator
(none)
135
3
46

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Active-comparator Controlled, Parallel-group Study, to Evaluate the Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With Type 2 Diabetes Mellitus
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Empagliflozin

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

Drug: Empagliflozin
Empagliflozin 10 mg p.o. once daily (available to control over ~25mg)
Other Names:
  • Jardiance
  • Experimental: Dulaglutide

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

    Drug: Dulaglutide
    Dulaglutide 0.75mg s.c. once a week (available to control over ~1.5mg)
    Other Names:
  • Trulicity
  • Experimental: Empagliflozin and Dulagludie

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

    Drug: Empagliflozin and Dulaglutide
    Empagliflozin 10 mg p.o. once daily with Dulaglutide 0.75mg s.c. once weekly
    Other Names:
  • Jardiance and Trulicity
  • Outcome Measures

    Primary Outcome Measures

    1. Changes of HbA1c level [baseline, week 12, week 24]

      Patients achieving the target level

    2. Changes of CAP score [baseline, week 24]

      Controlled Attenuation Parameter (CAP) score by transient elastography

    Secondary Outcome Measures

    1. Changes of LSM score [baseline, week 24]

      Liver stiffness measurement (LSM) score by transient elastography

    2. Changes of noninvasive liver fibrosis markers [baseline, week 12, week 24]

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

    3. Changes of body weight and body composition [baseline, week 24]

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

    4. Changes of lipid levels [baseline, week 12, week 24]

      Cholesterol level will be measured at all visit days

    5. Changes of ketone levels [baseline, week 12, week 24]

      Ketone level will be measured at all visit days

    6. Changes of liver parenchyma by ultrasonography [baseline, week 24]

      improvement or deterioration

    7. Changes of liver function parameters [baseline, week 12, week 24]

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

    8. Changes of liver fibrosis biomarkers [baseline, week 24]

      Type IV collagen

    9. Changes of inflammation biomarker [baseline, week 24]

      high-sensitivity CRP

    Other Outcome Measures

    1. Changes of urine markers [baseline, week 12, week 24]

      Urinalysis will be performed at all visit days

    2. Changes of bone health [baseline, week 12, week 24]

      parathyroid hormone, 25-hydroxylated vitamin will be measured at all visit days

    3. Changes of gut microbiota [baseline, week 24]

      gut microbiota composition, microbiota related to metabolic dysfunction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    5. Overweight or obese: BMI ≥23 kg/m2 (Asian)

    6. 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

    6. liver damage: AST/ALT >x5 UNL, albumin <3.2, platelet <60k, Child-Pugh-Turcotte stage B or C

    7. kidney damage: serum creatinine ≥2.0 mg/dL or eGFR <50 mL/min/1.72m2

    8. Hepatocellular carcinoma, active tumor, or metastasis

    9. End-stage liver disease

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Seoul National University Bundang Hospital

    Investigators

    • Principal Investigator: Soo Lim, MD, PhD, Seoul National University Bundang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Soo Lim, Professor, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT05140694
    Other Study ID Numbers:
    • MAFLD_empa_dula
    First Posted:
    Dec 1, 2021
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 6, 2022