Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D
NCT ID: NCT05140694
Last Updated: 2022-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
135 participants
INTERVENTIONAL
2023-12-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Empagliflozin
Empagliflozin 10mg p.o. once daily (available to control over \~25mg)
Empagliflozin
Empagliflozin 10 mg p.o. once daily (available to control over \~25mg)
Dulaglutide
Dulaglutide 0.75mg s.c. once weekly (available to control over \~1.5mg)
Dulaglutide
Dulaglutide 0.75mg s.c. once a week (available to control over \~1.5mg)
Empagliflozin and Dulagludie
Empagliflozin 10mg p.o. once daily and dulaglutide 0.75mg s.c. once weekly
Empagliflozin and Dulaglutide
Empagliflozin 10 mg p.o. once daily with Dulaglutide 0.75mg s.c. once weekly
Interventions
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Empagliflozin
Empagliflozin 10 mg p.o. once daily (available to control over \~25mg)
Dulaglutide
Dulaglutide 0.75mg s.c. once a week (available to control over \~1.5mg)
Empagliflozin and Dulaglutide
Empagliflozin 10 mg p.o. once daily with Dulaglutide 0.75mg s.c. once weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
90 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Soo Lim
Professor
Principal Investigators
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Soo Lim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Central Contacts
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Other Identifiers
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MAFLD_empa_dula
Identifier Type: -
Identifier Source: org_study_id
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