Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D
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
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:
|
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:
|
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:
|
Outcome Measures
Primary Outcome Measures
- Changes of HbA1c level [baseline, week 12, week 24]
Patients achieving the target level
- Changes of CAP score [baseline, week 24]
Controlled Attenuation Parameter (CAP) score by transient elastography
Secondary Outcome Measures
- Changes of LSM score [baseline, week 24]
Liver stiffness measurement (LSM) score by transient elastography
- 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
- 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
- Changes of lipid levels [baseline, week 12, week 24]
Cholesterol level will be measured at all visit days
- Changes of ketone levels [baseline, week 12, week 24]
Ketone level will be measured at all visit days
- Changes of liver parenchyma by ultrasonography [baseline, week 24]
improvement or deterioration
- Changes of liver function parameters [baseline, week 12, week 24]
Liver enzymes, albumin will be measured at all visit days.
- Changes of liver fibrosis biomarkers [baseline, week 24]
Type IV collagen
- Changes of inflammation biomarker [baseline, week 24]
high-sensitivity CRP
Other Outcome Measures
- Changes of urine markers [baseline, week 12, week 24]
Urinalysis will be performed at all visit days
- Changes of bone health [baseline, week 12, week 24]
parathyroid hormone, 25-hydroxylated vitamin will be measured at all visit days
- Changes of gut microbiota [baseline, week 24]
gut microbiota composition, microbiota related to metabolic dysfunction
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age 20 or over
-
uncontrolled HbA1c (7~10%) with metformin and/or sulfonylurea
-
Hepatic steatosis estimated by Fibroscan (CAP ≥258 dB/m)
-
MAFLD: presence of any conditions
-
Overweight or obese: BMI ≥23 kg/m2 (Asian)
-
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
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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:
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Significant alcohol consumption
-
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
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Type 1 diabetes mellitus
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medication usage within 3 months: vitamin E, PUFA, UDCA, fish oil, SGLT2 inhibitors, GLP1-RAs, TZDs
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Severe organ dysfunction
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liver damage: AST/ALT >x5 UNL, albumin <3.2, platelet <60k, Child-Pugh-Turcotte stage B or C
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kidney damage: serum creatinine ≥2.0 mg/dL or eGFR <50 mL/min/1.72m2
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Hepatocellular carcinoma, active tumor, or metastasis
-
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.- MAFLD_empa_dula