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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
135
Empagliflozin 10 mg p.o. once daily (available to control over \~25mg)
Dulaglutide 0.75mg s.c. once a week (available to control over \~1.5mg)
Empagliflozin 10 mg p.o. once daily with Dulaglutide 0.75mg s.c. once weekly
Changes of HbA1c level
Patients achieving the target level
Time frame: baseline, week 12, week 24
Changes of CAP score
Controlled Attenuation Parameter (CAP) score by transient elastography
Time frame: baseline, week 24
Changes of LSM score
Liver stiffness measurement (LSM) score by transient elastography
Time frame: baseline, week 24
Changes of noninvasive liver fibrosis markers
Noninvasive liver fibrosis markers will be calculated at baseline and at the end of the study
Time frame: baseline, week 12, week 24
Changes of body weight and body composition
Body composition by bioelectrical impedance will be measured at baseline and at the end of the study
Time frame: baseline, week 24
Changes of lipid levels
Cholesterol level will be measured at all visit days
Time frame: baseline, week 12, week 24
Changes of ketone levels
Ketone level will be measured at all visit days
Time frame: baseline, week 12, week 24
Changes of liver parenchyma by ultrasonography
improvement or deterioration
Time frame: baseline, week 24
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Changes of liver function parameters
Liver enzymes, albumin will be measured at all visit days.
Time frame: baseline, week 12, week 24
Changes of liver fibrosis biomarkers
Type IV collagen
Time frame: baseline, week 24
Changes of inflammation biomarker
high-sensitivity CRP
Time frame: baseline, week 24