Type 2 Diabetes Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 135 |
Est. completion date | December 31, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes of urine markers | Urinalysis will be performed at all visit days | baseline, week 12, week 24 | |
Other | Changes of bone health | parathyroid hormone, 25-hydroxylated vitamin will be measured at all visit days | baseline, week 12, week 24 | |
Other | Changes of gut microbiota | gut microbiota composition, microbiota related to metabolic dysfunction | baseline, week 24 | |
Primary | Changes of HbA1c level | Patients achieving the target level | baseline, week 12, week 24 | |
Primary | Changes of CAP score | Controlled Attenuation Parameter (CAP) score by transient elastography | baseline, week 24 | |
Secondary | Changes of LSM score | Liver stiffness measurement (LSM) score by transient elastography | baseline, week 24 | |
Secondary | Changes of noninvasive liver fibrosis markers | Noninvasive liver fibrosis markers will be calculated at baseline and at the end of the study | baseline, week 12, week 24 | |
Secondary | Changes of body weight and body composition | Body composition by bioelectrical impedance will be measured at baseline and at the end of the study | baseline, week 24 | |
Secondary | Changes of lipid levels | Cholesterol level will be measured at all visit days | baseline, week 12, week 24 | |
Secondary | Changes of ketone levels | Ketone level will be measured at all visit days | baseline, week 12, week 24 | |
Secondary | Changes of liver parenchyma by ultrasonography | improvement or deterioration | baseline, week 24 | |
Secondary | Changes of liver function parameters | Liver enzymes, albumin will be measured at all visit days. | baseline, week 12, week 24 | |
Secondary | Changes of liver fibrosis biomarkers | Type IV collagen | baseline, week 24 | |
Secondary | Changes of inflammation biomarker | high-sensitivity CRP | baseline, week 24 |
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