Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Treatments: Dulaglutide; Empagliflozin; Immunoglobulin Fc Fragments

Criteria

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