Novel Antidiabetic Medications and Their Effect on Liver Steatosis (NAMELS-18)

What this study is testing ClinicalTrials.gov NCT05946148 ↗

Description as written by the study sponsor.

The goal of this clinical study is to compare the therapeutic effect of Dulaglutide and Empagliflozin in patients with Diabetes Mellitus type 2 and Non-Alcoholic Fatty Liver Disease. The main question it aims to answer is: Is there a beneficial effect regarding liver steatosis in patients receiving either of these 2 medications and which is more effective? Patients will undergo shearwave elastography, magnetic resonance imaging, and ultrasound. Furthermore, calculation of the Fatty Liver Index (FLI), the Fibrosis-4 Index (FIB-4), as well as the Aspartate Aminotransferase to Platelet ratio Index (APRI) and the NAFLD Fibrosis Score (NFS) will be performed. Researchers will compare 3 groups: Group 1 will receive oral Empagliflozin, as add-on to their previous treatment regimen, for 52 weeks. Group 2 will receive subcutaneous Dulaglutide, as add-on to their previous treatment regimen, for 52 weeks. Group 3 will receive other optimal antidiabetic treatment (apart from agents of the GLP1-ras or SGLT2-is families) for 52 weeks.

Treatments tested

• Empagliflozin also known as E Drug

  Empagliflozin 10mg daily, as add-on to previous treatment regimen.

• Dulaglutide also known as D Drug

  Dulaglutide 1.5mg weekly, as add-on to previous treatment regimen

• Control Rx also known as C Drug

  Optimal anti-diabetic treatment excluding agents of the GLP1-ras or SGLT2-is families.