drugset / Trial / NCT03646292

Antidiabetic Drugs for Steatotic Liver Disease

NCT03646292

Phase 4 Completed 51 enrolled Yonsei University
RandomizedParallel-groupOpen-labelTreatment

Summary

To investigate the synergic therapeutic effect of thiazolidinediones and SGLT2 inhibitor on metabolic dysfunction-associated steatotic liver disease, the effect of empagliflozin 10mg, pioglitazone 15mg monotherapy and combination therapy in patients with type 2 diabetes and steatotic liver disease will be compared and analyzed. This study was designed to include a total of 60 patients (20 per subgroup) for randomized controlled trials with prospective, open label, randomized, single-institution clinical trials. The drug will be maintained for a total of 24 weeks. The primary endpoint is the difference of liver fat change measured by MRI-PDFF in the largest possible polygonal region of interest encompassing both lobes of the liver between three groups.

Timeline

Start
2018-12-06
Primary completion
2022-06-16
Completion
2022-06-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Empagliflozin Small molecule 10 mg
Subject Pioglitazone Small molecule 15 mg