Efficacy and Safety of Evoglitin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases

A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases

A multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of evogliptin in patients with type 2 diabetes and non-alcoholic fatty liver diseases

1. Evogliptin 5mg Group: Administration with Evogliptin 5mg and Placebo for 24weeks
2. Pioglitazone 15mg Group: Administration with Pioglitazone 15mg and Placebo for 24weeks

Inclusion Criteria:

• Type II diabetes mellitus
• Subjects who have not been taking any oral hypoglycemic agent within 8 weeks from screening or who have been taking metformin monotherapy at the same dose for more than 8 weeks before screening
• Subjects with 6.5%≤HbA1c≤9.0% at screening
• Subjects with 20kg/m2≤BMI≤40kg/m2 at screening

Exclusion Criteria:

• Type I diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
• AST > upper normal range*3
• Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Subjects who experienced hypersensitivity reaction against DPP-4 inhibitors, thiazolidinediones
• Pregnant women