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

• Status: Completed
• Trial end date: 2020-07-02
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Pioglitazone

Criteria

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