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

Phase 4

Completed

• Conditions: Type2 Diabetes; Non-Alcoholic Fatty Liver Disease
• Interventions: Drug: Evogliptin; Drug: Pioglitazone

• Registration Number: NCT03910361
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief 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

Detailed Description

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

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

Study Timeline

• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Study Start: 2019-04-12
• Primary Completion: 2020-07-02
• Study Completion: 2020-07-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evogliptin	Evogliptin	evogliptin 5mg
Pioglitazone	Pioglitazone	pioglitazone 15mg

Primary Outcome Measures

Name	Time	Method
Changes from baseline intrahepatic fat (%)	24 weeks	Changes from baseline intrahepatic fat (%) after treatment with evogliptin or pioglitazone

Trial Locations

Locations (7)

Soonchunhyang University Hospital; 🇰🇷 Cheonan, Korea, Republic of

Hanyang University Guri Hospital; 🇰🇷 Guri-si, Korea, Republic of

Samsung Medical Center; 🇰🇷 Changwon, Korea, Republic of

Catholic University of Seoul ST.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Keimyung Dongsan University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of