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

NCT03910361 | Completed Phase 4

• 1 other identifier: DA1229_NAFLD_IV
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 7

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

Conditions

Type2 Diabetes; Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Changes from baseline intrahepatic fat (%)

  Changes from baseline intrahepatic fat (%) after treatment with evogliptin or pioglitazone

  24 weeks

Study Arms (2)

Evogliptin

EXPERIMENTAL

evogliptin 5mg

Drug: Evogliptin

Pioglitazone

ACTIVE COMPARATOR

pioglitazone 15mg

Drug: Pioglitazone

Interventions

Evogliptin DRUG

evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd

Also known as: Suganon

Evogliptin

Pioglitazone DRUG

pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd

Also known as: Gluconon

Pioglitazone

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (7)

Samsung Medical Center

Changwon, South Korea

Location

Soonchunhyang University Hospital

Cheonan, South Korea

Location

Keimyung Dongsan University Medical Center

Daegu, South Korea

Location

Hanyang University Guri Hospital

Guri-si, South Korea

Location

Catholic University of Seoul ST.Mary's Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one; Pioglitazone

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Byung Wan Lee

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: April 12, 2019
• Primary Completion: July 2, 2020
• Study Completion: July 2, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

KR (7)