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NCT03910361 Clinical Trial

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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03910361
Other study ID # DA1229_NAFLD_IV
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 12, 2019
Est. completion date July 2, 2020

Study information
Verified date April 2021
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date July 2, 2020
Est. primary completion date July 2, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Evogliptin
evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd
• Pioglitazone
pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Changwon
Korea, Republic of Soonchunhyang University Hospital Cheonan
Korea, Republic of Keimyung Dongsan University Medical Center Daegu
Korea, Republic of Hanyang University Guri Hospital Guri-si
Korea, Republic of Catholic University of Seoul ST.Mary's Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes from baseline intrahepatic fat (%) Changes from baseline intrahepatic fat (%) after treatment with evogliptin or pioglitazone 24 weeks
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