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

April 27, 2021 updated by: Dong-A ST Co., Ltd.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Changwon, Korea, Republic of
        • Samsung Medical Center
      • Cheonan, Korea, Republic of
        • Soonchunhyang University Hospital
      • Daegu, Korea, Republic of
        • Keimyung Dongsan University Medical Center
      • Guri-si, Korea, Republic of
        • Hanyang University Guri Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Catholic University of Seoul St.Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evogliptin
evogliptin 5mg
Drug: Evogliptin
evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd
Other Names:
  • Suganon
Active Comparator: Pioglitazone
pioglitazone 15mg
Drug: Pioglitazone
pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd
Other Names:
  • Gluconon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline intrahepatic fat (%)
Time Frame: 24 weeks
Changes from baseline intrahepatic fat (%) after treatment with evogliptin or pioglitazone
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Investigators

  • Principal Investigator: Byung Wan Lee, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2019

Primary Completion (Actual)

July 2, 2020

Study Completion (Actual)

July 2, 2020

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (Actual)

April 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA1229_NAFLD_IV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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