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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03910361
Recruitment Status : Completed
First Posted : April 10, 2019
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Study Description
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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

Condition or disease Intervention/treatment Phase
Type2 Diabetes Non-Alcoholic Fatty Liver Disease Drug: Evogliptin Drug: Pioglitazone Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 12, 2019
Actual Primary Completion Date : July 2, 2020
Actual Study Completion Date : July 2, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Evogliptin
evogliptin 5mg
 Drug: Evogliptin
evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd
Other Name: Suganon
Active Comparator: Pioglitazone
pioglitazone 15mg
 Drug: Pioglitazone
pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd
Other Name: Gluconon


Outcome Measures
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Primary Outcome Measures :
  1. Changes from baseline intrahepatic fat (%) [ Time Frame: 24 weeks ]
    Changes from baseline intrahepatic fat (%) after treatment with evogliptin or pioglitazone


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910361


Locations
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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, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
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Principal Investigator: Byung Wan Lee Severance Hospital
More Information
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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT03910361    
Other Study ID Numbers: DA1229_NAFLD_IV
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs