Back to resultsEfficacy and Safety of Evoglitin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases
Primary Purpose
Type2 Diabetes, Non-Alcoholic Fatty Liver Disease
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Evogliptin
Pioglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Type2 Diabetes
Eligibility 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
Sites / Locations
- Samsung Medical Center
- Soonchunhyang University Hospital
- Keimyung Dongsan University Medical Center
- Hanyang University Guri Hospital
- Catholic University of Seoul ST.Mary's Hospital
- Seoul National University Hospital
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Evogliptin
Pioglitazone
Arm Description
evogliptin 5mg
pioglitazone 15mg
Outcomes
Primary Outcome Measures
Changes from baseline intrahepatic fat (%)
Changes from baseline intrahepatic fat (%) after treatment with evogliptin or pioglitazone
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03910361
Brief Title
Efficacy and Safety of Evoglitin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 12, 2019 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
July 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
Evogliptin 5mg Group: Administration with Evogliptin 5mg and Placebo for 24weeks
Pioglitazone 15mg Group: Administration with Pioglitazone 15mg and Placebo for 24weeks
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Non-Alcoholic Fatty Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evogliptin
Arm Type
Experimental
Arm Description
evogliptin 5mg
Arm Title
Pioglitazone
Arm Type
Active Comparator
Arm Description
pioglitazone 15mg
Intervention Type
Drug
Intervention Name(s)
Evogliptin
Other Intervention Name(s)
Suganon
Intervention Description
evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Other Intervention Name(s)
Gluconon
Intervention Description
pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd
Primary Outcome Measure Information:
Title
Changes from baseline intrahepatic fat (%)
Description
Changes from baseline intrahepatic fat (%) after treatment with evogliptin or pioglitazone
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung Wan Lee
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Changwon
Country
Korea, Republic of
Facility Name
Soonchunhyang University Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
Keimyung Dongsan University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri-si
Country
Korea, Republic of
Facility Name
Catholic University of Seoul ST.Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Evoglitin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases
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