Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes
Prospective, Multicenter, Randomized, and Comparative Clinical Trials to Compare the Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes
1 other identifier
interventional
28
1 country
4
Brief Summary
An exploratory comparison of changes in liver fibrosis through glycemic control within and between groups after administration of Pioglitazone and Evogliptin in chronic hepatitis B patients with type 2 diabetes and liver fibrosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2020
Typical duration for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2020
CompletedFirst Submitted
Initial submission to the registry
July 18, 2022
CompletedFirst Posted
Study publicly available on registry
July 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2023
CompletedJuly 26, 2022
July 1, 2022
2.3 years
July 18, 2022
July 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in Liver Stiffness Measurement at 24 weeks compared to baseline.
It is measured based on the CAP score(db/m) and kilopascal from the liver fibroscan and evaluated by performing the paired-sample t-test or Wilcoxon signed test.
24 weeks
Secondary Outcomes (10)
Changes in Controlled Attenuation Parameter(CAP) value at 24 weeks compared to baseline.
24 weeks
Changes in HbA1c at 24 weeks compared to baseline.
24 weeks
Changes in Insulin at 24 weeks compared to baseline.
24 weeks
Changes in lipid profile at 24 weeks compared to baseline.
24 weeks
Changes in aspartate aminotransferase(AST)/alanine aminotransferase(ALT) at 24 weeks compared to baseline.
24 weeks
- +5 more secondary outcomes
Study Arms (2)
Pioglitazone 15mg
EXPERIMENTALpioglitazone hydrochloride. PO. 2 tablets once a day.
Evogliptin 5mg
EXPERIMENTALEvogliptin tartrate. PO. 1 tablets once a day.
Interventions
Eligibility Criteria
You may qualify if:
- Adult aged 20 or over and under 80 years of age
- Those who satisfy the following conditions among chronic hepatitis B patients diagnosed with type 2 diabetes.
- first. For the first diagnosis of type 2 diabetes: 6.5% ≤ HbA1c \< 10.0%; second. Diagnosed with type 2 diabetes: HbA1c \< 10.0%;
- Subjects who show significant liver fibrosis of 7 kilopascal or more in liver elasticity test using Fibroscan.
- Subjects who voluntarily sign the informed consent form after understanding the clinical study and being informed of the risks and benefits.
You may not qualify if:
- Those who are currently taking Pioglitazone or Evogliptin, or those who have stopped taking medication for less than 4 weeks.
- Patients meeting the criteria for alcoholic fatty liver (if alcohol intake exceeds 210 g per week for men and 140 g per week for women for the past 2 years)
- Cirrhosis patients with decreased liver function (CTP class B and C)
- Those taking drugs that can cause fatty liver (amiodarone, methotrexate, tamoxifen, valproate, corticosteroids, etc.)
- Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis (within 24 weeks)
- In case of allergy or hypersensitivity reaction to the target drug or its components.
- Patients treated with oral or parenteral corticosteroids chronically (\>14 consecutive days) within 8 weeks prior to screening
- Malnutrition, starvation, and debilitating conditions (including patients with severe infections and severe trauma before and after surgery)
- Patients receiving or receiving radiation and chemotherapy for malignancy for less than 2 years.
- Heart failure (class III-IV in New York Heart Association classification) or uncontrolled arrhythmias within 24 weeks
- table. New York Heart Association Classification. Class I: Normal athletic ability; Class Ⅱ: Difficulty breathing, palpitations, chest pain, etc. appear due to daily exercise (fast walking or climbing a hill); Class Ⅲ: Symptoms appear with light exercise (walking on flat ground); Class IV: Symptoms appear even at rest;
- Patients with acute cardiovascular disease within 12 weeks (patients with a history of unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or coronary intervention)
- Patients with renal failure, chronic renal disease (estimated glomerular filtration rate \<60 mL/min/1.73 m2) or patients on dialysis.
- Anemic patients with an Hb level of less than 10.5 g/dl.
- Pregnant or lactating women
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung Up Kimlead
Study Sites (4)
Gangnam Severance Hospital
Seoul, South Korea
Samsung seoul Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung Up Kim
Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
July 18, 2022
First Posted
July 26, 2022
Study Start
September 18, 2020
Primary Completion
January 19, 2023
Study Completion
February 19, 2023
Last Updated
July 26, 2022
Record last verified: 2022-07