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

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

The clinical study determines the effect of Evogliptin in patients with type 2 diabetes mellitus and chronic hepatitis B to confirm the improvement of hepatic fibrosis.

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes
• Intervention / Treatment: Drug: gluconon tab 15mg; Drug: suganon tab 5mg

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Seung Up Kim; Phone Number: +82-2228-1982; Email: ksukorea@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Seoul National University Hospital
    • Contact: Su jong Yu; Phone Number: 82-2-2072-2228; Email: ydoctor2@hanmail.net
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Gangnam Severance Hospital
    • Contact: Jung il Lee; Phone Number: 82-10-2218-9331; Email: mdflorence@yuhs.ac
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Hospital
    • Contact: Won seok Kang; Phone Number: 82-10-8750-5033; Email: wonseok1202.kang@samsung.com
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Yonsei Severance Hospital
    • Contact: Seung Up Kim; Phone Number: +82-2228-1982; Email: ksukorea@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adultes between 20 and 80 years of age

• Patients who satisfy the following conditions among chronic hepatitis B patients diagnosed with type 2 diabetes

  1. Patients who are newly diagnosed as type 2 diabetes : 6.5% ≤ HbA1c < 10.0%
  2. Patients who are already diagnosed as type 2 diabetes: HbA1c < 10.0%
• Patients who have significant liver fibrosis of at least 7 kPa in a hepaticity test using fibroscan
• Patients who voluntarily signed the consent form after informed on the object, method, benefits and risks of the clinical study

Exclusion Criteria:

• Patients who were taking Pioglitazone or Evoglipitin medication or who took diabetes medication within 4 weeks at the time
• Patients who meet the standard of alcoholic fatty liver (in excess of 210g per week for men and 140g per week for women over the last two years)
• Liver cirrhosis patients with impaired liver function (CTP class B and C)
• Patients who took drugs that can cause fatty liver (amiodarone, methotrexate, tamoxifen, valproate, corticosteroids, etc.)
• Patients with acute or chronic metabolic acidosis with or without coma and history of ketonic acid (within 24 weeks)
• Allergic or hypersensitive to the target drug or its composition;
• Patients treated with oral or non - oral corticosteroid treatment for chronic (more than 14 consecutive days) within 8 weeks prior to screening.
• Poor nutrition, starvation, and debilitating conditions (including severe infections and severe injury patients before and after surgery)
• Patients who are receiving radiation and chemotherapy for malignant tumors or patients who have been on chemotherapy or radiation treatment for less than two years.
• Patients with heart failure in 24 weeks (class III to IV in NYHA classification) or unregulated arrhythmia.
• Patients with acute cardiovascular disease in 12 weeks or less (e.g. unstable angina, myocardial infarction, routine ischemic seizures, cerebrovascular disease, coronary bypass surgery, or coronary artery interventions).
• Patients with renal failure, chronic neuropathy (estimated glomerular filtration rate <60 mL/min/1.73 m2) or dialysis
• Anemia patients whose Hb levels are less than 10.5g/dl
• Women who are pregnant or breastfeeding
• Patients who do not agree to use proper contraception during clinical trials only for women or men.
• Patients who took medicines for clinical trials in other clinical trials within four weeks of document consent
• Patients who are unable to participate in clinical trials on the judgment of other researchers
• Patients who cannot read the consent form (e.g. illiteracy, foreigners, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pioglitazone	Drug: gluconon tab 15mg; frosting and formulation : a round, convex tablet of white to gray. path of administration : once a day, two tabs, oral Amount of raw material medication (1 pill) : Pioglitazone hydrochloride 16.53mg storage method : Store 15 to 30°C to avoid light-tight containers and moisture manufacturing source : DONG-A ST
EXPERIMENTAL: Evogliptin	Drug: suganon tab 5mg; frosting and formulation : pink circular film coating tablets path of administration : once a day, one tabs, oral Amount of raw material medication (1 pill) : Evogliptin tartrate 6.869mg(5mg as evogliptin) storage method : Confidential containers, stored at room temperature (1-30°C) manufacturing source : DONG-A ST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days)	Changes in the Liver Stiffness measurement after 24 weeks (±7days) compared to Baseline within and between arms	Baseline
Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days)	Changes in the Liver Stiffness measurement after 24 weeks (±7days) compared to Baseline within and between arms	Baseline to 24 weeks (±7days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline CAP (Controlled Attenuation Parameter) at week 24 (±7days) within and between arms	Change from baseline at Week 24 (±7days) is defined as [(Baseline CAP value) - (Follow-up CAP value)] / (Baseline CAP value) * 100 (%)	1) Baseline, 2) Baseline to 24 weeks (±7days)
Changes from baseline HbA1c at week 24 (±7days) within and between arms	Change from baseline at Week 24 (±7days) is defined as HbA1c at Week 24 (±7days) minus HbA1c at Week 0	1) Baseline, 2) Baseline to 24 weeks (±7days)
Changes from baseline Insulin at week 24 (±7days) within and between arms	Change from baseline at Week 24 (±7days) is defined as insulin at Week 24 (±7days) minus insulin at Week 0	1) Baseline, 2) Baseline to 24 weeks (±7days)
Changes from baseline lipid profile (total cholesterol, HDL, LDL, TG) at week 24 (±7days) within and between arms	Change from baseline at Week 24 (±7days) is defined as lipid profile (total cholesterol, HDL, LDL, TG) at Week 24 (±7days) minus lipid profile at Week 0	1) Baseline, 2) Baseline to 24 weeks (±7days)
Changes from baseline AST/ALT at week 24 (±7days) within and between arms	Change form baseline at Week 24 (±7days) is defined as the proportion of AST/ALT values who are normalized at Week 24 (±7days)	1) Baseline, 2) Baseline to 24 weeks (±7days)
Changes from baseline Body weight at week 24 (±7days) within and between arms	Change from baseline at Week 24 (±7days) is defined as body weight at Week 24 minus body weight at Week 0	1) Baseline, 2) Baseline to 24 weeks (±7days)
Changes from baseline Liver fibrosis and fatty liver at week 24 (±7days) among the MRE+MRI PDFF enforcement arms within and between arms	Change from baseline at Week 24 (±7days) is defined by MRE+MRI PDFF	1) Baseline, 2) Baseline to 24 weeks (±7days)
Proportions of adverse effects and drug interruptions or changes between baseline and week 24 (±7days) within and between arms	Compare between baseline at Week 24 (±7days) is defined as the occurrence rate of adverse events and drug interruptions or changes	1) Baseline, 2) Baseline to 24 weeks (±7days)
Prognostic factor of the Improvement of Liver fibrosis between baseline and week 24 (±7days) within and between arms	Prediction Factor Analysis of the Improvement of Liver fibrosis after 24 (±7days) weeks compared to Baseline within and between arms	1) Baseline, 2) Baseline to 24 weeks (±7days)
Prognostic factor of the Improvement of Fatty liver between baseline and week 24 (±7days) within and between arms	Prediction Factor Analysis of the Improvement of Fatty liver after 24 weeks (±7days) compared to Baseline within and between arms	1) Baseline, 2) Baseline to 24 weeks (±7days)
Prognostic factor of the Improvement of HbA1 between baseline and week 24 (±7days) within and between arms	Prediction Factor Analysis of the Improvement of HbA1c after 24 weeks (±7days) compared to Baseline within and between arms	1) Baseline, 2) Baseline to 24 weeks (±7days)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2020
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): May 1, 2022

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (ACTUAL): October 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Endocrine System Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Fibrosis; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic; Liver Cirrhosis
• Other Study ID Numbers: 4-2019-0305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No