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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

Primary Purpose

Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

gluconon tab 15mg

suganon tab 5mg

About this trial

This is an interventional treatment trial for Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

Gangnam Severance Hospital
Samsung HospitalRecruiting
Seoul National University Hospital
Yonsei Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Pioglitazone

Evogliptin

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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 (%)

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

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

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

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)

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

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

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

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

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

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

Full Information

NCT ID

NCT04584242

First Posted

September 24, 2020

Last Updated

October 7, 2020

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT04584242

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 3, 2020 (Actual)

Primary Completion Date

May 2022 (Anticipated)

Study Completion Date

May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pioglitazone

Arm Type

Experimental

Arm Title

Evogliptin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

gluconon tab 15mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

suganon tab 5mg

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days)

Description

Changes in the Liver Stiffness measurement after 24 weeks (±7days) compared to Baseline within and between arms

Time Frame

Baseline

Title

Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days)

Description

Changes in the Liver Stiffness measurement after 24 weeks (±7days) compared to Baseline within and between arms

Time Frame

Baseline to 24 weeks (±7days)

Secondary Outcome Measure Information:

Title

Changes from baseline CAP (Controlled Attenuation Parameter) at week 24 (±7days) within and between arms

Description

Change from baseline at Week 24 (±7days) is defined as [(Baseline CAP value) - (Follow-up CAP value)] / (Baseline CAP value) * 100 (%)

Time Frame