Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 DiabetesPhase 4NCT04584242

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

A Phase 4 study testing gluconon tab 15mg and suganon tab 5mg in people with Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes, run by Yonsei University at 4 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes
What is being tested?: gluconon tab 15mg and suganon tab 5mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 4 sitesSouth Korea
Study dates: 3 Sep 2020to May 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adultes between 20 and 80 years of age
Patients who satisfy the following conditions among chronic hepatitis B patients diagnosed with type 2 diabetes
Patients who are newly diagnosed as type 2 diabetes : 6.5% ≤ HbA1c < 10.0%
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

Who cannot join

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;

Show all 18Show fewer

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.)

Trial locations and contacts

4 sites in 1 country.

Seung Up Kim contact

+82-2228-1982

ksukorea@yuhs.ac

South Korea4 sites, 4 recruiting

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

Other trials in South Korea

About this study

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

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.

Conditions: Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes
Being tested: gluconon tab 15mg, suganon tab 5mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

gluconon tab 15mgDrug
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
suganon tab 5mgDrug
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

Study groups in NCT04584242
Study group	Role	What they receive
Pioglitazone	Experimental	Not described Receives: Drug: gluconon tab 15mg
Evogliptin	Experimental	Not described Receives: Drug: suganon tab 5mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: Baseline to 24 weeks (±7days)

Secondary outcomes (11)

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 (%)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1) Baseline, 2) Baseline to 24 weeks (±7days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 2020May 2022

First posted12 Oct 2020
Study start3 Sep 2020
Primary completionMay 2022 (estimated)
Study completionMay 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Yonsei UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04584242
Sponsor's protocol ID: 4-2019-0305
Status last verified: Oct 2020
First submitted: 24 Sep 2020
Last updated: 12 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04584242
Acronym / sponsor ID: 4-2019-0305
Conditions: Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Yonsei UniversityUniversity, hospital or other
Study start: 3 Sep 2020 (actual)
Primary completion: May 2022 (estimated)
Study completion: May 2022 (estimated)
First posted: 12 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pioglitazone	Experimental	Drug: gluconon tab 15mg
Evogliptin	Experimental	Drug: suganon tab 5mg

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adultes between 20 and 80 years of age
Patients who satisfy the following conditions among chronic hepatitis B patients diagnosed with type 2 diabetes
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

Key exclusion criteria (18 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
gluconon tab 15mgfrosting 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	Drug	Pioglitazone
suganon tab 5mgfrosting 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	Drug	Evogliptin

Primary outcome

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

11 secondary outcomes

Changes from baseline CAP (Controlled Attenuation Parameter) at week 24 (±7days) within and between arms
Time frame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
Changes from baseline HbA1c at week 24 (±7days) within and between arms
Time frame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
Changes from baseline Insulin at week 24 (±7days) within and between arms
Time frame: 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
Time frame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
Changes from baseline AST/ALT at week 24 (±7days) within and between arms
Time frame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
Changes from baseline Body weight at week 24 (±7days) within and between arms
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1) Baseline, 2) Baseline to 24 weeks (±7days)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Seung Up Kim contact

+82-2228-1982

ksukorea@yuhs.ac

Seung Up Kim principal investigator

Severance Hospital

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Seung Up Kim (+82-2228-1982, ksukorea@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04584242.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.