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
NCT ID: NCT04584242
Last Updated: 2020-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2020-09-03
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pioglitazone
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
Evogliptin
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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 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.)
20 Years
80 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Seung Up Kim
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Gangnam Severance Hospital
Seoul, , South Korea
Samsung Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2019-0305
Identifier Type: -
Identifier Source: org_study_id
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