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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04584242
Recruitment Status : Recruiting
First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes Drug: gluconon tab 15mg Drug: suganon tab 5mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 3, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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) ]
    Change from baseline at Week 24 (±7days) is defined as [(Baseline CAP value) - (Follow-up CAP value)] / (Baseline CAP value) * 100 (%)

  2. Changes from baseline HbA1c at week 24 (±7days) within and between arms [ Time Frame: 1) Baseline, 2) Baseline to 24 weeks (±7days) ]
    Change from baseline at Week 24 (±7days) is defined as HbA1c at Week 24 (±7days) minus HbA1c at Week 0

  3. Changes from baseline Insulin at week 24 (±7days) within and between arms [ Time Frame: 1) Baseline, 2) Baseline to 24 weeks (±7days) ]
    Change from baseline at Week 24 (±7days) is defined as insulin at Week 24 (±7days) minus insulin at Week 0

  4. 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) ]
    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

  5. Changes from baseline AST/ALT at week 24 (±7days) within and between arms [ Time Frame: 1) Baseline, 2) Baseline to 24 weeks (±7days) ]
    Change form baseline at Week 24 (±7days) is defined as the proportion of AST/ALT values who are normalized at Week 24 (±7days)

  6. Changes from baseline Body weight at week 24 (±7days) within and between arms [ Time Frame: 1) Baseline, 2) Baseline to 24 weeks (±7days) ]
    Change from baseline at Week 24 (±7days) is defined as body weight at Week 24 minus body weight at Week 0

  7. 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) ]
    Change from baseline at Week 24 (±7days) is defined by MRE+MRI PDFF

  8. 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) ]
    Compare between baseline at Week 24 (±7days) is defined as the occurrence rate of adverse events and drug interruptions or changes

  9. 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) ]
    Prediction Factor Analysis of the Improvement of Liver fibrosis after 24 (±7days) weeks compared to Baseline within and between arms

  10. 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) ]
    Prediction Factor Analysis of the Improvement of Fatty liver after 24 weeks (±7days) compared to Baseline within and between arms

  11. 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) ]
    Prediction Factor Analysis of the Improvement of HbA1c after 24 weeks (±7days) compared to Baseline within and between arms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584242


Contacts
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Contact: Seung Up Kim +82-2228-1982 ksukorea@yuhs.ac

Locations
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Korea, Republic of
Gangnam Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Jung il Lee    82-10-2218-9331    mdflorence@yuhs.ac   
Samsung Hospital Recruiting
Seoul, Korea, Republic of
Contact: Won seok Kang    82-10-8750-5033    wonseok1202.kang@samsung.com   
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Su jong Yu    82-2-2072-2228    ydoctor2@hanmail.net   
Yonsei Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Seung Up Kim    +82-2228-1982    ksukorea@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Seung Up Kim Severance Hospital
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04584242    
Other Study ID Numbers: 4-2019-0305
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Cirrhosis
Fibrosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Hepadnaviridae Infections
DNA Virus Infections