Clinical trial NCT04584242: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.)

Primary outcomes:
measure: Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days)
timeFrame: Baseline
measure: Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days)
timeFrame: Baseline to 24 weeks (±7days)
Secondary outcomes:
measure: Changes from baseline CAP (Controlled Attenuation Parameter) at week 24 (±7days) within and between arms
timeFrame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
measure: Changes from baseline HbA1c at week 24 (±7days) within and between arms
timeFrame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
measure: Changes from baseline Insulin at week 24 (±7days) within and between arms
timeFrame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
measure: Changes from baseline lipid profile (total cholesterol, HDL, LDL, TG) at week 24 (±7days) within and between arms
timeFrame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
measure: Changes from baseline AST/ALT at week 24 (±7days) within and between arms
timeFrame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
measure: Changes from baseline Body weight at week 24 (±7days) within and between arms
timeFrame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
measure: Changes from baseline Liver fibrosis and fatty liver at week 24 (±7days) among the MRE+MRI PDFF enforcement arms within and between arms
timeFrame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
measure: Proportions of adverse effects and drug interruptions or changes between baseline and week 24 (±7days) within and between arms
timeFrame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
measure: Prognostic factor of the Improvement of Liver fibrosis between baseline and week 24 (±7days) within and between arms
timeFrame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
measure: Prognostic factor of the Improvement of Fatty liver between baseline and week 24 (±7days) within and between arms
timeFrame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
measure: Prognostic factor of the Improvement of HbA1 between baseline and week 24 (±7days) within and between arms
timeFrame: 1) Baseline, 2) Baseline to 24 weeks (±7days)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Seung Up Kim
role: PRINCIPAL_INVESTIGATOR
References: