Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes
Conditions
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.
Interventions
DRUGgluconon 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
DRUGsuganon 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
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days) | Baseline | Changes in the Liver Stiffness measurement after 24 weeks (±7days) compared to Baseline within and between arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline HbA1c at week 24 (±7days) within and between arms | 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 |
| Changes from baseline Insulin at week 24 (±7days) within and between arms | 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 |
| Changes from baseline lipid profile (total cholesterol, HDL, LDL, TG) at week 24 (±7days) within and between arms | 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 |
| Changes from baseline AST/ALT at week 24 (±7days) within and between arms | 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) |
| Changes from baseline Body weight at week 24 (±7days) within and between arms | 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 |
| Changes from baseline CAP (Controlled Attenuation Parameter) at week 24 (±7days) within and between arms | 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 (%) |
| Proportions of adverse effects and drug interruptions or changes between baseline and week 24 (±7days) within and between arms | 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 |
| Prognostic factor of the Improvement of Liver fibrosis between baseline and week 24 (±7days) within and between arms | 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 |
| Prognostic factor of the Improvement of Fatty liver between baseline and week 24 (±7days) within and between arms | 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 |
| Prognostic factor of the Improvement of HbA1 between baseline and week 24 (±7days) within and between arms | 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 |
| Changes from baseline Liver fibrosis and fatty liver at week 24 (±7days) among the MRE+MRI PDFF enforcement arms within and between arms | 1) Baseline, 2) Baseline to 24 weeks (±7days) | Change from baseline at Week 24 (±7days) is defined by MRE+MRI PDFF |
Countries
South Korea
Contacts
Primary ContactSeung Up Kim
Outcome results
None listed