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
- Conditions
- Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes
- Interventions
- Drug: suganon tab 5mgDrug: gluconon tab 15mg
- Registration Number
- NCT04584242
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
-
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
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Evogliptin suganon tab 5mg - Pioglitazone gluconon tab 15mg -
- Primary Outcome Measures
Name Time Method Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days) 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
Name Time Method 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 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 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 (%)
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 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
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 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 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
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 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
Trial Locations
- Locations (4)
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei Severance Hospital
🇰🇷Seoul, Korea, Republic of