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

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University

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.)