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

Yonsei University

Status and phase

Unknown

Phase 4

Conditions

Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes

Treatments

Drug: gluconon tab 15mg

Drug: suganon tab 5mg

Study type

Interventional

Funder types

Other

Identifiers

NCT04584242

4-2019-0305

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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.)