Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes

• Status: Active, not recruiting
• Trial end date: 2023-02-19
• Target enrollment: 0
• Participant gender: All

Summary

An exploratory comparison of changes in liver fibrosis through glycemic control within and between groups after administration of Pioglitazone and Evogliptin in chronic hepatitis B patients with type 2 diabetes and liver fibrosis

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

Details

• Lead Sponsor: Seung Up Kim
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• Adult aged 20 or over and under 80 years of age

• Those who satisfy the following conditions among chronic hepatitis B patients diagnosed with type 2 diabetes.

first. For the first diagnosis of type 2 diabetes: 6.5% ≤ HbA1c < 10.0%; second. Diagnosed with type 2 diabetes: HbA1c < 10.0%;

• Subjects who show significant liver fibrosis of 7 kilopascal or more in liver elasticity test using Fibroscan.

• Subjects who voluntarily sign the informed consent form after understanding the clinical study and being informed of the risks and benefits.

Exclusion Criteria:

• Those who are currently taking Pioglitazone or Evogliptin, or those who have stopped taking medication for less than 4 weeks.

• Patients meeting the criteria for alcoholic fatty liver (if alcohol intake exceeds 210 g per week for men and 140 g per week for women for the past 2 years)

• Cirrhosis patients with decreased liver function (CTP class B and C)

• Those taking drugs that can cause fatty liver (amiodarone, methotrexate, tamoxifen, valproate, corticosteroids, etc.)

• Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis (within 24 weeks)

• In case of allergy or hypersensitivity reaction to the target drug or its components.

• Patients treated with oral or parenteral corticosteroids chronically (>14 consecutive days) within 8 weeks prior to screening

• Malnutrition, starvation, and debilitating conditions (including patients with severe infections and severe trauma before and after surgery)

• Patients receiving or receiving radiation and chemotherapy for malignancy for less than 2 years.

• Heart failure (class III-IV in New York Heart Association classification) or uncontrolled arrhythmias within 24 weeks

table. New York Heart Association Classification. Class I: Normal athletic ability; Class Ⅱ: Difficulty breathing, palpitations, chest pain, etc. appear due to daily exercise (fast walking or climbing a hill); Class Ⅲ: Symptoms appear with light exercise (walking on flat ground); Class IV: Symptoms appear even at rest;

• Patients with acute cardiovascular disease within 12 weeks (patients with a history of unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or coronary intervention)

• Patients with renal failure, chronic renal disease (estimated glomerular filtration rate <60 mL/min/1.73 m2) or patients on dialysis.

• Anemic patients with an Hb level of less than 10.5 g/dl.

• Pregnant or lactating women

• Patients who do not consent to the use of appropriate contraceptive methods during the clinical trial period only for women or men of childbearing potential.

• Patients who have taken clinical trial drugs from other clinical trials within 4 weeks of consenting to the document.

• Persons unable to participate in clinical trials due to the judgment of other researchers.

• Persons who cannot read consent forms (eg illiterate, foreigners, etc.)