Prospective, Multicenter, Randomized, and Comparative 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
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Changes in Liver Stiffness Measurement at 24 weeks compared to baseline.
研究概览
简要总结
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
详细描述
Subjects who satisfy the selection/exclusion criteria and agree to participate in the clinical trial are randomly assigned to receive clinical trial drugs in a 1:1 ratio based on Visit 2 (Baseline) and take it for 24 weeks.
After that, visits are made at 12 and 24 weeks, and necessary tests are performed to confirm the improvement of liver fibrosis and to evaluate safety.
[Number of subjects and basis for calculation] The target number of test subjects is 40 in total, with 20 in each group (including 10% dropout rate).
The study design is an interventional study design comparing two test drugs, and it is intended to be performed as an exploratory study on safety and efficacy to confirm the possibility of entering a therapeutic confirmation trial.
The number of subjects was assumed by referring to the study on the measurement of liver fibrosis in NAFLD patients with type 2 diabetes in Reference which was conducted as hepatitis B patients with type 2 diabetes, the target disease of this clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.)
研究组 & 干预措施
Pioglitazone 15mg
pioglitazone hydrochloride. PO. 2 tablets once a day.
干预措施: Pioglitazone 15 Mg Oral Tablet (Drug)
Evogliptin 5mg
Evogliptin tartrate. PO. 1 tablets once a day.
干预措施: Evogliptin 5mg (Drug)
结局指标
主要结局
Changes in Liver Stiffness Measurement at 24 weeks compared to baseline.
时间窗: 24 weeks
It is measured based on the CAP score(db/m) and kilopascal from the liver fibroscan and evaluated by performing the paired-sample t-test or Wilcoxon signed test.
次要结局
- Changes in Controlled Attenuation Parameter(CAP) value at 24 weeks compared to baseline.(24 weeks)
- Changes in HbA1c at 24 weeks compared to baseline.(24 weeks)
- Analysis of predictors of HbA1c improvement after 24 weeks compared to baseline.(24 weeks)
- Changes in aspartate aminotransferase(AST)/alanine aminotransferase(ALT) at 24 weeks compared to baseline.(24 weeks)
- Changes in Body weight at 24 weeks compared to baseline.(24 weeks)
- Changes in Insulin at 24 weeks compared to baseline.(24 weeks)
- Changes in lipid profile at 24 weeks compared to baseline.(24 weeks)
- Rate of side effects and discontinuation or change of drug after 24 weeks compared to baseline(24 weeks)
- Analysis of predictors of improvement in liver fibrosis after 24 weeks compared to baseline.(24 weeks)
- Analysis of predictors of improvement of fatty liver after 24 weeks compared to baseline.(24 weeks)
研究者
Seung Up Kim
professor
Yonsei University