NCT04584242Unknown4 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days)
研究概览
简要总结
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.
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
- •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
排除标准
- •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.)
研究组 & 干预措施
Pioglitazone
Experimental
干预措施: gluconon tab 15mg (Drug)
Evogliptin
Experimental
干预措施: suganon tab 5mg (Drug)
结局指标
主要结局
Changes from baseline LSM (Liver Stiffness measurement) at week 24 (±7days)
时间窗: Baseline to 24 weeks (±7days)
Changes in the Liver Stiffness measurement after 24 weeks (±7days) compared to Baseline within and between arms
次要结局
- Changes from baseline HbA1c at week 24 (±7days) within and between arms(1) Baseline, 2) Baseline to 24 weeks (±7days))
- 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))
- Changes from baseline CAP (Controlled Attenuation Parameter) at week 24 (±7days) within and between arms(1) Baseline, 2) Baseline to 24 weeks (±7days))
- Changes from baseline Insulin at week 24 (±7days) within and between arms(1) Baseline, 2) Baseline to 24 weeks (±7days))
- 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))
- 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))
- 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))
- Changes from baseline AST/ALT at week 24 (±7days) within and between arms(1) Baseline, 2) Baseline to 24 weeks (±7days))
- Changes from baseline Body weight at week 24 (±7days) within and between arms(1) Baseline, 2) Baseline to 24 weeks (±7days))
- 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))
- 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))
研究者
研究点 (4)
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