JPRN-jRCTs061210009招募中未知
Additional effect of luseogliflozin on semaglutide for non-alcoholic steatohepatitis patients with type 2 diabetes - Alight Study
Hiasa Yoichi0 个研究点目标入组 60 人开始时间: 2021年6月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •NASH with type 2 diabetes
- •1. Patients aged 20 to 75 years at the time of consent
- •2. Patients with type 2 diabetes who were diagnosed with NASH with stage 1 or more and NAS 4 or more according to the classification of the NASH Clinical Research Network (NASH CRN) by liver biopsy within 6 months (180 days) before pre-examination or consent acquisition
- •3. Patients with HbA1c 6.5% or more (HbA1c 6% or more for those undergoing drug treatment) and 10.5% or less in the preliminary examination
- •4. Patients who provided written consent to participate in this study
排除标准
- •1. Patients who received SGLT2 inhibitors or GLP-1 receptor agonists within 3 months (90 days) prior to the start of the drug administration study or after liver biopsy
- •2. Patients who used other SGLT2 inhibitors or GLP-1 receptor agonists during the study period
- •3. Patients with a history of serious adverse reactions to SGLT2 inhibitors or GLP-1 receptor agonists in the past
- •4. Patients with uncompensated liver cirrhosis (Child-Pugh B or C)
- •5. Patients with serious renal disease (serum Cr > 2.0 mg/dL or CKD stage 4 or higher)
- •6. Patients with malignant tumor
- •7. Patients with a history of severe hypoglycemia
- •8. Patients with a history of ketoacidosis
- •9. Patients with a history of cerebral infarction with paralysis
- •10. Patients with urinary tract/genital infections or repeated urinary tract/genital infections
- •11. Patients with the following complications: hepatitis due to other causes such as viral hepatitis, autoimmune hepatitis, primary cholestatic cholangitis, psychiatric disorders, seizures, and paroxysmal diseases
- •12. Patients who were hospitalized for acute coronary syndrome, unstable angina, acute myocardial infarction, acute cerebral infarction, or transient ischemic attack within 3 months (90 days) prior to obtaining consent
- •13. Pregnant or lactating women, women who may become pregnant, or women who wish to become pregnant
- •14. Patients who had started or changed the dose of pioglitazone or vitamin E within 6 months (180 days) prior to starting the study drug, or within 3 months (90 days) prior to liver biopsy until starting the study drug
- •15. Patients who regularly use oral steroids or injectable steroids
- •16. Patients who are participating or intend to participate in other clinical studies using the study drug while participating in this study
- •17. If, in the opinion of the Principal Investigator, or others, participation in the research is not in the best interest of the research subject (e.g., to the detriment of the welfare of the research subject), or if it is judged to interfere with, limit, or confuse the specific evaluation of the clinical research protocol
- •18. A person under the direction of the Principal Investigator or the medical institution conducting the research, an employee of the Principal Investigator or of the medical institution directly involved in this or other clinical research, or family members of such employees or the Principal Investigator
研究者
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