JPRN-jRCT2051190094已完成3 期
A multicenter, open-label, single-arm, extension study with regard to the safety and efficacy of empagliflozin in patients with refractory diabetes mellitus with insulin resistance - EMPIRE-02
Ogawa Wataru0 个研究点目标入组 8 人开始时间: 2020年1月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
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 ot applicable（—）
- 性别
- All
入选标准
- •(1)It is an extension study of the EMPIRE-01 study
- •(2)Based on the Article 50 of GCP Ordinance
排除标准
- •(1)A patient with a medical history of acute coronary syndrome (including non-ST-elevation myocardial infarction, ST-elevation myocardial infarction and unstable angina pectoris), stroke or transient ischemic attack (TIA) within 3 months before obtaining consent
- •(2)A patient with suspected hepatic dysfunction that either of serum ALT, AST or alkaline phosphatase is exceeding 3-fold of upper limit of normal range prior to starting extension study treatment (Day 0)
- •(3)A patient who is receiving a systemic steroid at the time of consent (except for type B)
- •(4)A patient whose thyroid hormone product dose has been changed within 6 weeks before obtaining consent
- •(5)A patient with unstable endocrine diseases other than diabetes mellitus
- •(6)A patient with hemolysis or blood diseases that destabilize erythrocytic cells and other various disorders (e.g., malaria, babesiosis, hemolytic anemia)
- •(7)A premenopausal female patient (the latest menstruation was within 1 year before obtaining consent), a lactating or pregnant patient, or a patient who may be pregnant (without hysterectomy or ovariectomy) who has no intention to use efficacious contraception defined in this study during the study period and would not agree to receive regular pregnancy tests during the study period
- •(8)A patient who has experienced alcohol abuse or drug abuse within 3 months before obtaining consent, which may disturb the study participation
- •(9)A patient who is in the condition that makes it difficult to administer the study drug
- •(10)A patient with renal dysfunction of eGFR (MDRD calculating formula) <45 mL/min/1.73 m2 prior to starting extension study treatment (Day 0)
- •(11)A patient who indicates a hypersensitivity response to empagliflozin or its excipients, or a patient with lactose-intolerance
- •(12)A patient with severe ketosis, diabetic coma or precoma, severe infection, perioperative status, or serious trauma
- •(13)A patient that the investigator and/or subinvestigator, etc., has judged to be ineligible to this study for other reasons
研究者
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