A Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance

Exclusion Criteria

• •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 in the screening period is exceeding 3-fold of upper limit of normal rang
• •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 treatment period and would not agree to receive regular pregnancy tests during the treatment 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 in the screening period
• •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