Correlation Between Change of HbA1c, Urinary Glucose Excretion and Other Factors in Patients Treated With Ipragliflozin

Inclusion Criteria:

• Subject who has written informed consent
• Subjects who are diagnosed as type 2 diabetes mellitus
• Subjects who are 20 to 70 years old
• Subjects on a stable diet and exercise at least 8 weeks prior to the study participation
• Stable doses of the following medications for 8 weeks or more but, HbA1c level of 7.0 to 9.5% (Metformin, Metformin + SU, Metformin + DPP-4 inhibitor, Metformin + TZD, TZD, TZD + SU, TZD + DPP-4 inhibitor, SU, SU + DPP-4 inhibitor, DPP-4 inhibitor)

Exclusion Criteria:

• Type 1 DM
• Gestational DM
• Diabetic ketoacidosis
• CKD stage 3B-5 (eGFR 45)
• Severe infection, serious trauma, or perioperative period
• Known or suspected hypersensitivity to ipragliflozin
• Symptomatic urogenital infection
• Chemotherapy or radiation therapy for malignant tumor or diagnosis of malignant tumor within 5 years (except for thyroid cancer)
• Under the therapeutic intervention and/or another clinical study using IP drug
• Hepatic disease ( 3 times of upper normal limit of AST or ALT)
• Serious voiding difficulty due to neurogenic bladder or prostate hyperplasia

• Drugs not allowed for concomitant use

  • Alpha glucosidase inhibitor or meglitinide within 60 days prior to screening
  • Insulin within 60 days prior to screening
  • Systemic steroid use (PO, IV or IM) over 2 weeks within 3 months prior to screening
  • Inhalation or pleural intracavitary injection of steroid known as having high systemic absorption rate
• GLP-1 agonist (except for exenatide) within 60 days prior to screening
• Heart failure (NYHA class III-IV) or uncontrolled arrhythmia within 6 months prior to screening
• Cardiovascular diseases (unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or percutaneous coronary intervention) within 3 months prior to screening
• Subjects who are not eligible to the study according to an investigator's decision
• Inability to read the consent form
• Pregnancy, lactation, or plan to get pregnant during the study period