Tofogliflozin GLP-1 Analogue Combination Trial

Inclusion criteria

• The subject aged from 20 to 75 years old with type 2 diabetes mellitus(T2DM)
• The subject with hemoglobin A1c ≧7.5% - <10.5 %
• The subject who has been receiving a stable dose and regimen of GLP-1 analogue over 8 weeks before Screening test

Exclusion criteria

• The subject with type 1 diabetes mellitus
• The subject with Pregnancy or lactation
• The subject with Fasting Plasma Glucose ≧ 270 mg/dl
• The subject with history of metabolic acidosis, including diabetic ketoacidosis ,within 1 year prior to screening
• The subject with myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months
• The subject with serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women
• The subject with aspartate aminotransferase(AST) or alanine aminotransferase(ALT) ≧ 2.5 times the upper limit of the reference range at the central laboratory test facility
• The subject has received treatment with another investigational product or non-approved drug 3 months before screening
• The subject with history of Tofogliflozin therapy
• The subject with estimated glomerular filtration rate of <30 mL/min/1.73 m^2
• The subject who frequently experiencing orthostatic hypotension
• The subject systolic blood pressure of ≧ 180 or mmHg of diastolic blood pressure of ≧ 100 mmHg
• The subject required a change in the dosing regiment for the following drugs within 4 weeks before screening : Lipid-lowering drug , Antihypertensive drug, Thyroid hormone drug , Uric acid lowering drug