Tofogliflozin GLP-1 Analogue Combination Trial
Tofogliflozin GLP-1 Analogue Combination Trial
An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and
 efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus.
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