A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients
To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian
 subjects with type 2 diabetes mellitus.
Inclusion Criteria:

 -  Diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study

 -  Stable diet and exercise program for at least 8 weeks before the study

 -  On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day
 metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to
 safety concern of metformin

 -  BMI of 20.0 to 45.0 kg/m2

 -  A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of
 discontinuation criteria on fasting plasma glucose

 Exclusion Criteria:

 -  Type 1 diabetes mellitus

 -  Proliferative diabetic retinopathy

 -  Receiving insulin within 12 weeks prior to the study

 -  History of clinically significant renal disease(s)

 -  Significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy
 etc.

 -  Urinary tract infection or genital infection

 -  Continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics

 -  History of cerebrovascular attack, unstable angina, myocardial infarction,
 angioplasty, serious cardiac diseases within 12 weeks prior to the study

 -  Severe infection, serious trauma, or perioperative subject

 -  Known or suspected hypersensitivity to ASP1941

 -  History of treatment with ASP1941

 -  Participated in another clinical study, postmarketing study or medical device study
 within 12 weeks before the study

 -  Serum creatinine value exceeding the upper limit of normal range

 -  Urinary microalbumin/urinary creatinine ratio >300 mg/g