A Study to Assess the Efficacy and Safety of ASP1941 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 6 weeks before the study
• for the hypoglycemic agent non-naïve subject, subject has been receiving a single hypoglycemic agent or low-dose of a dual combination therapy
• BMI of 20.0 to 45.0 kg/m2
• for the hypoglycemic agent non-naïve subject, subject has a HbA1c value between 6.8 and 10.0% at screening AND has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period
• for the hypoglycemic agent naïve subject, subject has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period

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, acarbose or other alpha-GI
• 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