A Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

Inclusion Criteria:

• Subject has been diagnosed with type 2 diabetes mellitus.
• Subject has an HbA1c value between 7.0% and 10.5 % at visit 1.
• Subject shows FPG (Fasting Plasma Glucose) value is less than 270mg/dL.
• Subject shows a BMI of 20.0 to 45.0 kg/m2.
• Subject is on stable diet and exercise program at least 8 weeks prior to study participation.
• Postmenopausal female or surgically sterile female or agree not to become pregnant.

Exclusion Criteria:

• Subject has type 1 diabetes mellitus.
• Subject has proliferative diabetic retinopathy.
• Subject has a history of clinically significant renal disease(s) such as renovascular occlusive disease, nephrectomy, or renal transplant.
• Subject has significant dysuria caused by a neurogenic bladder or a benign prostatic hypertrophy etc.
• Subject has a symptomatic urinary tract infection or genital infection.
• Subject has chronic disease(s) that require the continuous use of systemic corticosteroids or immunosuppressants.
• Subject has cardiovascular disease or cerebrovascular disease that may affect the administration of ASP1941 or its safety assessment in the opinion of the investigator or sub-investigator.
• Subject has uncontrollable psychiatric disorder(s) with medication.
• Male subject is not willing to use appropriate contraception during the study.
• Subject has severe infection, serious trauma, or perioperative subject.
• Subject has a malignant tumor or has a history of malignant tumor.
• Subject has severe gastrointestinal disease, or history of operation for serious gastrointestinal disease.
• Subject has diabetic ketoacidosis.
• Subject has lactic acidosis or has history of lactic acidosis.
• Subject has hepatitis or is a carrier of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or is positive for HIV-1 and/or HIV-2.
• Subject has a history of thyroid dysfunction and acute pancreatitis.
• Subject is on weight-loss program or weight-loss medication (e.g. orlistat, phentermine/topiramate, lorcaserin) within 12 weeks of study participation.
• Subject has a history of serious cardiac diseases (NYHA Class III to IV), congestive heart failure, arrhythmia in need of medical treatment.
• Subject has a history of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, within 52 weeks (364 days) of study participation.
• Subject has uncontrollable severe hypertension, i.e., systolic blood pressure of higher than 180 mmHg or diastolic blood pressure of higher than 110mmHg measured in a sitting position after a 5-minute rest.

• Subject has following AST or ALT value:

  • AST: Male > 100 U/L, Female > 80 U/L
  • ALT: Male > 102.5 U/L, Female > 82.5 U/L

• Subject has following serum creatinine value:

  • Creatinine: Male > 1.3 mg/dL, Female > 1.2 mg/dL
• Subject has estimated GFR values, of < 60 mL/min/1.73m2.