Clinical trial NCT02452632 (phase 3, status: completed)
Conditions: type 2 diabetes mellitus
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: asp1941, placebo
SMILES: OC[C@H]1O[C@H]([C@H](O)[C@@H](O)[C@@H]1O)C1=CC=C(F)C(CC2=CC3=CC=CC=C3S2)=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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.