Clinical trial NCT01117584 (phase 2, status: completed)
Conditions: type 2 diabetes mellitus
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: ipragliflozin, placebo, metformin
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, CSCC[C@H](N)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Subject has been diagnosed with Diabetes Mellitus type 2 (T2DM) for at least 6 months

          -  Subject has inadequate glycemic control indicated by an HbA1c level between 7.0% and
             9.5% at start of the run-in period at Visit 1 AND does not meet any of the FPG
             discontinuation criteria

          -  Subject has been on a stable dose of at least 1500 mg/day metformin monotherapy for at
             least 6 weeks prior to Visit 1

          -  Subject is on a stable diet and exercise program (for at least 6 weeks prior to Visit
             1) and is willing to remain on this program for the duration of the study

          -  Subject has a body mass index (BMI) 20 - 45 kg/m2 at Visit 1

          -  Female subject of childbearing potential has a negative serum pregnancy test (human
             chorionic gonadotropin [hCG]) at Visit 1 and agrees to use an acceptable form of
             contraception throughout the duration of the study OR is at least 1 year
             post-menopausal (defined as amenorrhea for at least 1 year) or surgically sterile.
             Male study subjects should be advised to use a male condom in addition to having their
             partner use another acceptable method during the study and for 3 months after the last
             dose

        Exclusion Criteria:

          -  Subject has any known complication of T2DM indicating a late disease state that in the
             investigator's opinion should preclude the subject from participation

          -  Subject has type 1 diabetes mellitus

          -  Subject is in need of insulin therapy or has received insulin within 3 months prior to
             Visit 1, with the exception of acute use of <7 days

          -  Subject has a serum creatinine higher than upper limit of normal range at Visit 1

          -  Subject has an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
             higher than 3 times upper limit of normal range or has a total bilirubin more than 2
             times upper limit of normal at Visit 1

          -  Subject has a urinary microalbumin/creatinine ratio above or equal to 300 mg/g at
             Visit 1

          -  Subject has a symptomatic urinary tract infection (UTI) or symptomatic genital
             infection at Visit 1 or during the placebo run-in period, including just prior to
             randomization at Visit 2

          -  Subject has persistent, uncontrolled severe hypertension as indicated by a systolic
             blood pressure >180 mmHg or a diastolic blood pressure of >110 mmHg taken in a sitting
             position after 5 minutes of rest on at least 2 measurements (within 30 minutes of each
             other) at Visit 1

          -  Subject has a significant cardiovascular disease, such as myocardial infarction or a
             vascular intervention (e.g. angioplasty or stent) within 3 months prior to Visit 1, or
             history of heart failure (New York Heart Association [NYHA] Class III IV)

          -  Subject is known to have hepatitis or be a carrier of hepatitis B surface antigen
             (HBsAg), hepatitis C virus (HCV) antibody (enzyme linked immunosorbent assay [ELISA]
             plus confirmatory test), or is known positive for human immunodeficiency virus (HIV)
             HIV-1 and/or HIV 2

          -  Subject is currently receiving an excluded medication (loop-diuretics or systemic
             corticosteroids) or has received any other oral anti-diabetic drug except for
             metformin within 3 months prior to Visit 1

          -  Subject has history of lactic acidosis

          -  Subject has a history of drug or alcohol abuse/dependency within 12 months prior to
             Visit 1 as defined in the Diagnostic and Statistical Manual-IV (DSM-IV)

          -  Subject has had a malignancy in the last 5 years, except for adequately treated basal
             or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

          -  Female subject who is pregnant, lactating or pre-menopausal with positive serum
             pregnancy test (hCG) at Visit 1 or has an intention of becoming pregnant

          -  Subject has an unstable medical or psychiatric illness

          -  Subject has known or suspected hypersensitivity to ASP1941 or any components of the
             formulations used

          -  Subject has previously received ASP1941

          -  Subject is concurrently participating in another drug study or has received an
             investigational drug within 30 days (or the limit set by national law, whichever is
             longer) prior to Visit 1

          -  Subject has any concurrent illness which, in the opinion of the investigator, may
             interfere with treatment or evaluation of safety or completion of this study

          -  In the investigator's judgment, the subject is unable to adhere to the treatment
             regimen, protocol procedures or study requirements