CL Item
Subject has signed informed consent prior to screening (1)
CL Item
Subject is male or female of 18 years of age at Visit 1 (2)
CL Item
Subject has been diagnosed with T2DM for at least 6 month (3)
CL Item
Subject has indequate glycemic control indicated by an HbA1clevel between 7.0% and 9.5% at start of the placebo run-in period at Visit 1 AND does not meet any of the FPG discontinuation criteria (see section 3.4) (4)
CL Item
Subject has been on a stable dose of at least 1500 mg/day metformin monotherapy for at least 6 weeks prior to Visit 1. (5)
CL Item
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. (6)
CL Item
Subject has a body mass index (BMI) 20-45 kg/m2 at Visit 1 (7)
CL Item
Female subject of childbearing potential has a negativ 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. Acceptable methods of contraception are: oral or injectable hormonal contraceptives, contraceptive patch, intra-uterine devices, vaginal hormonal rings, or sterilization by surgery and only in combination with a male condom, a vaginal diaphragm or cervical caps. 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 month after the last dose. (8)