Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.

Exclusion Criteria

• •Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the subject may be rescreened within 1 week.
• •History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.)
• •History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
• •History of treated diabetic gastric paresis.
• •New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study.
• •History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
• •History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
• •History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
• •History of a psychiatric disorder that will affect the subject's ability to participate in the study.
• •History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
• •History of alcohol or substance abuse within the 2 years prior to Screening.
• •Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening.
• •Prior treatment in an investigational study of alogliptin.
• •Excluded Medications and Treatments:
• •* Treatment with antidiabetic agents other than study drug or glyburide is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures.
• •* Treatment with weight-loss drugs, any investigational antidiabetics, Bosentan (used for the treatment of pulmonary hypertension), or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of- treatment/early termination procedures. Inhaled corticosteroids are allowed.
• •* Subjects must not take any medications, including over-the-counter products, without first consulting with the investigator.