Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics

Inclusion Criteria

• Has a diagnosis of type 2 diabetes mellitus with either:
• Failed diet and exercise therapy alone as demonstrated by inadequate glycemic control while receiving no antidiabetic treatment within the two months prior to Screening, or
• Failed treatment with oral monotherapy alone (may include treatment with two or more antidiabetic agents if for less than 7 days) as demonstrated by inadequate glycemic control within the two months prior to Screening.
• Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.
• If regularly using other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening.
• Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
• Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
• No major illness or debility that in the investigator's opinion prohibits the participant from completing the study.

Exclusion Criteria

• Systolic blood pressure greater than or equal to 160 mm Hg and/or diastolic pressure greater than or equal to 100 mm Hg.
• Hemoglobin less than or equal to 12 g/dL for males or less than or equal to 10 g/dL for females.
• Alanine aminotransferase greater than or equal to 3 times the upper limit of normal.
• Calculated creatinine clearance less than or equal to 50 mL/min.
• Thyroid-stimulating hormone level outside of the normal range.
• 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.
• History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
• History of treated diabetic gastroparesis, gastric banding, or gastric bypass surgery.
• New York Heart Association Class III or IV heart failure regardless of therapy.
• 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 Human Immunodeficiency Virus.
• History of a psychiatric disorder that will affect the participant'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.
• History of treatment with any weight-loss drugs or oral or systemically injected glucocorticoids within the 3 months prior to Screening.
• Receipt of any investigational drug within the 30 days prior to Screening.
• Prior treatment in an investigational study of alogliptin.
• Clinically significant medical abnormality or disease or clinically significant abnormal findings at Screening (other than type 2 diabetes) that, in the opinion of the investigator, should exclude the participant from the study.
• Has donated more than 400 mL of blood within the 90 days preceding their participation in the study.
• Has hypersensitivity or has had an anaphylactic reaction(s) to any DPP-4 inhibitor drug.