Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus.

Inclusion Criteria

• Men or women with a historical diagnosis of type 2 diabetes mellitus who were treated with metformin greater than or equal to 1500 mg alone but were experiencing inadequate glycemic control.
• A stable dose of metformin of greater than or equal to 1500 mg or maximum tolerated dose.
• No treatment with antidiabetic agents other than metformin within the 2 months prior to Screening.
• A body mass index greater than or equal to 23 kg/m^2 and less than or equal to 45 kg/m^2.
• Fasting C-peptide greater than or equal to 0.8 ng/mL.
• Regular use of other, non-excluded medications was allowed if a stable dose had been established for at least 4 weeks prior to Screening.
• Systolic blood pressure less than or equal to 160 mmHg and diastolic pressure less than or equal to 100 mmHg.
• Hemoglobin greater than or equal to 12 g/dL for men and greater than or equal to 10 g/dL for women.
• Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal.
• Serum creatinine less than 1.5 mg/dL for men and less than 1.4 mg/dL for women.
• Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject was clinically euthyroid.
• Females of childbearing potential who are sexually active must agree to use adequate 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 prohibited the patient from completing the study.

Exclusion Criteria

• Urine albumin/creatinine ratio greater than 113 mg/mmol at Screening.
• A history of cancer, other than squamous cell or basal cell carcinoma of the skin, that had not been in full remission for at least 5 years prior to Screening.
• A history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
• A history of treated diabetic gastroparesis.
• 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.
• History of infection with hepatitis B, hepatitis C or human immunodeficiency virus.
• History of a psychiatric disorder that could have affected the patient's ability to participate in the study.
• History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
• A history of alcohol or substance abuse within 2 years prior to Screening.
• Receipt of any investigational drug within 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within 3 months prior to Screening.
• Previous participation in an investigational study of alogliptin.
• Hypersensitive to pioglitazone, alogliptin, or other excipients.