Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus

Inclusion Criteria

• •Diagnosis of type 2 diabetes mellitus currently treated with a thiazolidinedione either alone or in combination with metformin or a sulfonylurea but who are experiencing inadequate glycemic control. The subject should have received the thiazolidinedione therapy (rosiglitazone or pioglitazone) either alone or in combination with metformin or a sulfonylurea for at least the 3 months prior to Screening and must have been on a stable dose for all their antidiabetic treatments for at least the month prior to Screening.
• •No treatment with antidiabetic agents other than a thiazolidinedione alone or in combination with either metformin or a sulfonylurea within the 3 months prior to Screening. (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)
• •Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2
• •Fasting C-peptide concentration greater than or equal to 0.8 ng per mL. (If this screening criterion is not met, the subject still qualifies if C-peptide is greater than or equal to 1.5 ng per mL after a challenge test.)
• •Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive.
• •If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
• •Systolic blood pressure less than or equal to 180 mm Hg and diastolic pressure less than or equal to 110 mm Hg.
• •Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to10 g per dL for females.
• •Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal.
• •Serum creatinine less than or equal to 2.0 mg per dL.
• •Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid.
• •Neither pregnant nor lactating.
• •Female subjects of childbearing potential must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in 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 subject from completing the study.
• •Able and willing to provide written informed consent.