Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.

Inclusion Criteria

• Diagnosis of type 2 diabetes
• 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.
• Either failed treatment with diet and exercise for 3 months prior to Screening or has been receiving a stable dose of metformin, sulfonylurea, nateglinide, or repaglinide for more than 3 months prior to Screening.
• Inadequate glycemic control as defined by glycosylated hemoglobin concentration between 6.5 and 9.0%, inclusive.
• Fasting plasma glucose less than 13.3 mmol per L.
• Fasting serum triglyceride level of 1.7 to 5.0 mmol per L, inclusive.
• Has not been receiving any lipid-lowering therapy within 3 months prior to Screening or on a stable statin and/or ezetimibe therapy (same drug and dose) for at least 3 months.
• Body mass index greater than 23 kg/m2 and less than 45 kg/m2.
• If has regular use of other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. Use of as needed prescription medications and over-the-counter medications is allowed at the discretion of the investigator.
• Is to be Apolipoprotein E 3/3 or Apolipoprotein E 3/4 phenotype positive prior to baseline.

Exclusion Criteria

• History of type 1 diabetes.
• History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
• Diastolic blood pressure greater than 100 mm Hg or a systolic blood pressure of greater than 160 mm Hg.
• History of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.
• Hemoglobin less than 120 g per L for males and less than100 g per L for females.
• Alanine transaminase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
• Serum creatinine level greater than 133 μmol per L.
• Fasting total cholesterol greater than 6.5 mmol per L.
• New York Heart Association heart failure of any Class (I-IV) regardless of therapy.
• History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
• History of acute metabolic diabetic complications.
• History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
• History of infection with human immunodeficiency virus.
• History of diabetic gastro paresis.
• History of gastric bypass surgery.