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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Alogliptin; Pioglitazone

Criteria

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.