Efficacy of Alogliptin With Pioglitazone (Actos®) in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the combination of alogliptin, once daily (QD), and pioglitazone in patients with type 2 diabetes mellitus who are inadequately controlled with diet and exercise alone.

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

Details

• Lead Sponsor: Takeda
• Treatments: Alogliptin; Pioglitazone

Criteria

Inclusion Criteria

• Historical diagnosis of type 2 diabetes.

• Failed treatment with diet and exercise for at least 2 months prior to Screening.

• Is experiencing inadequate glycemic control as defined as glycosylated hemoglobin concentration between 7.5-11%, inclusive.

• Has received any antidiabetic therapy for less than 7 days within 3 months prior to Screening.

• Has a body mass index greater than or equal to 23 kg/m2 and less than or equal to45 kg/m2.

• Fasting C-peptide greater than or equal to 0.8 ng per mL.

• Regular use of other, non-excluded medications is allowed if participant is on a stable dose for at least 4 weeks prior to Screening.

• 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.

• Must be willing and able to monitor their blood concentrations with a home glucose monitor.

Exclusion Criteria

• Systolic blood pressure greater than or equal to 160 mmHg and diastolic blood pressure greater than or equal to 100 mmHg.

• Hemoglobin less than or equal to 12 g per dL for males and less than or equal to 10 g per dL for females.

• Alanine aminotransferase greater than or equal to 2.5times the upper limit of normal.

• Serum creatinine greater than 2.0 mg per dL.

• Thyroid stimulating hormone level greater than the upper limit of normal range.

• Major illness or debility that in the investigator's opinion prohibits the subject from completing the study.

• Urine albumin to creatinine ratio of greater than 1000 ug per mg at Screening. If elevated, the subject may be rescreened within 1 week.

• 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 6 months prior to Screening.

• History of gastroparesis.

• Has New York Heart Association Class I to IV heart failure regardless of therapy.

• History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.

• History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.

• History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.

• History of a psychiatric disorder that will affect 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.

• Any alteration in angiotensin-II receptor inhibitors within 2 months prior to Randomization, if applicable.

• History of alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day) or substance abuse (defined as illicit drug use) within 2 years prior to Screening.

• Received 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.

• Previously participated in an investigational study of SYR-322.

• Glycosylated hemoglobin concentration between 7.5-11%, inclusive, and a fasting plasma glucose less than 310 mg per dL.

• At least 75% compliant with the single-blind placebo regimen during the run-in/stabilization period.