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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily (QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus.

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

Details

• Lead Sponsor: Takeda
• Treatments: Alogliptin; Pioglitazone

Criteria

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.