Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus

Completed · Phase 3

Conditions studied: Diabetes Mellitus

In brief

The purpose of this study is to evaluate the long-term safety of alogliptin, once daily (QD), following participation in 1 of 7 controlled studies in patients with type 2 diabetes mellitus.

Key facts

Study ID

NCT00306384

Run by

Takeda

People needed

3323

Starts

2006-03-01

Expected to finish

2011-11-01

Last updated by the study team

2013-03-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Type 2 diabetes mellitus and was enrolled in one of the following 7 controlled Phase III studies. The study will be open to all patients who completed one of these studies through the end-of-treatment visit:
• SYR-322-PLC-010 - NCT00286455
• SYR-322-SULF-007 - NCT00286468
• SYR-322-MET-008 - NCT00286442
• SYR-322-TZD-009 - NCT00286494
• SYR-322-INS-011 - NCT00286429
• 01-05-TL-322OPI-001 - NCT00328627
• 01-06-TL-322OPI-002 - NCT00395512
• Alanine aminotransferase less than or equal to 3 times the upper limit of normal and serum creatinine less than or equal to 2.0 mg per dL.
• Able and willing to monitor own blood glucose concentrations with a home glucose monitor.
• No major illness or debility that in the investigator's opinion prohibits the patient from completing the study.

You may not qualify if…

• The occurrence of any adverse event or condition during the controlled Phase III studies, which, in the opinion of the investigator, should exclude the patient from participating in the open-label extension.
• Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
• Weight-loss drugs
• Investigational antidiabetics, additional dipeptidyl peptidase-4 (DPP-4) and glucagon-like peptide-1 (GLP 1) inhibitors
• Incretin Mimetics,
• Oral or systemically injected glucocorticoids.

Where it is running

• Study site — Peoria, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Artesia, California, United States
• Study site — Fresno, California, United States
• Study site — Los Angeles, California, United States
• Study site — Mission Viejo, California, United States
• Study site — Northridge, California, United States
• Study site — Orange, California, United States
• Study site — San Diego, California, United States
• Study site — Tustin, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Clearwater, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Longwood, Florida, United States
• Study site — New Port Richie, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Ocoee, Florida, United States
• Study site — Saint Cloud, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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