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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Takeda
• Treatments: Alogliptin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria

• 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.