Status:
COMPLETED
Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Takeda
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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.
Detailed Description
SYR-322 (alogliptin) is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in respons...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
3323 Patients enrolled
Trial Details
Trial ID
NCT00306384
Start Date
March 1 2006
End Date
November 1 2011
Last Update
March 22 2013
Active Locations (114)
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1
Birmingham, Alabama, United States
2
Peoria, Arizona, United States
3
Phoenix, Arizona, United States
4
Anaheim, California, United States