Status:
COMPLETED
Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan
Lead Sponsor:
Takeda
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
33-85 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40 consecutive week...
Detailed Description
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. Takeda is developing SYR-322 (alogliptin) for the improvement of glycem...
Eligibility Criteria
Inclusion
- Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).
Exclusion
- Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
- Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT01263509
Start Date
June 1 2007
End Date
October 1 2008
Last Update
February 3 2012
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