Status:
COMPLETED
Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan
Lead Sponsor:
Takeda
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose ...
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
- A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).
- A HbA1c differences within 10.0%\* (\*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
- Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).
Exclusion
- Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT01263470
Start Date
January 1 2007
End Date
December 1 2007
Last Update
February 3 2012
Active Locations (1)
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1
Okayama, Japan, 701-0192