To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
171
Unnamed facility
Busan, South Korea
Unnamed facility
Daegu, South Korea
Unnamed facility
Daejeon, South Korea
Unnamed facility
Gwangju, South Korea
Change in HbA1c from baseline to end of treatment
Time frame: Baseline and up to 24 weeks
Change in fasting plasma glucose level
Time frame: Baseline and up to 24 weeks
Change in fasting serum insulin level
Time frame: Baseline and up to 24 weeks
Change in body weight
Time frame: Baseline and up to 24 weeks
Change in waist circumference
Time frame: Baseline and up to 24 weeks
Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG
Time frame: For 24 weeks
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Unnamed facility
Incheon, South Korea
Unnamed facility
Jeonju, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Wŏnju, South Korea
Unnamed facility
Kaohsiung City, Taiwan
Unnamed facility
Taichung, Taiwan
...and 2 more locations