The purpose of this study is to compare the efficacy and safety of ASP1941 50mg once daily in combination with metformin and sitagliptin against placebo in combination with metformin and sitagliptin over a 24 week treatment period in subjects with type 2 diabetes mellitus with inadequate glycemic control on metformin and sitagliptin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
143
Site KR00019
Dong Gu Gwangju, Dong Gu Gwangju, South Korea
Site KR00008
Gangwon-do, Gangwon-do, South Korea
Change from baseline in HbA1c at the end of treatment
Time frame: at 24 weeks
Change from baseline in Fasting plasma glucose at the end of treatment
Time frame: at 24 weeks
Change from baseline in Fasting serum insulin at the end of treatment
Time frame: at 24 weeks
Change from baseline in Body weight at the end of treatment
Time frame: at 24 weeks
Change from baseline in Waist circumference at the end of treatment
Time frame: at 24 weeks
Safety assessed by development of adverse events, vital signs, laboratory tests, and 12-lead ECG
ECG: Electrocardiogram
Time frame: up to 24 weeks
Number of subjects achieving the target HbA1c(<6.5% and <7.0%) at each visit
Time frame: at 4, 8, 12, 16 and 24 weeks
Percentage of subjects achieving the target HbA1c(<6.5% and <7.0%) at each visit
Time frame: at 4, 8, 12, 16 and 24 weeks
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Site KR00020
Jeollabuk-do, Jeollabuk-do, South Korea
Site KR00021
Kyungsangnam-do, Kyungsangnam-do, South Korea
Site KR00002
Busan, South Korea
Site KR00003
Busan, South Korea
Site KR00007
Daegu, South Korea
Site KR00011
Daegu, South Korea
Site KR00018
Gyeonggi-do, South Korea
Site KR00022
Gyeonggi-do, South Korea
...and 12 more locations