The purpose of this study is to determine the efficacy and safety of DWP16001 compared to active drug in the treatment of type 2 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
270
Tablets, Orally, Once daily
The Catholic University of Korea Bucheon St. Mary's Hospital, Republic of Korea
Bucheon-si, South Korea
Change from Visit 2(Randomization) in HbA1c level at Week 24 after administation of the IP
HbA1c level at Week 24 after administration of the IP
Time frame: at Week 24
Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP
HbA1c level at Weeks 6, 12, and 18 after administration of the IP
Time frame: at weeks 6, 12, and 18
Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP
FPG level at Weeks 6, 12, 18, and 24 after administration of the IP
Time frame: at weeks 6, 12, 18, and 24
Proportions of subjects who achieved HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP
HbA1c level \< 7% at Weeks 6, 12, 18, and 24 after administration of the IP
Time frame: at weeks 6, 12, 18, and 24
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