The purpose of this study is evaluate the long term safety and efficacy of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
DWP16001 Amg, Tablets, Orally, Once daily
Daewoong pharmatceutical
Seoul, South Korea
Changes from baseline in Adverse events (AEs) and adverse events of special interest (AESIs)* at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
\*Hypoglycemia, urinary tract infection, genital infection, pollakiuria, or polyuria
Time frame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Changes from baseline* in HbA1c at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
\* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW\_DWP16001301)
Time frame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Changes from baseline* in FPG at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
\* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW\_DWP16001301)
Time frame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Proportion of subjects achieving HbA1c target of < 7% at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
\* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW\_DWP16001301)
Time frame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
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