A Multi-center, Open-label, Extension study to Evaluate the long term Safety and Efficacy of DWP16001 add-on to metformin in Patients with type 2 diabetes mellitus inadequately controlled on metformin
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
159
DWP16001 Tablets
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\_DWP16001302)
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\_DWP16001302)
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\_DWP16001302)
Time frame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
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