This trial is to evaluate the efficacy and safety of CWP-0403 compared to Sitagliptin by proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled with metformin alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Anagliptin 100mg, tablet, twice a day (BID)
Sitagliptin 100mg, tablet, once a day (QD)
Kangbuk Samsung Hospital
Seoul, South Korea
The Change in HbA1c from baseline to week24.
Time frame: 0wk, 8wk, 16wk, 24wk
The proportion of subjects achieving HbA1c<7% at week24
Time frame: 0wk, 8wk, 16wk, 24wk
The proportion of subjects achieving HbA1c<6.5% at week24
Time frame: 0wk, 8wk, 16wk, 24wk
The change from baseline to week 24: Fasting plasma glucose
Time frame: 0wk, 24wk
change from baseline to week 24: Fasting serum insulin
Time frame: 0wk, 24 wk
change from baseline to week 24 in Fasting serum pro-insulin
Time frame: 0wk, 24wk
change from baseline to week 24 in Fasting serum c-peptide
Time frame: 0wk, 24wk
change from baseline to week 24 in HOMA-β
Time frame: 0wk, 24 wk
change from baseline to week 24 in HOMA-IR
Time frame: 0wk, 24 wk
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