The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin 25 mg and metformin
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
214
To be orally administered once daily for 52 weeks.
To be orally administered once daily for 52 weeks. This arm will be switched to teneligliptin from week 24.
Seoul National University Hospital
Seoul, South Korea
Changes from baseline HbA1c at week 24
Time frame: Baseline (week 0) and week 24
Changes from baseline FPG at week 24
Time frame: Baseline (week 0) and week 24
Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24
Time frame: Baseline (week 0) and week 24
Changes from baseline in BMI at week 24
Time frame: Baseline (week 0) and week 24
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