A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
283
Participants receive Evogliptin 5mg orally once a day
Participants receive placebo to match Evogliptin 5mg orally once a day
Participants receive Dapagliflozin orally once a day
Seoul St, Mary's Hospital,The Catholic University of Korea
Seoul, South Korea
Change from baseline in HbA1c (%) After 24 weeks
Time frame: 24 weeks
Change from baseline in FPG(mg/dL) After 24 weeks
Time frame: 24 weeks
Change from baseline in HbA1c response rate(<7.0% ,<6.5%) After 24 weeks
Time frame: 24 weeks
Change from baseline in 7-point SMBG After 24 weeks
Time frame: 24 weeks
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Metformin are administered at the same dose and formulation.