71
Participants
Start Date
August 9, 2017
Primary Completion Date
July 13, 2018
Study Completion Date
December 7, 2018
Gemigliptin 50mg
For patients who have been randomized to Gemigliptin(Experimental arm), the patients continue to take a gemigliptin 50mg 1 tablet by once daily during study treatment period(Visit 3(day 1)\~Visit 6(day 91))
Dapagliflozin 10mg
For patients who have been randomized to Dapagliflozin(Active Comparator arm), the patients continue to take a dapagliflozin 10mg 1 tablet by once daily during study treatment period(Visit 3(day 1)\~Visit 6(day 91))
Diet/exercise questionnaire
"doing exercise with about intermediate intensity(50\~70%) for ≥150minutes in total over at least 3 times(every other day) weekly should be recommended and regular diet without greater changes in life style as much as possible during the whole study period.~the questionnaire regarding diet/exercise will be collected at -day 6, day 1, day29, day85, day 91"
Continuous Glucose Monitoring System(CGMS)
For patients who have been screening completely, the subjects will be attached CGMS(ipro-2) twice from Visit 2(-day 6) to Visit 3(day 1) and Visit 5(day 85) to Visit 6(day 91)
Metformin
For patients who have been taking metformin, the patients who had taken at least 1000 mg of metformin daily and continue the same dosage and administration as before participant in the study
Samsung Medical Center, Seoul
Lead Sponsor
LG Chem
INDUSTRY