Trial to Evaluate the Efficacy on Glycemic Variability and Safety of Gemigliptin Compared With Dapagliflozin Added on Metformin Alone or Diabetes Medication Naïve Patient in Type 2 Diabetes Mellitus (Stable II Study)

PHASE4CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

August 9, 2017

Primary Completion Date

July 13, 2018

Study Completion Date

December 7, 2018

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

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))

DRUG

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))

PROCEDURE

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"

DEVICE

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)

DRUG

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

Trial Locations (1)

06351

Samsung Medical Center, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LG Chem

INDUSTRY

NCT03202563 - Trial to Evaluate the Efficacy on Glycemic Variability and Safety of Gemigliptin Compared With Dapagliflozin Added on Metformin Alone or Diabetes Medication Naïve Patient in Type 2 Diabetes Mellitus (Stable II Study) | Biotech Hunter | Biotech Hunter