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)

A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Phase 4 Trial to Evaluate the Efficacy on Glycemic Variability and Safety of Gemigliptin 50mg q.d., Versus Dapagliflozin 10mg q.d. Added to Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone or Diabetes Medication Naïve Patient

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy on glycemic variability and safety of gemigliptin 50 mg orally administered once daily for 12 weeks compared with Dapagliflozin 10mg in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone or diabetes medication naïve patient

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-08-09
• Primary completion: 2018-07-13
• Completion: 2018-12-07
• First posted: 2017-06-28
• Last updated: 2019-02-15

Locations

1 site across 1 country: South Korea