drugset / Trial / 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)

NCT03202563

Phase 4 Completed 71 enrolled LG Chem
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2017-08-09
Primary completion
2018-07-13
Completion
2018-12-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dapagliflozin Small molecule 10 mg
Subject Gemigliptin Small molecule 50 mg Oral
Background Metformin Small molecule 1000 mg