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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

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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 of Trial: Phase IV

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Gemigliptin (Primary) ; Dapagliflozin
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms STABLE II
  • Sponsors LG Chem

    • Most Recent Events

    • 11 Jun 2019 Primary endpoint (Changes from baseline MAGE(Mean amplitude of glycemic excursion) at week 12) has been met, according to Results presented at the 79th Annual Scientific Sessions of the American Diabetes Association.
    • 11 Jun 2019 Results assessing safety and efficacy of gemigliptin vs dapagliflozin in Patients with Type 2 diabetes mellitus patients, presented at the 79th Annual Scientific Sessions of the American Diabetes Association.
    • 13 Feb 2019 Status changed from active, no longer recruiting to completed.

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