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A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus With a 6 Month Safety Extension Period

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A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus With a 6 Month Safety Extension Period

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Nov 2020

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At a glance

  • Drugs Insulin glargine (Primary) ; Antihyperglycaemics
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms EDITION Japan 2; EDITION-JP-II
  • Sponsors Sanofi

    • Most Recent Events

    • 25 Sep 2020 Results of pooled analysis from NCT02855684; NCT01689142 and NCT01676220 assessing efficacy and safety of Gla-300 in East Asian population with type 2 diabetes, presented at the 56th Annual Meeting of the European Association for the Study of Diabetes
    • 09 Jun 2015 Results presented at the 75th Annual Scientific Sessions of the American Diabetes Association.
    • 19 Sep 2014 Primary endpoint has been met (Change from baseline in HbA1c), according to the results presented at the 50th Annual Meeting of the European Association for the Study of Diabetes.

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