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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Apr 2016

At a glance

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

    • 07 Jun 2017 Biomarkers information updated
    • 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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