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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(R) Injected in the Morning or Evening in Patients With Type 1 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(R) Injected in the Morning or Evening in Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Insulin glargine (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms EDITION 4; EDITION-IV
  • Sponsors Sanofi

    • Most Recent Events

    • 01 Jun 2015 According to a Sanofi media release, based on the results from the EDITION clinical trial program (see also trial profiles 700208954, 700211632 and 700222490) Health Canada has approved insulin-glargine (toujeo).
    • 27 Feb 2015 According to a Sanofi media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of insulin glargine [Toujeo], based on results data from the EDITION clinical program.
    • 25 Feb 2015 The US FDA approved insulin glargine in adults with type 1 and type 2 diabetes mellitus, based on results data from the EDITION clinical program, according to a Sanofi media release.

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