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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jul 2016

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

    • 07 Jun 2017 Biomarkers information updated
    • 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.
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