6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus Injected Once Daily in Children and Adolescents Age 6 - 17 Years With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period

Trial Profile

6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus Injected Once Daily in Children and Adolescents Age 6 - 17 Years With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period

Recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Oct 2017

At a glance

  • Drugs Insulin glargine (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms EDITION JUNIOR
  • Sponsors Sanofi
  • Most Recent Events

    • 13 Jul 2017 Planned End Date changed from 1 Oct 2018 to 18 Jan 2019.
    • 13 Jul 2017 Planned primary completion date changed from 1 Mar 2018 to 20 Jun 2018.
    • 10 Jun 2017 Biomarkers information updated
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