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
Phase of Trial: Phase III
Latest Information Update: 13 Dec 2017
At a glance
- Drugs Insulin glargine (Primary)
- Indications Type 1 diabetes mellitus
- Focus Therapeutic Use
- Acronyms EDITION JUNIOR
- Sponsors Sanofi
- 08 Dec 2017 Planned End Date changed from 18 Jan 2019 to 19 Dec 2018.
- 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.