A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes ( Switch 1)

Trial Profile

A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes ( Switch 1)

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Mar 2018

At a glance

  • Drugs Insulin degludec (Primary) ; Insulin aspart; Insulin glargine
  • Indications Type 1 diabetes mellitus
  • Focus Adverse reactions; Registrational
  • Acronyms BEGIN: SWITCH 1; SWITCH 1
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 26 Mar 2018 According to a Novo Nordisk media release, company has withdrawn the supplemental application from the US FDA for including data from SWITCH 1 and SWITCH 2 studies in the label for Tresiba.
    • 08 Dec 2017 Results assessing risk reductions across hypoglycaemia definitions with insulin degludec vs. insulin glargine U100 in SWITCH 1 and 2 studies, presented at the 2017 Congress of the International Diabetes Federation
    • 08 Dec 2017 Results of a post-hoc analyses from SWITCH 1 and SWITCH 2 studies, presented at the 2017 Congress of the International Diabetes Federation.
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