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Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes

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Trial Profile

Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2022

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At a glance

  • Drugs Insulin aspart (Primary) ; Insulin degludec
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms onset7
  • Sponsors Novo Nordisk

Most Recent Events

  • 06 Jan 2020 According to an Food and Drug Administration media release, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved Fiasp(insulin aspart injection) 100 u/mL for use as a new mealtime insulin option for children with diabetes.The approval is based on the FDA's review of data from the onset 7 clinical trial.
  • 22 Aug 2019 According to a Novo Nordisk media release, the European Commission has granted an extension of the indication for Fiasp (fast-acting insulin aspart), approving it for the treatment of diabetes in adolescents and children (aged one year and above). This complements the previous indication, which covered adults only.
  • 10 May 2019 Results published in the Diabetes Care

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