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A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification (DUAL- Intensification)

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Trial Profile

A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification (DUAL- Intensification)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jan 2020

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At a glance

  • Drugs Insulin degludec/liraglutide (Primary) ; Insulin aspart
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms DUAL Intensification
  • Sponsors Novo Nordisk

Most Recent Events

  • 23 Jan 2019 According to a Novo Nordisk media release, Xultophy was approved by Health Canada in April 2018 based on data from the DUAL clinical development program.
  • 24 May 2016 According to a Novo Nordisk media release, insulin degludec and liraglutide fixed dose combination (Xultophy) was approved in Europe in September 2014.
  • 24 May 2016 According to a Novo Nordisk media release, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. FDA unanimously recommended the approval of insulin degludec and liraglutide fixed dose combination (IDegLira) for the treatment of adults with type 2 diabetes. The recommendation was based on data from several clinical trial including the phase III DUAL program.

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