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Phase 3, Randomized, Double-blind, Placebo/Active-controlled, Parallel-arm Trial to Assess Efficacy, Safety, and Pharmacokinetics of Dasiglucagon Relative to Placebo/GlucaGen as Rescue Therapy for Severe Hypoglycemia in Children With T1DM Treated With Insulin

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Trial Profile

Phase 3, Randomized, Double-blind, Placebo/Active-controlled, Parallel-arm Trial to Assess Efficacy, Safety, and Pharmacokinetics of Dasiglucagon Relative to Placebo/GlucaGen as Rescue Therapy for Severe Hypoglycemia in Children With T1DM Treated With Insulin

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Jun 2023

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At a glance

  • Drugs Dasiglucagon (Primary) ; Glucagon
  • Indications Hypoglycaemia; Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Zealand Pharma

    • Most Recent Events

    • 26 Jun 2023 According to a Zealand Pharma media release, the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for dasiglucagon injection for the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus.
    • 29 Jun 2021 Results (n=253) of three randomized, placebo-controlled phase 3 trials (2 in adults and 1 in pediatric subjects), presented at the 81st Annual Scientific Sessions of the American Diabetes Association
    • 22 Mar 2021 According to a Zealand Pharma media release, the U.S. Food and Drug Administration (FDA) has approved Zegalogue (dasiglucagon) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above, based on data from this and other two trials (NCT03688711 and NCT03378635).
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