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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: 04 Jun 2024

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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

    • 31 May 2024 According to a Zealand Pharma media release, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for dasiglucagon solution for injection in the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus based in the results of 3 phase3 pivotal trials in adults and children with diabetes.
    • 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

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