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G-Pen (Glucagon Injection) Compared to GlucaGen Hypokit (Glucagon) for Induced Hypoglycemia Rescue in Adults With T1D: A Phase 3 Multi-center, Randomized, Controlled, Single Blind, 2-way Crossover Study to Evaluate Efficacy and Safety

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Trial Profile

G-Pen (Glucagon Injection) Compared to GlucaGen Hypokit (Glucagon) for Induced Hypoglycemia Rescue in Adults With T1D: A Phase 3 Multi-center, Randomized, Controlled, Single Blind, 2-way Crossover Study to Evaluate Efficacy and Safety

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jun 2022

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At a glance

  • Drugs Glucagon (Primary)
  • Indications Hypoglycaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors XERIS Pharmaceuticals

    • Most Recent Events

    • 01 Jul 2022 Results published in the Diabetes, Obesity and Metabolism
    • 23 Aug 2021 According to a Xeris Pharmaceuticals media release, the Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) of Gvoke Kit for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above, based on data from this trial.
    • 12 Feb 2021 According to a Xeris Pharmaceuticals media release, the European Commission (EC) has approved Ogluo™ (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus, based on data from this trial.

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