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A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype

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A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Apr 2025

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At a glance

  • Drugs Autoimmune-diabetes-vaccine-(Diamyd)-Diamyd-Medical (Primary) ; Vitamin D
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms DIAGNODE-3
  • Sponsors Diamyd Medical AB

    • Most Recent Events

    • 12 Feb 2025 According to a Diamyd Medical AB media release, the company will receive USD 1.75 million in expanded collaboration support from Breakthrough T1D (formerly JDRF), in support of the DIAGNODE-3 Phase 3 trial to facilitate the potential submission of a regulatory filing for approval.
    • 29 Jan 2025 According to a Diamyd Medical AB media release, Recruitment in DIAGNODE-3, our pivotal Phase-3 study, continues to progress, with over 200 patients (more than needed for the planned early read-out in March-26)
    • 10 Jan 2025 According to a Diamyd Medical AB media release, its confirmed that the ongoing DIAGNODE-3 Phase 3 trial aligns with requirements for an Accelerated Approval, leveraging interim efficacy data based on stimulated C-peptide as the primary endpoint from approximately 170 evaluable participants who will complete their 15-month assessments by early 2026.

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