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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

Trial Profile

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: 28 Apr 2025

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At a glance

Most Recent Events

  • 21 Apr 2025 According to a Diamyd Medical AB media release, The Company is currently enrolling only patients with the appropriate HLA genotype in its Phase 3 trial DIAGNODE-3 trail and a registrational Phase 3 readout expected within 12 months.
  • 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)

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