A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd® Therapy Administered into Lymph Nodes Combined with Oral Vitamin D to Investigate the Impact on the Progression of Type 1 diabetes

Trial Profile

A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd® Therapy Administered into Lymph Nodes Combined with Oral Vitamin D to Investigate the Impact on the Progression of Type 1 diabetes

Recruiting
Phase of Trial: Phase II

Latest Information Update: 26 Mar 2018

At a glance

  • Drugs GAD65 vaccine (Diamyd) (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms DIAGNODE-2
  • Sponsors Diamyd Medical AB
  • Most Recent Events

    • 02 Mar 2018 According to a Diamyd Medical AB media release, to date, 9 patients have been included in the trial and approximately 100 patients are planned to be screened in order for 80 patients to be included. The Company estimates that the rate of recruitment is in line with the target; fully recruited trial in November 2018.
    • 09 Feb 2018 According to a Diamyd Medical AB media release, first five patients are enrolled in the study and one patient is injected with Diamyd vaccine after a 30-day period of oral treatment with vitamin D.
    • 24 Jan 2018 According to a Diamyd Medical AB media release, company plans to complete the enrollment within 12 months.
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