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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: 06 Feb 2019

At a glance

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

    • 20 Dec 2018 According to a Diamyd Medical AB media release, 75 percent of patients (three quarters, 80 out of 106 patients) are now enrolled in this study.In January, a new clinic is expected to open for recruitment in Rotterdam, the Netherlands.The company expects full recruitment in this trial in the first quarter of 2019.
    • 26 Sep 2018 Planned End Date changed from 1 Mar 2020 to 1 Aug 2020.
    • 26 Sep 2018 Planned primary completion date changed from 1 Mar 2020 to 1 Aug 2020.
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