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A Phase I/II, 3-Arm, Open Label, Single Centre Study to Investigate the Safety and Effect of Oral GABA Therapy on Beta-Cell Regeneration in Type 1-diabetes Patients

Trial Profile

A Phase I/II, 3-Arm, Open Label, Single Centre Study to Investigate the Safety and Effect of Oral GABA Therapy on Beta-Cell Regeneration in Type 1-diabetes Patients

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Nov 2019

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At a glance

  • Drugs Alprazolam (Primary) ; Gamma amino butyric acid Diamyd (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Adverse reactions
  • Acronyms ReGenerate-1
  • Most Recent Events

    • 11 Nov 2019 According to a Diamyd Medical AB media release, the initial safety and dose escalation part of this study has been completed.The safety data from the six patients included in this first part of the trial has been evaluated by an independent Data Safety Monitoring Board (DSMB) who recommends that the main study can start. Metabolic results from the now completed safety and dose escalation part are being compiled and will be presented later this year.
    • 17 Sep 2019 According to a Diamyd Medical AB media release, the company is planning additional analyses of this trial.
    • 27 Aug 2019 According to a Diamyd Medical AB media release, the dose-escalation part of this study is expected to be finalized this autumn and the second part is expected to start recruiting patients later this year.
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