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A Phase IIB/III Multicenter Randomized Trial to Evaluate the Combination of Low-Dose Cyclosporine and Omeprazole Versus Omeprazole Alone in Participants With New Onset Type 1 Diabetes.

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Trial Profile

A Phase IIB/III Multicenter Randomized Trial to Evaluate the Combination of Low-Dose Cyclosporine and Omeprazole Versus Omeprazole Alone in Participants With New Onset Type 1 Diabetes.

Status: Withdrawn prior to enrolment
Phase of Trial: Phase II/III

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Ciclosporin/omeprazole (Primary) ; Omeprazole
  • Indications Type 1 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms IIT
  • Sponsors Perle Bioscience
  • Most Recent Events

    • 15 Apr 2016 Status changed from recruiting to withdrawn prior to enrolment as reported by ClinicalTrials.gov.
    • 23 Jun 2015 As per a Perle Biosciences media release, the trial has been initiated. Seven designated trial sites are located within Italy, with two additional sites to be scheduled outside of Italy.
    • 27 Nov 2013 Planned initiation date changed from 1 Sep 2013 to 1 Feb 2014 as reported by ClinicalTrials.gov.
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