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A Double-Blind, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in T2DM Subjects With Inadequate Glycemic Control on Diet Control Only or on Diet Control and Metformin Monotherapy.

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A Double-Blind, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in T2DM Subjects With Inadequate Glycemic Control on Diet Control Only or on Diet Control and Metformin Monotherapy.

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 13 Feb 2023

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At a glance

  • Drugs Insulin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Oramed Pharmaceuticals

    • Most Recent Events

    • 09 Feb 2023 According to Oramed media release, the company will conduct a comprehensive analysis of the data from this study.
    • 07 Feb 2023 Status changed from active, no longer recruiting to discontinued based on the primary results analyzed at week 26 in theORA-D-013-1 protocol.
    • 05 Feb 2023 Status changed from discontinued to active, no longer recruiting.

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