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A Placebo-controlled, Multi-center, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Therapy

Trial Profile

A Placebo-controlled, Multi-center, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Therapy

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 12 Nov 2019

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At a glance

  • Drugs Insulin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Oramed Pharmaceuticals
  • Most Recent Events

    • 12 Nov 2019 According to an Oramed Pharmaceuticals media release, Oramed will be held a teleconference call today to review this Phase IIb data and will also host an investor event and an additional teleconference call to further review the data details of this ORMD-0801 Phase IIb trial.
    • 12 Nov 2019 According to an Oramed Pharmaceuticals media release, Oramed expects to announce the results from the second cohort in the first quarter of 2020 and further discussions with the U.S. FDA about Phase III trials.
    • 12 Nov 2019 Primary endpoint (Mean change in HbA1C from baseline to Week 12 of the treatment period: Initial cohort of ORMD-0801 once-daily (32mg per day), twice-daily (64mg per day) versus corresponding placebo for each treatment arm) has been met, according to an Oramed Pharmaceuticals media release.
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