A Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus

• Research type

  Research Study

• Full title

  A Double-Blinded, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Diet Control Alone or on Diet Control and Glucose-lowering Agents as Monotherapy.

• IRAS ID

  1004384

• Contact name

  Kamlesh Khunti

• Contact email

  kk22@le.ac.uk

• Sponsor organisation

  Oramed Ltd.

• Eudract number

  2021-004226-30

• Clinicaltrials.gov Identifier

  NCT04754334

• Research summary

  This is double-blind placebo-controlled study will include approximately 450 subjects with inadequately controlled Type 2 Diabetes Mellitus on diet control alone or on diet control and glucose-lowering agents as monotherapy. The purpose of this research study is to test an experimental drug called ORMD-0801, an orally administered formulation of insulin. Subjects will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a Double-Blind 26-weekTreatment Extension Period prior to Screening.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  22/LO/0076

• Date of REC Opinion

  29 Mar 2022

• REC opinion

  Further Information Favourable Opinion