A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus

Screening Period The investigator will review the aim of the study, study procedures, potential risks, and benefits with the volunteers. These subjects will then sign a written informed consent during Screening Visit 1. They will be instructed to return to the clinic 10 days prior to randomization (Visit 1) for Screening Visit 2. At this visit, a continuous glucose monitoring (CGM) sensor will be placed with appropriate instructions by the study team for a 10-day blinded CGM data collection by the site. Subjects will then return to the clinic after 10 days (± 1-day) for removal of the CGM sensor. The subjects will be randomized to one of the three study treatment arms. 26-Week Double-Masked Treatment Period After the Screening Period, subjects will be randomized to 26 weeks of the Double-Blind Treatment Period consisting of ORMD-0801 8 mg (1 x 8 mg capsule), or placebo in a 1:1 randomized fashion. Medication will be administered once daily at night prior to bedtime (between 8 PM to 12 Midnight and no sooner than 1 hour after dinner). During the Double-Masked Treatment Period commencing at Week 0 (Visit 1, CGM removal), subjects will return to the clinic at the following intervals: Week 6 - Visit 2; Week 12 -Visit 3; Week 18 - Visit 4; Week 24 - Visit 5 (10 days prior to Week 26 for CGM application) and Week 26 - Visit 6 (CGM removal and end of Double-Blind Treatment Period visit). The visit requiring CGM application will occur 10 days prior to the CGM removal visit within a ± 1-day window 26-Week Double-Masked Treatment Extension Period Following the completion of the Double-Blind Treatment Period, subjects will enter a 26-week Double-Blind Treatment Extension Period. Subjects will remain on the same treatment regimen and continue to receive the same medication for the duration of the Double-Blind Treatment Extension Period. The Extension Period treatment assignments will remain blinded for the duration of the study. Visits will occur at the following intervals during the 26-Week Double-Masked Treatment Extension Period: Week 30 - (Visit 7); Week 40 - Visit 8; Week 50 - Visit 9 (10 days prior to Week 52 for CGM application); and Week 52 - Visit 10 (CGM removal and end of Double-Blind Treatment Extension Period visit). The visit requiring CGM application will occur 10 days prior to the CGM removal visit within a ± 1-day window. All subjects completing the trial will return to the clinic in 2 weeks ± 3 days for a Safety Follow-Up Visit. Subjects withdrawing prematurely from the trial, will have the early termination (ET) visit procedures completed. All patients will continue to be followed in accordance with ITT principles to avoid a loss to follow-up and missing data.