NCT04754334

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

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: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 346 (actual)
• Sponsor: Oramed, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This double-masked placebo-controlled study will include approximately 450 subjects with inadequately controlled T2DM on diet control alone or on diet control and metformin monotherapy. Subjects will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a Double-Blind 26-week Treatment Extension Period.

Detailed description

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.

Conditions

• T2DM (Type 2 Diabetes Mellitus)

Interventions

Type	Name	Description
DRUG	ORMD-0801	Oral Insulin
OTHER	Placebo	Fish Oil

Timeline

• Start date: 2021-03-16
• Primary completion: 2023-01-13
• Completion: 2023-01-13
• First posted: 2021-02-15
• Last updated: 2023-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study