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

Type 2 Diabetes Mellitus Clinical Trial

Official title: A Double-Blinded, Placebo-controlled, Double Dummy, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With T2DM With Inadequate Glycemic Control on 1, 2 or 3 Oral Glucose-lowering Agents.

Status Terminated

Clinical Trial Summary

In this randomized, double-blind, double-dummy, placebo-controlled study, approximately 675 eligible subjects with type 2 diabetes and inadequate control on at least one and up to 3 oral glucose-lowering agents will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a 26-week Double-Blind Treatment Extension Period.

Clinical Trial Description

Screening Period Subjects will provide a written informed consent during Screening Visit 1. They will be scheduled to return to the clinic 10 days prior to randomization for Screening Visit 2. At this visit, a 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 arms of the study treatment.

3.1.2 26-Week Double-Blind Treatment Period After the Screening Period, subjects will be randomized to 26 weeks of the Double-Blind Treatment Period. In a double-blind, double dummy randomization scheme, subjects will either receive ORMD-0801 administered once-daily at night (1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner); or ORMD-0801 8 mg (1 x 8 mg capsule) administered twice daily, each morning approximately 45 minutes (±15 minutes) prior to breakfast and each night prior to bedtime (between 8 PM to 12 Midnight and no sooner than 1 hour after dinner) or matching placebo. Subjects will receive 1 capsule approximately 45 minutes (±15 minutes) prior to breakfast and 1 capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner.

During the Double-Blind 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 (± 1-day) 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 ± 1-day window.

3.1.3 26-Week Double-Blind Treatment Extension Period Following the completion of the Double-Blind Treatment Period, subject will enter a 26-week Double-Blind Treatment Extension Period. Subjects previously randomized to placebo during the Double-Blind Treatment Period will be randomized to receive either ORMD-0801 8 mg QD or 8 mg BID for the duration of the Double-Blind Treatment Extension Period. Subjects previously randomized to 8 mg QD or 8 mg BID during the Double-Blind Treatment Period will remain in the same treatment arm for the duration of the Double-Blind Treatment Extension Period. The Extension Period treatment assignments will remain blinded for the duration of the study. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT04606576
• Study type: Interventional
• Source: Oramed, Ltd.
• Status: Terminated
• Phase: Phase 3
• Start date: December 15, 2020
• Completion date: January 13, 2023