Dr. Hanid Audish Discusses New Study with Oramed
Type 2 diabetes mellitus presents several relevant health risks for patients, necessitating that scientists perform crucial research to improve the quality of life of individuals that have inadequate control on glucose-lowering agents. Dr. Hanid Audish and his team at Encompass Clinical Research are currently performing a new study to test oral insulin capsules that may expand treatment options for patients impacted by the disease.
The study, performed in collaboration with Integrium and sponsored by Oramed, Ltd., is the first of its kind to test a novel oral insulin in patients with Type 2 diabetes mellitus. The trial is set to evaluate both the efficacy and safety of the oral insulin capsule produced by Oramed, and will test results via a randomized, double-blind, double-dummy, placebo-controlled study. 675 eligible subjects that have type 2 diabetes and inadequate control while on one to three oral glucose-lowering agents will undergo a 21-day screening period, a 26-week double-blind treatment period, and a 26-week double-blind treatment extension period for participation in the study.
For the screening, subjects will provide written informed consent, whereupon they will be scheduled to return to the clinic 10 days prior to randomization for Screening Visit 2. During Screening Visit 2, a CGM sensor will be placed on the subject with appropriate instructions for a 10-day blinded CGM data collection by the research site. After 10 days, subjects will return to the clinic to have the CGM sensor removed. The subjects will then be randomized to one of the three arms of the study treatment.
After the screening period, the subjects will be engaged in a 26-week double blind treatment period. Subjects will receive either ORMD-0801 administered once at night, ORMD-0801 twice daily, or a matching fish oil placebo. Subjects receiving ORMD-0801 BID will receive a capsule about 45 minutes prior to breakfast and another between 8 PM and midnight, no sooner than one hour after dinner.
For the double-blind treatment period, test subjects will return to the clinic during in several intervals throughout the duration of the study. These intervals include Week 6, Week 12, Week 18, Week 24, and Week 26. 10 days prior to Week 26, subjects will return for CGM application and will return week 26 for CGM removal and the end of the double-blind treatment period visit. Subjects that were randomized to placebo during the double-blind treatment period will be randomized ORMD-0801 QD (oral insulin, once per day) or ORMD-0801 BID (oral insulin, twice per day). The subjects that were previously randomized to ORMD-0801 QD or ORMD-0801 BID will remain stay in the same treatment arm for the extension period. Throughout the extension period, assignments will remain blinded.
As of March 2021, Dr. Hanid Audish notes Oramed has recently made an announcement that it has reached 25% randomization in the enrollment for the trial. This puts the study on pace to complete randomization of the 675 patients by the end of 2021 and receive topline results in 2022. The trial is being performed alongside ORA-D-013-2 and combined will recruit 1,125 patients to evaluate ORMD-0801’s efficacy and safety. Dr. Hanid Audish acknowledges that ORMD-0801 can potentially be the first commercial oral insulin capsule for type 2 diabetes treatment, which could expand treatment options available for those that suffer from the condition.