View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
July 27, 2022

Oramed reaches 50% enrolment in Phase III trial of insulin capsule

The ORA-D-013-2 trial is enrolling 450 type 2 diabetes patients with insufficient glycemic control.

Oramed Pharmaceuticals has enroled and randomised more than 50% of participants in its second Phase III ORA-D-013-2 international multicentre trial of ORMD-0801, an oral insulin capsule, to treat type 2 diabetes (T2D).

About 450 T2D patients with insufficient glycemic control, handling their condition with diet alone or with diet along with metformin monotherapy are being recruited in the ORA-D-013-2 double-blind trial.

The company’s proprietary lead candidate, ORMD-0801 is being assessed in two pivotal Phase III trials, ORA-D-013-1 and ORA-D-013-2, and can become the first treatment for diabetes by orally delivering insulin at an early stage.

The Phase III ORA-D-013-1 trial completed subject enrolment in May this year and expects to receive top line findings in January next year.

Oramed CEO Nadav Kidron said: “We are very pleased as we head into the latter half of enrolment for our ORA-D-013-2 trial, especially after having just completed 100% enrolment in our larger ORA-013-1 trial which randomised a total of 710 patients.

“Together, these trials are the world’s first Phase 3 oral insulin trials conducted under a US FDA IND.”

The ORA-D-013-2 trial is being conducted under the US Food and Drug Administration (FDA ) Investigational New Drug Application (IND).

In this trial, the subjects will be randomised in 1:1 two cohorts and administered with 8mg ORMD-0801 or placebo at night.

The efficacy of ORMD-0801 compared to placebo in enhancing glycemic control as evaluated by A1c over a treatment period of 26 weeks will be the trial’s primary endpoint.

Comparing the ORMD-0801 vs placebo in maintaining the glycemic control for 52-week treatment period will be the secondary endpoint of the trial.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy


Thank you for subscribing to Clinical Trials Arena