“This demonstration of safe and effective oral insulin delivery represents a transformative event in the treatment of type 2 diabetes,” said
This US based double blind, 28 day, randomized study of 180 adult type 2 diabetic patients showed a statistically significant decrease in the primary endpoint, pooled night-time glucose mean percentage change of 6.47% from run-in, between placebo and active cohorts (p=0.0268). The study additionally demonstrated a good safety profile with no drug related serious adverse events.
“These are very impressive results that confirm the efficacy of orally delivered intestinally absorbed insulin,” said Dr.
The Company plans to present and publish more comprehensive data in the future.
Conference Call today, May 18, at 11:00 am Eastern Time
Oramed will host a conference call to discuss the study results.
Interested parties may access the call at: +1-866-254-0808 (US) or +44-145-254-1003 (
About the Phase IIb Oral Insulin Study
The double-blind, randomized Phase IIb study of 180 patients with type 2 diabetes was initiated on
For more information on the study, which does not form a part of this press release, see: https://clinicaltrials.gov/ct2/show/NCT02496000?term=oramed&rank=5
ORMD-0801 has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or even eliminating late-stage complications. Orally administered insulin is expected to enhance patient compliance. In addition, intestinally absorbed-oral insulin mimics insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.