Positive results reported from oral insulin trial

Jack Woodfield
Thu, 19 May 2016
Positive results reported from oral insulin trial
Oramed Pharmaceuticals, an Israeli drugmaker, has announced positive results from a new trial evaluating the safety and efficacy of an oral insulin capsule in patients with type 2 diabetes.

The drug, known as ORMD-0801, has been developed by Oramed Pharmaceuticals. The company's primary objective in this phase IIb study was to see if the drug reduced night-time blood glucose levels, and this was successfully achieved.

A problem with oral insulin is that it is often destroyed by the body before it has the intended effect. Oramed believes they have addressed this problem because ORMD-0801 uses a protective coating, and releases a dose of insulin that is high enough to deliver a clinically beneficial amount even if most of it is destroyed.

This new 28-day trial involved 180 adults with type 2 diabetes whose blood glucose levels were not adequately controlled by metformin. They took the oral insulin capsule before bed time and had their blood sugar monitored continuously overnight.

Compared to patients who took placebo, the oral insulin group had a mean night-time glucose reduction of 6.5 per cent. There were no serious adverse events following drug consumption, and no issues with hypoglycemia.

"This demonstration of safe and effective oral insulin delivery represents a transformative event in the treatment of type 2 diabetes," said Nadav Kidron, Oramed CEO.

Dr. Michael Berelowitz, Head of Oramed's Scientific Advisory Board, added: "These are very impressive results that confirm the efficacy of orally delivered intestinally absorbed insulin.

"The promise of this more physiological delivery system for insulin is the inhibition of hepatic glucose production, which was clearly demonstrated via the significant reduction in night-time glucose levels in patients who received ORMD-0801."

These results must now be replicated in a larger phase III trial before ORMD-0801 can be submitted for approval.

A number of other pharmaceutical firms are working on the development of an insulin pill; Novo Nordisk has recently put their own oral insulin into clinical trials.
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