The trial was conducted in the United States under a Food and Drug Administration Investigational New Drug protocol.
The prospective, randomized, double-blind, placebo controlled study in patients with established type 1 diabetes is evaluating the safety and impact of ORMD-0801 on the exogenous insulin requirements in 24 type 1 diabetics patients.
Type 1 diabetes is an autoimmune disease in which the pancreatic beta cells responsible for insulin secretion are attacked by the immune system.
In the absence of self-produced insulin and the concomitant glycemic control, there is a need to supply extraneous insulin in order to regain glycemic control and prevent future disease complications that include heart disease, blood vessels disease, nerve and eye disease, infections, hypoglycemic events and many more ailments.
According to the International Diabetes Federation, type 1 diabetes is on the rise at a rate of 3% per year and currently affects approximately 36 million people worldwide – about 10% of the global diabetes population. The disease was formerly known as juvenile diabetes, and currently affects both pediatric and adult populations.