Researchers at Hadassah-University Hospital have for the first time shown that insulin in an oral pill can safely reach the bloodstream of healthy human volunteers. This finding, by scientists at the Ein Kerem hospital for Emisphere Technologies in Tarrytown, New York, is expected – pending Health Ministry approval – to be followed by tests on adult-onset (type II) diabetes patients. It was previously found successful in healthy dogs and pigs.Prof. Hanoch Bar-On and Dr. Miriam Kidron of the hospital’s diabetes unit noted yesterday that 30-40 percent of people with type II diabetes eventually have to inject themselves regularly with insulin even though the islet cells in their pancreas still work. This is because oral drugs that try to reduce glucose intolerance prove inadequate.
Type II diabetes usually appears in the middle-aged, especially those who are overweight and get little exercise, but has been diagnosed increasingly in younger people because of a “junk food” diet, overweight, and inadequate physical activity.
Juvenile-onset diabetes (type I), which is much less common, is an autoimmune disorder of genetic origin in which the body’s immune system mistakenly attacks the islet cells in the pancreas, causing them to stop producing insulin that metabolize sugars. Without insulin injections or infusions, they would die.
Bar-On said his department worked for 15 years on its own oral insulin pill and even received two patents, but the lack of $2 million in financial backing from pharmaceutical investors forced the staff to abandon the project.
“Since our team is regarded as the best in the world involved in slowing the absorption of insulin, the New York company approached us and asked us to carry out clinical trials. The American insulin pill works differently from our own. In phase I trials on 12 healthy volunteers, we show that the active ingredient in the Emisphere pill can pass through the intestine and go on to the liver and the bloodstream within 20 or 30 minutes,” he said.
Kidron added that without a special “promoter” that enhances absorption of the large-molecule insulin peptide, insulin in pill form would be destroyed by the digestive system and break down before release into the bloodstream. She added that the path of the insulin from the pill “imitates nature,” in that it passes to the liver and then to the bloodstream; injected insulin goes straight to the bloodstream.
Bar-On and Kidron added that testing the Emisphere pill, which has not yet been given a name, on type I diabetics is not contemplated at this stage.
“At this point, the pill is not suited to juvenile-onset diabetics, because timing is very important. If such a patient swallows the pill, it’s difficult to control the release of insulin over time that would balance the blood sugar level. Some mechanism that offers better control of insulin release could eventually make the oral insulin pill practical for type I diabetics,” Kidron explained.