Dear colleagues and friends,
A dear colleague, shares this article written by Ellen Kathrine Bludd, published on January 19, 2024 in a digital bulletin from the Arctic University of Norway (UiT) and translated by us for this space. Let's see what they tell us about it...
There are approximately 425 million people worldwide with diabetes. Approximately 75 million of them inject insulin daily. Now, they may soon have a new alternative to syringes or insulin pumps. Scientists have found a new way to deliver insulin to the body more intelligently.
The new insulin can be consumed by taking a capsule or, better yet, inside a piece of chocolate.
Inside there are small nanocarriers in which insulin is encapsulated. The particles are 1/10,000 the width of a human hair and are so small that they can't even be seen with a normal microscope.
“This way of delivering insulin is more accurate because it delivers it quickly to the areas of the body that need it most. When insulin is administered with a syringe, it is distributed throughout the body, where it can cause unwanted side effects,” explains Professor Peter McCourt of Arctic University of Norway (UiT), who is one of the researchers behind the study.
The research was recently published in Nature Nanotechnology.
Delivered to the liver
It was researchers from the University of Sydney and the Sydney Local Health District who, in collaboration with the UiT, discovered many years ago that it was possible to deliver drugs to the liver using nanocarriers. Subsequently, the method was further developed in Australia and Europe.
Many medications can be taken orally, but until now people had to inject insulin into their bodies. McCourt explains that the problem with nanocarrier insulin is that it breaks down in the stomach and, therefore, does not reach where it is needed in the body. This has been a major challenge in developing a diabetes medication that can be taken orally.
But now researchers have solved this challenge.
“We created a layer to protect insulin from being broken down by stomach acid and digestive enzymes on its way through the digestive system, keeping it safe until it reaches its destination, namely, the liver,” says McCourt, a liver biologist.
The lining is then broken down in the liver by enzymes that are activated only when blood sugar levels are high, releasing insulin, which can then act on the liver, muscles and fat to remove sugar from the blood.
“This means that when the blood sugar level is high, there is a rapid release of insulin and, more importantly, when the blood sugar level is low, no insulin is released,” says Nicholas J. Hunt of the University of Sydney, who, together with Victoria Cogger, is leading the project.
He explains that this is a more practical and patient-friendly method for controlling diabetes because it greatly reduces the risk of a low blood sugar event, i.e., hypoglycemia, and allows for the controlled release of insulin depending on the patient's needs, unlike injections where all the insulin is released at once.
Fewer side effects
The new method works in a similar way to how insulin works in healthy people. The pancreas produces insulin, which first passes through the liver, where a large part of it is absorbed and keeps blood sugar levels stable. In the new insulin method, the nanocarrier releases insulin into the liver, where it can be absorbed or entered into the blood to circulate through the body.
“When insulin is injected under the skin with a syringe, much more of it goes to the muscles and adipose tissue than would normally happen if it were released from the pancreas, which can cause the accumulation of fats. It can also cause hypoglycemia, which can be potentially dangerous for people with diabetes.”
With the new method, there will be fewer side effects.
In addition, you don't need to prick yourself with a needle, and you can take the medication you need in a slightly more discreet way. In addition, this form of insulin does not need refrigeration.
Tested on baboons
Oral insulin has been tested on nematodes, mice and rats. And finally, the drug has been tested on baboons at Australia's National Baboon Colony.
“To make oral insulin palatable, we incorporated it into sugar-free chocolate; this approach was well received,” Hunt says.
According to him, 20 baboons participated in this study. When they received the medication, their blood sugar level dropped.
The baboons were normal, healthy baboons, but oral insulin was also tested on mice and rats that actually had diabetes. The mice and rats had no episodes of low blood sugar (hypoglycemia), weight gain, or fat accumulation in the liver, overcoming current challenges with injectables and other oral insulins.
What remains now is to test the new method on humans.
Ready to use in 2-3 years
“Human trials will begin in 2025, led by the spin-off company Endo Axiom Pty Ltd. The clinical trials are conducted in 3 phases; in the phase I trial, we will investigate the safety of oral insulin and critically analyze the incidence of hypoglycemia in healthy patients and type 1 diabetics.”
“Our team is very excited to see if we can reproduce in humans the results of absent hypoglycemia seen in baboons, as this would be a big step forward. The experiments follow strict quality requirements and must be carried out in collaboration with doctors to ensure that they are safe for test subjects,” says Hunt.
“After this phase I, we will know that it is safe for humans and we will investigate how it can replace injections for diabetic patients in phase 2 trials,” says the researcher.
The researchers hope that the new drug can be ready for use by everyone in 2 to 3 years.
