New drug can create new life for diabetic patients, without needles

There are approximately 425 million people with diabetes worldwide. Around 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 smart insulin to the body.

The new insulin can be consumed by taking a capsule or, better yet, in a piece of chocolate.

Inside are tiny nanocarriers in which insulin is encapsulated. The particles are 1/10,000th the width of a human hair and so small that you can’t even see them under a normal microscope.

“This way of taking insulin is more precise because it delivers insulin quickly to the areas of the body that need it most. When you take insulin with a syringe, it travels throughout the body where it can cause unwanted side effects”, explains Professor Peter McCourt at the Arctic University of ITU Norway. He 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 UiT, discovered many years ago that it was possible to deliver drugs to the liver via nanocarriers. The method was later developed in Australia and Europe.

Many medications can be taken orally, but until now people had to inject insulin into the body. McCourt explains that the problem with insulin with a nanocarrier is that it breaks down in the stomach and therefore does not get to where it is needed in the body. This posed a major challenge in developing a diabetes drug that could be taken orally.

But now, researchers have solved this challenge.

“We created a coating to protect insulin from breakdown by stomach acid and digestive enzymes as it passes through the digestive system, keeping it safe until it reaches its destination, which is the liver,” says McCourt, a liver biologist. .

The coating is then broken down in the liver by enzymes that are only active when blood sugar levels are high, releasing insulin, which can then act in the liver, muscles and fats to remove the blood sugar.

“This means that when blood sugar is high, there is a rapid release of insulin and, more importantly, when blood sugar is low, no insulin is released,” explains Nicholas J. Hunt of the University of Sydney , who, with Victoria Cogger, is leading the project.

He explains that it is a more practical and patient-friendly method of diabetes management, as it significantly reduces the risk of hypoglycemia, i.e. low blood sugar, and allows controlled release of insulin in depending on the patient’s needs, unlike injections where all the insulin is released at once.

Fewer side effects

The new method works in the same way as insulin in healthy people. The pancreas produces insulin, which first passes through the liver, where much of it is absorbed and maintains stable blood sugar levels. In the new insulin method, the nanocarrier releases insulin into the liver, where it can be absorbed or enter the bloodstream to circulate throughout the body.

“When you inject insulin under the skin with a syringe, much more insulin goes to the muscles and fatty tissues than would normally occur if released from the pancreas, which can lead to accumulation This can also lead to hypoglycemia, which can be potentially dangerous for people with diabetes.

With the new method, these side effects will be fewer.

Plus, you don’t need to prick yourself with a needle and you can take the medications you need a little more discreetly. Additionally, this form of insulin does not need to be refrigerated.

Tested on baboons

Oral insulin has been tested on nematodes, mice and rats. Finally, the drug has now been tested on baboons in the National Baboon Colony in Australia.

“To make oral insulin palatable, we incorporated it into sugar-free chocolate; this approach was well received,” says Hunt.

He says 20 baboons participated in this study. When they received the drug, their blood sugar levels went down.

The baboons were normal, healthy baboons, but oral insulin was also tested in diabetic mice and rats. The mice and rats did not exhibit hypoglycemia (hypoglycemia), weight gain, or fat accumulation in the liver, overcoming current challenges with injectables and other oral insulins.

All that remains is to test the new method on humans.

Ready for use in 2 to 3 years

“Human trials will begin in 2025 and will be conducted by spin-off company Endo Axiom Pty Ltd. Clinical trials are carried out in 3 phases; In the phase I trial, we will study the safety of oral insulin and critically examine the incidence of hypoglycemia in healthy and type 1 diabetic patients.”

“Our team is very excited to see if we can replicate the absent hypoglycemia results seen in baboons in humans, as this would be a huge step forward. The experiments follow strict quality requirements and must be carried out in collaboration with doctors to ensure they are safe for test subjects,” says Hunt.

“After this phase, we will know that it is safe for humans and we will study how it can replace injections for diabetic patients in phase 2 trials,” explains the researcher.

Researchers hope the new drug can be used by everyone within 2 to 3 years.

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