A new sugar-free intelligent insulin that can be administered via capsule or, even better, “within a piece of chocolate.” Diabetes patients who are reliant on daily insulin injections may soon be able to realise the goal of an existence devoid of needles. This is a prevalent issue that affects a considerable proportion of the global population, given that an estimated 425 million individuals suffer from sickle cell disease, and 75 million of them require insulin daily. They may have access to an alternative to syringes or insulin pumps within the next few years. Scientists have developed a new method for delivering “smart” insulin to the body. Their research findings have been published in the “Nature Nanotechnology.” Experts predict that human trials will commence in 2025, with the expectation that the novel medication will be commercially available within two to three years.
Precisely, the study’s authors have successfully encapsulated insulin within minuscule nanocarriers. The obtained particles are 1/10,000th of the width of a human hair in dimension. They are so minute in size that not even a standard microscope can discern them. This method of administering insulin is more precise because it rapidly delivers the drug to the areas of the body that require it, explains Peter McCourt of UiT Norway’s Arctic University, one of the study’s researchers. He continues by stating that when the medication is administered via syringe, it spreads throughout the body and can cause undesirable side effects.
Destination: liver, the only stop: that’s the mission
Long ago, researchers from UiT, the local health district of Sydney, and the University of Sydney jointly reported on the feasibility of delivering medications to the liver via nanocarriers. Further development of the method took place in Europe and Australia. While numerous medications are oral, insulin is not. McCourt explains that the issue associated with its use in nanocarriers is its gastric degradation, which impedes its delivery to the intended site. This presented a formidable obstacle, which the researchers now assert they have surmounted. McCourt states that the group has developed a coating that safeguards insulin against the deterioration caused by digestive enzymes and gastric acids as it travels through the digestive tract, ensuring it remains intact until it reaches its intended site, the liver.
The system’s functioning is considerably more akin to that of healthy individuals. Enzymes that are active only when blood sugar levels are high degrade the insulin coating in the liver, releasing the molecule that can eliminate sugar from the blood by acting in the liver, muscles, and fat. This implies that insulin is rapidly released in response to high blood sugar levels and remains dormant during periods of low blood sugar, explains Nicholas J. Hunt of the University of Sydney, who co-directs the project with colleague Victoria Cogger.
By permitting the controlled release of insulin per the patient’s requirements and substantially reducing the risk of hypoglycemia, this method distinguishes itself as more practical and individualised in managing diabetes than injections. The mechanism of action closely resembles that of insulin in healthy individuals. In individuals unaffected by the condition, a significant portion of the insulin produced by the pancreas is absorbed by the liver, which regulates blood sugar levels. The method devised by the specialists involves the discharge of insulin from the nanocarrier into the liver, from which it can either be absorbed or enter the bloodstream for circulation. It also results in fewer adverse effects, as stated by the experts. And no needles.
Oral insulin has been tested on worms (nematodes) and mice and rats with diabetes. And now it has been tested on baboons in the National Baboon Colony in Australia. To make oral insulin appealing, the team has incorporated it into sugar-free chocolate, and this approach has been well-received, Hunt says. Twenty healthy baboons took part in this study, received the medication, and their blood sugar levels decreased. Now, the final step remains: testing the new method on humans.
Phase 1 human trials will be led by the spin-off company Endo Axiom Pty. They will investigate the safety and incidence of hypoglycemia in healthy individuals and those with type 1 diabetes. Human trials are scheduled to commence in 2025, according to Hunt.
Experimental protocols adhere to rigorous quality standards and necessitate physicians’ involvement to guarantee test subjects’ safety. Phase 2 studies will investigate how the technology could replace injections for diabetic patients, assuming everything goes as planned. Researchers aim to have the new medication ready within two to three years.
