About 425 million individuals worldwide live with diabetes, with roughly 75 million administering insulin injections daily. A potential substitute for syringes or insulin pumps is on the horizon as scientists unveil a novel method for supplying the body with smart insulin. This new insulin can be ingested via a capsule or, even more conveniently, embedded within a piece of chocolate.
Contained within these are minuscule nano-carriers encapsulating the insulin, with particles so diminutive they elude detection under a standard microscope, measuring just 1/10,000th the width of a human hair.
Professor Peter McCourt from UiT Norway’s Arctic University, part of the team behind the study, explains the precision of this insulin delivery method. He emphasizes its ability to swiftly target specific areas in need, unlike conventional syringe administration, which disperses insulin throughout the body, potentially leading to unintended side effects.
Published recently in Nature Nanotechnology, the research originated from the University of Sydney and Sydney Local Health District in collaboration with UiT. Years ago, they discovered the feasibility of delivering medications to the liver via nano-carriers, a method further developed in Australia and Europe.
While many medications can be orally consumed, insulin traditionally requires injection due to its breakdown in the stomach. McCourt elucidates the challenge of ensuring insulin reaches its intended destinations within the body. However, this hurdle has been surmounted by the researchers, who devised a protective coating for the insulin, safeguarding it from stomach acid and digestive enzymes until it reaches the liver, its targeted site of action.
Upon arrival in the liver, the coating disintegrates, triggered by enzymes activated during high blood sugar levels. Nicholas J. Hunt from the University of Sydney, leading the project with Victoria Cogger, highlights the controlled release mechanism of insulin, dependent on blood sugar levels. This approach mimics the natural insulin secretion process, offering a more patient-friendly alternative to injections, with reduced risk of hypoglycemia.
The innovative method mirrors how insulin functions in healthy individuals, primarily absorbed in the liver to regulate blood sugar levels. In contrast, injected insulin predominantly reaches muscles and adipose tissues, potentially causing fat accumulation and hypoglycemia. The new approach promises fewer adverse effects, eliminating the need for injections and enabling discreet administration, without the necessity for refrigeration.
The effectiveness of oral insulin has been validated through trials on nematodes, mice, rats, and recently, baboons. Incorporating it into sugar-free chocolate proved to be a palatable delivery method for the baboons, resulting in lowered blood sugar levels without adverse effects. While baboons without diabetes were involved in the study, mice and rats with diabetes showed promising outcomes without hypoglycemia or weight gain.
The next phase involves human trials scheduled to commence in 2025, led by Endo Axiom Pty Ltd., a spin-out company. These trials, spanning three phases, will assess safety and efficacy, with a particular focus on hypoglycemia incidence. Success in replicating the absence of hypoglycemia observed in baboons could signify a significant advancement.
Upon successful completion of phase I, which evaluates safety, phase II trials will explore the potential of oral insulin as a replacement for injections in diabetic patients. The researchers anticipate the new medicine could be available for widespread use within 2-3 years.