Oral Insulin to Undergo Human Trials in 2025

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Oral Insulin to Undergo Human Trials in 2025: Potential Market Launch in 2-3 Years

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Oral Insulin to Undergo Human Trials in 2025: Potential Market Launch in 2-3 Years

Researchers have successfully developed an oral insulin that has proven to effectively lower blood sugar and prevent hypoglycemia in mice, rats, and baboons.

The hope is that this medication will be available for widespread use in a few years.

The substantial investment by scientists and researchers in developing oral insulin is understandable, given that, as of 2021, there were 537 million adults worldwide suffering from diabetes, with a projected increase to 643 million by 2030, equating to one in every ten individuals. Unfortunately, despite scientists’ best efforts, oral insulin is not yet available on the market.

Now, researchers from the UiT The Arctic University in Norway, in collaboration with the University of Sydney, have developed an oral insulin that has demonstrated efficacy in animal models and is set to enter human clinical trials in 2025.

Peter McCourt, one of the co-authors of the study, explained, “This method of insulin delivery is more precise, as it rapidly delivers insulin to the body’s most needed areas. When insulin is injected using a syringe, it spreads throughout the body, potentially causing unnecessary side effects.”

Diabetic patients currently rely on injected insulin or insulin pumps for strict blood sugar control, reducing the risk of long-term complications such as cardiovascular diseases or kidney, nerve, and eye disorders. However, they also need to monitor acute adverse reactions such as high and low blood sugar, both of which can pose serious health risks.

Previous findings by researchers indicated that using nano-carriers could transport drugs to the liver, where the majority of insulin secreted by the pancreas acts in a healthy body. However, the delivery system must withstand the harsh conditions of high acidity and enzyme action in the stomach, which can render the drug ineffective.

McCourt stated, “We created a coating to protect insulin from being broken down by stomach acid and enzymes during its journey through the digestive system, keeping it stable until it reaches its destination, the liver.”

Researchers applied a pH and enzyme-sensitive coating (a chitosan and glucose copolymer) to insulin combined with silver sulfide (Ag2S) quantum dots. This coating breaks down in the liver due to enzymes, which are activated only when blood sugar is high, releasing insulin and promoting the storage of glucose in the liver, muscles, and fat for use as an energy source, removing it from the bloodstream.

The first author and co-corresponding author, Nicholas Hunt, emphasized, “This means that insulin is rapidly released when blood sugar is high, and more importantly, it does not release when blood sugar is low.”

The researchers initially tested their novel oral insulin on nematodes (Caenorhabditis elegans), mice, and rats, followed by testing on baboons.

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

The researchers administered oral insulin to 20 healthy non-diabetic baboons. Oral insulin at doses of 5 international units/kg and 10 international units/kg reduced blood sugar by 10% and 13%, respectively, with noticeable effects within 15 to 30 minutes. No baboons experienced hypoglycemia. Although baboons do not have diabetes, the researchers observed that diabetic mice and rats did not experience hypoglycemia after taking the medication.

Researchers claim that this medication functions more similarly to how insulin operates in a healthy human body and is more practical, convenient for patients – eliminating the need for injections, offering discretion, and not requiring refrigeration.

“When you inject insulin subcutaneously with a syringe, more insulin enters muscle and fat tissues. Typically, if insulin is released from the pancreas, it may lead to fat accumulation,” said Hunt. “It could also result in hypoglycemia, which can be dangerous for diabetes patients.”

The next step is for researchers to conduct human trials for their oral insulin. Hunt stated, “Human trials are set to begin in 2025, led by the spin-off company Endo Axiom Pty Ltd. The clinical trials will be conducted in three stages; in the first stage, we will investigate the safety of oral insulin and closely examine the occurrence of hypoglycemia in both healthy individuals and type 1 diabetes patients. The team is highly optimistic about replicating the baboon’s hypoglycemia-free results in humans, as it would mark a significant advancement. The experiments follow strict quality requirements, requiring collaboration with physicians to ensure the safety of the participants. After the first stage, we will know that it is safe for humans, and we will study how it can replace injection treatments for diabetes patients in the second stage.”

Researchers hope that their oral insulin will be available for use within two to three years.

This study was published in the journal “Nature Nanotechnology.”

Oral Insulin to Undergo Human Trials in 2025: Potential Market Launch in 2-3 Years

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