There are around 425 million diabetics worldwide. Every day, over 75 million of these individuals inject themselves with insulin. They may soon have a new option for syringes and insulin pumps. Scientists have discovered a new approach to provide the body with smart insulin.
The new insulin may be consumed by swallowing a capsule or, better yet, by eating a piece of chocolate.
These contain microscopic nano-carriers that encapsulate the insulin. The particles are 1/10,000th the width of a human hair and so minuscule that they cannot be seen with a standard microscope.
“This method of administering insulin is more exact because it distributes insulin quickly to the parts of the body that require it the most. “When you take insulin with a syringe, it spreads throughout the body and can cause unwanted side effects,” explains Professor Peter McCourt of UiT Norway’s Arctic University. He is one of the researchers responsible for the study.
The findings were just reported in Nature Nanotechnology.
Delivered to the liver
Researchers at the University of Sydney and Sydney Local Health District discovered many years ago, in partnership with UiT, that medications may be delivered to the liver using nano-carriers. The approach was then further improved in Australia and Europe.
Many medications can be taken orally, but insulin has traditionally been administered by injection. McCourt adds that the difficulty with insulin with a nano-carrier is that it breaks down in the stomach and hence does not reach the body’s required locations. This has proven to be a significant obstacle in designing an oral diabetic medication.
However, the researchers have now overcome this difficulty.
“We have created a coating to protect the 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,” explains McCourt, who works as a liver biologist.
The coating is subsequently broken down in the liver by enzymes that are only activated when blood sugar levels are high, releasing insulin, which may then operate in the liver, muscle, and fat to remove sugar from the blood.
“This means that when blood sugar is high, insulin is released quickly, and even more importantly when blood sugar is low, no insulin is released,” explains Nicholas J. Hunt of the University of Sydney, who is leading the experiment alongside Victoria Cogger.
He explains that this is a more practical and patient-friendly method of managing diabetes because it reduces the risk of a low blood sugar event, specifically hypoglycemia, and allows for the controlled release of insulin based on the patient’s needs, as opposed to injections, which release all of the insulin in one shot.
Fewer Side Effects
The new approach functions similarly to how insulin works in healthy humans. The pancreas creates insulin, which initially travels via the liver, where a major part is absorbed and blood sugar levels remain steady. In the novel insulin technique, the nano-carrier delivers insulin into the liver, where it can be absorbed or enter the bloodstream and circulate throughout the body.
“When insulin is injected under the skin using a syringe, significantly more of it is sent to the muscles and adipose tissues than if it were released from the pancreas, which can contribute to fat storage. It can also cause hypoglycemia, which is potentially harmful for diabetics.
The new procedure will result in fewer adverse effects.
Furthermore, you do not need to hurt yourself with a needle, and you may take the medicine you require in a somewhat more subtle manner. Also, this kind of insulin does not require refrigeration.
Tested on Baboons
Oral insulin was studied in worms, mice, and rats. Finally, the drug has been tried on baboons at the National Baboon Colony in Australia.
“To make the oral insulin palatable, we incorporated it into sugar-free chocolate; this approach was well received,” Hunt explains.
He claims that 20 baboons took part in this investigation. When they received the medication, their blood sugar levels dropped.
Although the baboons were typical, healthy baboons, oral insulin was also tried on diabetic mice and rats. The mice and rats did not have low blood sugar (hypoglycemia), weight gain, or fat deposition in the liver, surpassing current limitations with injectables and other oral insulins.
All that remains is to test the new approach on humans.
Ready to Use in 2-3 Years
“Trials on people will begin in 2025, lead by the spin-out firm Endo Axiom Pty Ltd. Clinical studies are conducted in three phases; in phase I, we will explore the safety of oral insulin and critically examine the prevalence of hypoglycemia in healthy and type 1 diabetic patients.”
“Our team is quite enthusiastic to see if we can replicate the missing hypoglycemia outcomes reported in baboons in humans since this would be a significant step forward. The tests must adhere to high-quality standards and be carried out in partnership with physicians to assure the safety of the test participants,” adds Hunt.
“After this phase I we will know that it is safe for humans and will investigate how it can replace injections for diabetic patients in phase 2 trials,” the author of the study adds.
The researchers expect that the new treatment will be available to everyone within two to three years.