Insulins(Halozyme)

Companies like Dexcom and Insulet have been working to expand the reach of their devices from Type 1 diabetes into Type 2, which would include millions of people in the U.S. At the scientific sessions of the American Diabetes Association, multiple studies were presented showing benefits in Type 2 diabetes through a combination of continuous glucose monitoring and automated insulin pumps. These technologies have already made great strides in easing the daily burden of managing Type 1—by calculating insulin delivery and adjusting for changes in blood sugar levels—but expanding their reach into Type 2 would cover more than 90% of the nearly 40 million people in the U.S. living with diabetes. “By leveraging these innovations, we can empower patients with more effective and manageable treatment options, ultimately transforming the landscape of diabetes care,” Robert Gabbay, chief scientific and medical officer of the ADA, said in a statement during the association’s annual meeting in Orlando. First, a real-world analysis showed that the addition of CGM alone could help many patients keep their glucose more within a healthy range—including among three groups of people: those taking background or bolus insulins, and those using non-insulin therapies. The analysis of more than 7 million healthcare claims focused on about 6,000 people; each group saw their HbA1c levels improve by at least 1 percentage point within the year following their first CGM, after starting with an average baseline of 8.8%.  The same database also showed that the rate of both all-cause hospitalizations and acute diabetes-related hospitalizations were cut by more than half. “These results suggest that CGM can play a crucial role in enhancing health outcomes for all diabetes patients, regardless of their treatment regimen,” said the study’s lead author, Satish Garg, of the University of Colorado. “The real-world analysis underscores the potential of CGM to not only improve glycemic outcomes but also reduce healthcare resource utilization and overall healthcare costs.” Meanwhile, the wearable, tubeless insulin pump maker Insulet presented data from its Omnipod 5 system, showing that it could increase the amount of time spent in a healthy blood sugar range by 20%—while also lowering a person’s total daily dose of insulin by an average of about 23 units per day. The SECURE-T2D pivotal trial tracked a diverse group of over 300 adults with Type 2 diabetes who had been taking insulin for at least three months. After using the Omnipod 5 for 13 weeks, average HbA1c levels dropped from 8.2% to 7.4%. “A major strength of this study is the diversity of the enrolled population in terms of varying education level, income, ethnicity, and race,” said Insulet’s medical director, Trang Ly. “These results could have a particularly striking impact among Black and Hispanic people, who experience a higher prevalence of type 2 diabetes and increased mortality rates.” According to the company, the trial was the largest and most racially diverse to study automated insulin delivery systems among people with type 2 diabetes, including 24% Black and 22% Hispanic participants. In addition, 55% were on a stable regimen of GLP-1 medications. Currently, the Omnipod 5 is cleared in the U.S. for adults and children with Type 1 diabetes, and the company recently fully rolled out the system to the U.K. and the Netherlands. Insulet said it has already submitted the SECURE-T2D study data to the FDA in a bid to expand its use to people with Type 2 diabetes, with an eye on potential commercial launch early next year. Currently, there are no FDA-cleared automated insulin delivery systems for Type 2 diabetes. At the same time, a real-world study of Dexcom’s G6 and G7 wearable CGM sensors showed significant gains following six months of use—tracking more than 3,800 adults who were not taking insulin and had initially not been meeting their blood sugar targets. That included a 0.5 percentage point reduction in CGM approximations of A1c, and an additional four hours each day within a healthier glucose range. The study also showed that users who received automated hyperglycemia alerts saw the greatest improvements. Dexcom also presented a separate study showing its CGM could help guide behavior changes among people with prediabetes—including improvements in self-care related to eating, physical activity, weight and blood pressure, as well as in reported measurements of anxiety, energy levels and healthcare provider interactions. Also during the ADA meeting, Dexcom also announced that its G7 CGM sensor would now be compatible with Insulet’s Omnipod 5 tubeless pump. “As the evidence of the benefits of CGM use by people with Type 2 diabetes and prediabetes continues to grow, Dexcom is uniquely positioned to address their needs through our portfolio of products,” said Dexcom’s chief operating officer, Jake Leach, who also cited the company’s upcoming launch of its Stelo over-the-counter CGM set for this August. Stelo was cleared by the FDA this past March, allowing adults 18 years and older that are not taking any insulin therapies to purchase the system without a prescription—a population the company estimates includes about 25 million people with Type 2 diabetes. Dexcom has pitched the Stelo as a slimmed-down, “health-focused” version of its top-of-the-line G7, without the low blood sugar alerts or software features needed by people who use real-time blood sugar readings to calculate insulin doses.

Researchers have found a new way to supply the body with insulin. The medication that can be taken orally has already been tested on baboons, in which it was found to lower the blood sugar levels without causing hypoglycemia. The new insulin is ready to be tested on humans in 2025. If all goes well, diabetics are facing an easier life without injections. There are approximately 425 million people worldwide with diabetes. Approximately 75 million of these inject themselves with insulin daily. Now they may soon have a new alternative to syringes or insulin pumps. Scientists have found a new way to supply the body with smart insulin. The new insulin can be eaten by taking a capsule or even better, within a piece chocolate. Inside these we find tiny nano-carriers to which the insulin is encapsulated. The particles are 1/10,000th the width of a human hair and so small that you cannot even see them under a normal microscope. "This way of taking insulin is more precise because it delivers the insulin rapidly to the areas of the body that need it most. When you take insulin with a syringe, it is spread throughout the body where it can cause unwanted side effects," explains Professor Peter McCourt at UiT Norway's Arctic University. He is one of the researchers behind the study. The research was recently published in Nature Nanotechnology. Delivered to the liver It was researchers at the University of Sydney and Sydney Local Health District who, in collaboration with UiT, discovered many years ago that it was possible to deliver medicines via nano-carriers to the liver. The method has then been further developed in Australia and in Europe. Many medicines can be taken by mouth, but until now people have had to inject insulin into the body. McCourt explains that the problem with insulin with a nano-carrier is that it breaks down in the stomach and thus does not get to where it is needed in the body. This has been a major challenge for developing a diabetes medicine that can be taken orally. But now the researchers have solved this challenge. "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," says McCourt, who is a liver biologist. The coating is then broken down in the liver by enzymes that are active only when the blood sugar levels are high, releasing the insulin where it can then act in the liver, muscle, and fat to remove sugar from the blood. "This means that when blood sugar is high, there is a rapid release of insulin, and even more importantly, when blood sugar is low, no insulin is released," says Nicholas J. Hunt at the University of Sydney who, together with Victoria Cogger, leads the project. He explains that this is a more practical and patient-friendly method of managing diabetes because it greatly reduces the risk of a low blood sugar event occurring, namely hypoglycemia and allows for the controlled released of insulin depending on the patient's needs, unlike injections where all the insulin is released in one shot. Fewer side effects The new method works similarly to how insulin works in healthy people. The pancreas produces insulin which first passes through the liver where a large portion of it is absorbed and maintains stable blood sugar levels. In the new insulin method, the nano-carrier releases insulin in the liver, where it can be taken up or enter the blood to circulate in the body. "When you inject insulin under the skin with a syringe, far more of it goes to the muscles and to adipose tissues that would normally happen if it was released from the pancreas, which can lead to the accumulation of fats. It can also lead to hypoglycemia, which can potentially be dangerous for people with diabetes. With the new method, there will be fewer such side effects. In addition, you do not need to stab yourself with a needle and you can take the medicine you need in a slightly more discreet way. Also, this form of insulin does not need to be refrigerated. Tested on baboons The oral insulin has been tested on nematodes, on mice and rats. And lastly, the medicine has now been tested on baboons in the National Baboon Colony in Australia. "In order to make the oral insulin palatable we incorporated it into sugar-free chocolate, this approach was well received" says Hunt. He says that 20 baboons have taken part in this study. When they received the medicine, their blood sugar was lowered. The baboons were normal, healthy baboons, but the oral insulin have also been tested on mice and rats that actually have diabetes. The mice and rats did not have low blood sugar events (hypoglycemia), gain weight or fat accumulation in the liver overcoming current challenges with injectable and other oral insulins. What remains now is to test the new method on humans. Ready for use in 2-3 years "Trials on humans will start in 2025 led by the spin out company Endo Axiom Pty Ltd. Clinical trials are performed in 3 phases; in the phase I trial we will investigate the safety of the oral insulin and critically look at the incidence of hypoglycemia in healthy and type 1 diabetic patients. Our team is very excited to see if we can reproduce 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 physicians to ensure that they are safe for the test subjects" says 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," says the researcher. The researchers hope that the new medicine can be ready for use by everyone in 2-3 years.