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Insulin pills, an easier-to-swallow alternative to daily injections, are now in clinical testing and could one day transform the treatment of type 2 diabetes. MONDAY, April 15, 2013 — Insulin in pill form could improve the quality of life for millions of people struggling to control their diabetes, and two drugmakers have recently made developments that bring this long-sought treatment a few steps closer to reality. Last week, Israeli-based Oramed Pharmaceuticals announced it had submitted an Investigational New Drug (IND) application for its oral insulin drug to the Food and Drug Administration (FDA) with the goal of conducting a phase 2 clinical trial in the United States. In addition, Danish drugmaker Novo Nordisk, the world’s biggest insulin producer, successfully completed a phase 1 trial with its version of an insulin capsule last month. The investigational drugs from both Oramed and Novo Nordisk specifically target people with type 2 diabetes, who usually make some insulin when they are diagnosed but produce less and less of the hormone as the disease worsens.
Physicians, particularly time-challenged primary care providers, may be hesitant to start people with type 2 diabetes on insulin injections because it requires a fair amount of patient education, said Dr. In addition to ease of use, an insulin pill may offer a biological advantage over injections, said Miriam Kidron, PhD, Chief Scientific Officer and founder of Oramed. The investigational drugs from Novo Nordisk and Oramed are intended to be once-daily medications that lower blood sugar for a period of hours or up to a day, similar to long-acting insulins currently available as injections.
Neither of the tablets would supply a precise enough dose to replace injections for people with type 1 diabetes, who produce no insulin and must tightly regulate their insulin needs and blood sugar levels to avoid life-threatening consequences.
Many consider oral insulin the “holy grail” of diabetes treatment, and scientists have been chasing this elusive goal for nearly a century.
Scientists are now well aware that insulin’s size and structure makes it impossible to deliver in pill form without special protections or modifications. Even if insulin does survive digestion, the big, bulky protein has to make it across the intestinal lining, which is designed to absorb much smaller compounds. However, the creation of an effective insulin pill is far more feasible today than it was even 10 years ago, thanks to significant advances in drug delivery technology and molecular techniques. To outsmart the body’s digestive system, Oramed created a specially-coated capsule that packages insulin with several helper compounds to block protein-degrading enzymes and enhance insulin’s absorption into the blood. Scientists at Novo Nordisk are using a different approach — they tinkered with the structure of the insulin protein to make it more resistant to breakdown in the gut.
Novo Nordisk has spent $500 million over the last 5 years developing oral formulations of insulin and another injectable diabetes medication, GLP-1.
Oramed has already put their investigational drug through several small phase 2 trials, including a 2010, six-week study in 29 patients with type 2 diabetes in South Africa. Both Oramed and Novo Nordisk are still early in testing process and years away from bringing a drug to market, even if all goes well in future clinical trials.
And there’s no guarantee that either firm’s formulation will be a success, as evidenced by the disappointing results in late-stage testing of another insulin pill, developed by Indian biotechnology company Biocon.

Drugmakers’ attempts to offer patients other unique, non-injectable forms of insulin haven’t been successful, either.
For now, experts outside of pharma remain cautiously optimistic about the future of oral insulin medications.
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If you have diabetes or know someone who does, you may be especially interested in doing a science project that explores a specific angle of diabetes. Use a model to investigate how a person's genetics affect their chances of getting Type 1 Diabetes.
Investigate how blood glucose levels change with exercise and how the effect may vary person to person.
Build a model of an artificial pancreas and explore the challenges involved in this kind of system.
Use jello shapes to model insulin and explore why some medicines work in pill form and others do not. You may print and distribute up to 200 copies of this document annually, at no charge, for personal and classroom educational use. Reproduction of material from this website without written permission is strictly prohibited. An insulin tablet would be a more convenient and palatable treatment option for people with diabetes, according to many experts, and a handful of pharmaceutical companies are competing to be the first to bring this medical innovation to the market. This early-stage study, conducted in Germany, tested a single dose of the drug in less than 100 people.
Supplementing the body’s natural insulin supply with insulin medications can improve blood sugar control and slow the progression of diabetes, but patients are often reluctant to begin taking injections. After the insulin is absorbed from a capsule, it travels to the liver, which then directs distribution of the hormone throughout the body. Elliott Joslin, MD, one of the world’s earliest diabetes specialists, first tested oral insulin on humans without success in 1922, the year after insulin was discovered. Most drugs available as capsules and tablets are small chemical compounds, but insulin is a large protein, and in order for that protein to survive the long journey from the mouth to the blood supply, it has to clear a series of difficult biological hurdles. Just like the protein in a juicy steak, the digestive system is programmed to attack the insulin protein and break it down into its basic building blocks. The company also partnered with Merrion Pharmaceuticals, a Dublin, Ireland-based specialty pharmaceutical firm that has designed a patented system to make complicated drugs more absorbable. The drugmaker is currently testing a few different forms of its insulin drug and drug delivery system in phase 1 clinical trials and does not have a timeline set for advancing to later-stage trials.

The trial found that the formulation was well-tolerated, did not have serious side effects, and showed preliminary evidence of effectiveness.
In 2011, Biocon announced that its oral insulin drug failed to meet treatment goals for lowering blood sugar in a multi-center clinical trial conducted in India.
Pfizer’s novel insulin inhaler Exubera, which allowed people breathe the hormone in through their lungs, gained FDA approval in 2006, but was a notorious flop. View all.ConnectDon't miss out on breaking news, live chats, lively debates, and inspiring stories. This can be somewhat painful and inconvenient, but Swiss drugmakers Novartis are currently exploring the idea of using robotic pills to deliver the doses of insulin, according to a report from Reuters.Teaming up with Rani Therapeutics, the pill is dubbed the Rani capsule, the idea behind it is rather straightforward.
From the data you may be collecting with your continuous glucose monitor and carb counting to the ways in which factors like exercise affect blood glucose to technology and engineering related to diabetes tools and devices, there are all kinds of exciting projects you can explore. Doctors may be more likely to prescribe an insulin pill earlier in a patient’s treatment course, which could reduce the risk for long-term complications. Unlike an injection directly into the blood supply, this process closely replicates the body’s natural circulation of insulin. The company filed its original IND application with the FDA in December, and last week submitted a revised application to meet the FDA’s request for a small sub-study before the agency considers approval for a phase 2 trial in the United States. The company subsequently partnered with Bristol-Meyers Squibb to further develop its oral formulation. Pfizer withdrew the product after only about a year on the market due to poor sales, a result of safety concerns and complicated dosing requirements. Join the conversation!Free NewslettersPersonalized tips and information to get and stay healthier every day. Some scientists theorize this delivery route may reduce the risk for hypoglycemia – low blood sugar – a common side effect of insulin injections, but drug companies have yet to confirm this with clinical studies. It’s actually a tiny robot that will be able to deliver the insulin through tiny needles that are made of sugar which are then pushed through the wall of the intestine.According to the company, it seems that the robotic pill will be able to do more than just deliver insulin into the system.
They are hoping that the pill can also be used with other forms of medication that require injections as well, such as treatments for rheumatoid arthritis, psoriasis, and multiple sclerosis.At the moment the company is looking to conduct feasibility studies over the next 18-24 months to evaluate what other biologic medicines can be delivered into the bloodstream in a similar manner. It is unclear as to when diabetes patients can look forward to these robotic pills, but it sounds like an interesting advancement in the medical field.Filed in Medical >Robots.

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