Daily, Long-acting Oral Insulin Tablet Provides Comparable Glycemic Control To Insulin Glargine Injection In Patients With Type 2 Diabetes
Daily, Long-Acting Oral Insulin Tablet Provides Comparable Glycemic Control to Insulin Glargine Injection in Patients with Type 2 Diabetes A long-acting, oral insulin tablet has been found to safely improve glycemic control as effectively as the common, injected insulin glargine in people with Type 2 diabetes, according to the study, Efficacy and Safety of Oral Basal Insulin: Eight-Week Feasibility Study in People with Type 2 Diabetes (T2DM), presented today at the American Diabetes Associations 77th Scientific Sessions at the San Diego Convention Center. Safe and effective oral insulin has been a long-sought after treatment option in diabetes research. As an alternative to routine insulin injections, an easy-to-take oral insulin tablet has the potential to increase patients medication compliance and may facilitate earlier initiation of insulin therapy. The study evaluated the effectiveness and safety of OI338GT, an oral insulin tablet, by comparing it to injectable insulin glargine. The study included 50 patients with type 2 diabetes, average age of 61 years and who had never taken any type of insulin. The patients had A1C levels ranging from 7 to 10 percent, while on metformin alone or in combination with other oral diabetes medications. The patients were randomized 1:1 to receive a once daily treatment tablet of OI338GT, or an injection of insulin, glargine U100 (IGlar), once daily for a period of eight weeks. The trial was fashioned as a double-blind, double-dummy study, meaning that all patients received one injection and one tablet a day, only one of which contained insulin. To enable participants to achieve a fasting plasma glucose in the target range of 80-126 mg/dL, doses of both insulins were gradually increased once weekly on an individualized basis until no Continue reading >>
Daily, Long-acting Oral Insulin Tablet Provides Comparable Glycemic Control To Insulin Glargine Injection In Patients With Type 2 Diabetes
SAN DIEGO , June 13, 2017 /PRNewswire-USNewswire/ -- A long-acting, oral insulin tablet has been found to safely improve glycemic control as effectively as the common, injected insulin glargine in people with Type 2 diabetes, according to the study, "Efficacy and Safety of Oral Basal Insulin: Eight-Week Feasibility Study in People with Type 2 Diabetes (T2DM)," presented today at the American Diabetes Association's 77th Scientific Sessions® at the San Diego Convention Center. Safe and effective oral insulin has been a long-sought after treatment option in diabetes research. As an alternative to routine insulin injections, an easy-to-take oral insulin tablet has the potential to increase patients' medication compliance and may facilitate earlier initiation of insulin therapy. The study evaluated the effectiveness and safety of OI338GT, an oral insulin tablet, by comparing it to injectable insulin glargine. The study included 50 patients with type 2 diabetes, average age of 61 years and who had never taken any type of insulin. The patients had A1C levels ranging from 7 to 10 percent, while on metformin alone or in combination with other oral diabetes medications. The patients were randomized 1:1 to receive a once daily treatment tablet of OI338GT, or an injection of insulin, glargine U100 (IGlar), once daily for a period of eight weeks. The trial was fashioned as a "double-blind, double-dummy" study, meaning that all patients received one injection and one tablet a day, only one of which contained insulin. To enable participants to achieve a fasting plasma glucose in the target range of 80-126 mg/dL, doses of both insulins were gradually increased once weekly on an individualized basis until no additional therapeutic benefit was seen. The results showed that both the oral Continue reading >>
Why Is Insulin Injected Instead Of Taken By Mouth?
Insulin cannot be taken orally because it would break down in the digestive process. Insulin is a poly-peptide protein, which can be broken down by enzymes in the digestive system. By the time it reaches the small intestine, where it is absorbed, it is only a single peptide and can no longer function as insulin. Besides the chemical reasons for not ingesting insulin, there are other reasons that have more to do with the management of diabetes. Why Injection Is Better Blood sugar levels are subject to great change throughout the day. What foods were consumed, exercise, stress, illness, even time of day – all of these impact glucose levels. If this were not so, there would be no need to monitor levels with a finger prick multiple times each day. Insulin is needed to ensure that glucose is properly utilized and that levels of glucose remain stable. In order to work properly, insulin must enter the bloodstream intact. By injecting it into the subcutaneous tissue in our bodies, it is designed to be absorbed into the bloodstream without changing its properties and within a proscribed amount of time. Insulin should not be injected directly into muscle or into the bloodstream, as both will increase the speed of absorption. How fast absorption happens is also a function of what type of insulin is being used: rapid-acting, short-acting, intermediate-acting, long-acting or a mix of some of these. Each is designed to be absorbed and active over certain time frames, in order to cope with different glucose control needs, like consuming a meal or sleeping all night. Possible New Alternatives There is active research to develop alternatives to injections. One of the most promising is inhaled insulin. There was an inhaled insulin product, Exubera, on the market for about a year betwee Continue reading >>
Tweet Oral insulin is a reality: it is simply a matter of when. The realisation that insulin injections are going to have to become a part of everyday life can be extremely harrowing for many diabetics. Injection takes time, interrupts daily schedules and is considered unpleasant by many people. Children or adolescents who require daily insulin injections may find that the regimen impacts on their daily lifestyle to an even greater degree. Using insulin therapeutically is not a new practice at all, but delivery methods to make the process more bearable have not gained widespread prominence as of yet. Obviously, the priority in delivering insulin to a patient is to make sure it reaches the bloodstream intact. Alternative insulin delivery methods Many alternative delivery systems, although they work to some extent, leave the insulin broken down by digestive juices, usually too much for it to be of significant use to the body. Furthermore, the complicated environment within the stomach means that simple tablets would be unpredictable and ineffective. The solution will come, and may have already, when a pharmaceutical research company creates a tablet in which insulin can be enclosed and yet still pass through the stomach wall. Nose, mouth and lungs Three principal target areas are obvious in developing alternative insulin delivery systems: Nose Mouth Lungs Nasal delivery issues Nasal delivery into the upper airway presents severe problems, primarily that the transport system is too convoluted and would require massive, expensive quantities of insulin to reach the target area. Insulin delivery via the lungs Insulin into the lungs is a promising area: the insulin can be directly absorbed into the bloodstream through the thin walls of the lung. Insulin via the mouth Effective Continue reading >>
Could Oral Insulin Be An Option Some Day?
Type 1 diabetes and many cases of type 2 diabetes are treated with insulin injections. For decades, these injections have been the only way to deliver insulin. You might wonder, why hasn’t an easier way to give insulin been developed? The truth is, for more than 80 years, people have been trying to develop a form of insulin you can swallow. Pharmaceutical companies, government agencies, and universities have done extensive research in hopes of developing this “holy grail” of diabetes treatment. Where do we stand in the process? If you have any type of diabetes, keeping your blood sugar levels within your target range is vital. Not doing so raises your risk of serious health problems such as blindness, heart disease, kidney disease, and nerve damage. To keep your blood sugar levels in a safe range, you have to follow your diabetes treatment plan. For many people with diabetes, this involves insulin injections. These injections can be inconvenient, they require training to self-administer, and they may need to be given several times per day. And, of course, they involve needles, which many people don’t like. For all of these reasons, many people don’t follow their diabetes treatment plan, which can lead to severe complications. So, the idea that you could get your dose of insulin by simply swallowing a pill appeals to many people. Doctors believe that the ease of using a pill could make more people willing to start and maintain a successful insulin therapy routine. That could lead to better control of their diabetes. With injectable insulin, you use a needle to inject the insulin into the fatty tissue beneath your skin. From there, the insulin travels to your bloodstream. It goes into general circulation throughout your body and then travels to your liver. Oral Continue reading >>
Oral Insulin Reloaded
Go to: Abstract Optimal coverage of insulin needs is the paramount aim of insulin replacement therapy in patients with diabetes mellitus. To apply insulin without breaking the skin barrier by a needle and/or to allow a more physiological provision of insulin are the main reasons triggering the continuous search for alternative routes of insulin administration. Despite numerous attempts over the past 9 decades to develop an insulin pill, no insulin for oral dosing is commercially available. By way of a structured approach, we aim to provide a systematic update on the most recent developments toward an orally available insulin formulation with a clear focus on data from clinical-experimental and clinical studies. Thirteen companies that claim to be working on oral insulin formulations were identified. However, only 6 of these companies published new clinical trial results within the past 5 years. Interestingly, these clinical data reports make up a mere 4% of the considerably high total number of publications on the development of oral insulin formulations within this time period. While this picture clearly reflects the rising research interest in orally bioavailable insulin formulations, it also highlights the fact that the lion’s share of research efforts is still allocated to the preclinical stages. Keywords: diabetes, oral insulin, glycemic control, bioavailability, oral delivery, enteral absorption After more than 90 years of oral insulin research, commercial availability of an insulin product for oral use still seems to be a distant prospect. The quest for an oral insulin therapy started in the early twenties of the past century, almost immediately after the discovery of insulin and initiation of insulin injection therapy. Already the first pilot experiments perfo Continue reading >>
Oral Insulin Proving Successful In Human Clinical Trials
Oral insulin proving successful in human clinical trials Insulin in a pill is one step closer to reality as clinical trials progress(Credit: SergIllin/Depositphotos ) For decades researchers have worked to find a way to orally administer insulin effectively to patients with diabetes. Now this game-changing treatment is one step closer to reality, with pharmaceutical company Oramed embarking on a final Phase 2b human clinical trial to prove the efficacy of its oral insulin before moving to the final stages of trials and registrations that could bring the treatment to market within a few short years. Oral insulin has long been considered the holy grail of diabetes treatment with many scientists trying, and failing, to produce an effective drug. The big challenge is that the acidity of the stomach degrades the protein before it can pass through into the intestine for absorption. The big development from Oramed was in creating not only a pH sensitive capsule coating that protects the drug until it reaches the small intestine, but to also enhance the ability of the insulin to permeate the intestinal membrane and better cross into the bloodstream. This oral insulin formation has successfully moved through Phase 1 safety trials and several Phase 2 trials, demonstrating a statistically significant blood glucose lowering efficacy. This new trial is set to examine the drug's impact over 90 days, after earlier trials only studied the efficacy over 28 days. "This is our most important study to date," says Oramed CEO Nadav Kidron. "A year from now we will better know the potential of our drug to control and maintain blood glucose levels and will have further proof of the longer-term benefits of taking an oral pill versus an injection." Delivering insulin in a pill form would undoub Continue reading >>
Glucose Control With Oral Insulin Tablet Similar To Injection In Study
Glucose Control with Oral Insulin Tablet Similar to Injection in Study Fasting plasma glucose in the pill group fell from 175mg/dL at baseline to 129mg/dL by end of treatment This article is part of MPR's coverage of the American Diabetes Association's 77th Scientific Sessions (ADA 2017) , taking place in San Diego, CA. Our staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back regularly for more news from ADA 2017 . A long-acting oral insulin tablet was found to be as effective as insulin glargine injection in a study involving 50 patients with type 2 diabetes, according to a double-blind, double-dummy feasibility study presented at the American Diabetes Association 77th Scientific Sessions in San Diego, CA. The tablet, OI388GT (Oral insulin 338 formulated into a GIPETI tablet), is a basal, acylated insulin analog with a half-life of ~70 hours. Study patients (average age 61) were insulin-naive and had A1C levels ranging from 710% while taking metformin alone or with other oral antidiabetics. They were randomized 1:1 to receive OI388GT or insulin glargine U100 once daily for 8 weeks. Both oral and injectable insulin substantially improved fasting plasma glucose (primary endpoint), HbA1c, and fructosamine with no differences between groups. Fasting plasma glucose in the OI338GT group fell from 175mg/dL at baseline to 129mg/dL by end of treatment. In the insulin glargine group, fasting plasma glucose fell from 164mg/dL at baseline to 121mg/dL by end of treatment (difference 5.2 95% CI: -8.8, 19.1;P=0.4567). Regarding A1c levels, there was a decrease from 8.1 at baseline to 7.3 after treatment in the OI338GT group.For the insulin glargine group, the average A1C dropped from 8.2 at Continue reading >>
Oral Insulin Delivery: How Far Are We?
Go to: Abstract Oral delivery of insulin may significantly improve the quality of life of diabetes patients who routinely receive insulin by the subcutaneous route. In fact, compared with this administration route, oral delivery of insulin in diabetes treatment offers many advantages: higher patient compliance, rapid hepatic insulinization, and avoidance of peripheral hyperinsulinemia and other adverse effects such as possible hypoglycemia and weight gain. However, the oral delivery of insulin remains a challenge because its oral absorption is limited. The main barriers faced by insulin in the gastrointestinal tract are degradation by proteolytic enzymes and lack of transport across the intestinal epithelium. Several strategies to deliver insulin orally have been proposed, but without much clinical or commercial success. Protein encapsulation into nanoparticles is regarded as a promising alternative to administer insulin orally because they have the ability to promote insulin paracellular or transcellular transport across the intestinal mucosa. In this review, different delivery systems intended to increase the oral bioavailability of insulin will be discussed, with a special focus on nanoparticulate carrier systems, as well as the efforts that pharmaceutical companies are making to bring to the market the first oral delivery system of insulin. The toxicological and safety data of delivery systems, the clinical value and progress of oral insulin delivery, and the future prospects in this research field will be also scrutinized. Keywords: clinical trials, diabetes, hypoglycemic effect, insulin, nanoparticles, oral delivery system Continue reading >>
Insulin Pills And Tablets
Tweet Insulin pills, also known as insulin tablets, remain at an early stage of clinical trials with several companies racing to establish this as a credible alternative to insulin injections. Giving diabetes patients the chance to avoid the pain of needles has been the goal of many pharmaceutical companies for many years. However, a drugmaker has yet to success in encapsulating insulin into a one-off dose, easily swallowed like any other tablet. Difficult to ingest Insulin is a particularly difficult drug to ingest orally. It is a protein that degrades in the stomach and small intestine, making it almost impossible to design oral delivery which works. The past has seen massive oral insulin efforts flop, including the inhalable insulin Exubera. However, major drugmakers are thought to be working on the insulin pill, Novo Nordisk amongst them. Direct to the liver The theory is ideal for people with diabetes. Insulin delivery via the stomach would transport the much needed hormone directly to the liver, where it could mimic the action of endogenous insulin. In fact, the future could see insulin pills making diabetes management considerably more safe and convenient, not to mention eliminating prevalent needle phobia. At this stage, insulin remains too complex a protein to survive within the environment of the body. Leading pharmaceutical companies are thought to be using protein engineering to bring the insulin pull one step closer. The researchers are thought to be indentifying which enzymes attack the molecule, and what processes they use. In theory the insulin pill will one day be able to navigate the stomach without being broken down. Tweet Type 2 diabetes mellitus is a metabolic disorder that results in hyperglycemia (high blood glucose levels) due to the body: Being Continue reading >>
12 Myths About Insulin And Type 2 Diabetes
Insulin facts vs. fiction When you hear the word “insulin,” do you picture giant needles (ouch!) or pop culture portrayals of insulin users with low blood sugar (like Julia Roberts losing it in Steel Magnolias)? Either way, most people think of insulin as a difficult, painful, or potentially scary medical treatment. The problem is that if you have type 2 diabetes, you need to know the real deal before you can make an informed choice about whether or not this potentially lifesaving therapy is right for you. Here, we take a look at the facts and fiction about insulin when it comes to treating type 2 diabetes. Diabetics always need insulin Not necessarily. People with type 1 diabetes (about 5% to 10% of diabetics) do need insulin. If you have type 2, which includes 90% to 95% of all people with diabetes, you may not need insulin. Of adults with diabetes, only 14% use insulin, 13% use insulin and oral medication, 57% take oral medication only, and 16% control blood sugar with diet and exercise alone, according to the CDC. The point is to get blood sugar—which can be a highly toxic poison in the body—into the safe zone by any means necessary. Taking insulin means you’ve ‘failed’ “This is a big myth,” says Jill Crandall, MD, professor of clinical medicine and director of the diabetes clinical trial unit at the Albert Einstein College of Medicine, in the Bronx, N.Y. “Many people who try very hard to adhere to a diet, exercise, and lose weight will still need insulin.” The fact is that type 2 diabetes is a progressive illness, meaning that over time you may need to change what you do to make sure your blood sugar is in a healthy range. Eating right and exercise will always be important, but medication needs can vary. “A large percentage of people with ty Continue reading >>
Diabetes Medication Misconceptions
If you or a loved one has recently been diagnosed with type 1 or type 2 diabetes, you may have some questions about how the diseases are treated. There are many misconceptions about diabetes medications, mainly because the treatment for type 1 and type 2 diabetes can be very different. One of the most pervasive myths about diabetes--both forms of it--is that the disease can be treated by simply refining your diet or exercising more. While this is certainly an option for some people with type 2 diabetes, it is absolutely untrue for people with type 1. Type 1 diabetes is an auto-immune disease that occurs when the body’s disease fighting system, the immune system, destroys all your body's insulin-producing cells. Insulin is a vital agent that your body needs to convert food into energy. If your body is not producing insulin, you must take it by injection or a pump to live. Insulin currently cannot be taken by mouth because the digestive juices in your stomach and intestine will break down the insulin before it has a chance to get into your bloodstream to do its job. If you have type 2 diabetes, you may or may not have to take insulin injections, depending on a variety of factors. Contrary to popular belief, insulin injections are not for people with diabetes who have been "bad"—instead, taking insulin is a reflection of insulin production by the pancreas. People diagnosed with type 2 diabetes in general are still producing some insulin, although the amount they produce is not enough for their needs. Their cells may also be resistant to the effects of insulin, which makes them require more insulin than a person who does not have diabetes. Frequently when type 2 diabetes is diagnosed, weight loss, exercise, and changes in how much you eat can bring blood glucose levels Continue reading >>
Oral Insulin Could Still Be A Reality, Says Novo Nordisk
Last October Novo Nordisk announced that it had shelved plans to bring the world’s first oral insulin to market . But the company has just presented early stage data showing the formulation to be as effective as injectable insulin – and says a future advance in drug delivery could still make it a reality. An oral version of insulin would be an enormous breakthrough in treating type 1 and type 2 diabetes patients, as freedom from daily injections would liberate patients, and help boost compliance and allow earlier uptake. Novo yesterday presented preliminary data which showed the formulation, O1338GT, is as effective as Sanofi’s insulin injectable Lantus in controlling blood glucose levels. But the Denmark-headquartered diabetes specialist company says the economics of bringing an oral version to market don’t stack up, and won’t be advancing the drug for the foreseeable future. That’s because the level of investment needed to make the oral version a feasible alternative to injections would mean a premium price – and US payers have recently turned against high price insulins. Pharmacy benefit managers (PBMs) in the US forced companies in the diabetes market to lower prices last year, changing the dynamics in the market overnight, and forcing Novo to re-think plans for its oral candidate. Nevertheless, the company yesterday presented an eight-week feasibility study in 50 people with Type 2 diabetes was presented at the American Diabetes Association’s congress in San Diego. The results showed that both the oral insulin tablet and injectable Lantus substantially improved blood glucose levels and other efficacy parameters, with no significant differences between the two insulins at eight weeks “The results of our feasibility study show for the first time tha Continue reading >>
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Oral Insulin: The Rationale For This Approach And Current Developments
Go to: Abstract Insulin remains the most effective and durable hypoglycemic agent for the treatment of diabetes. The addition of an effective oral insulin dosage form to the antidiabetes armamentarium may have significant benefits in terms of fostering compliance and adherence among patients, as well as physiologic advantages due to the fact that such a dosage form replicates the natural route of insulin secretion and absorption through the portal vein and targets the liver directly. Several companies have developed technological platforms that protect polypeptides and proteins from enzymatic hydrolysis, enable their transport across the epithelial lining, and promote their absorption from the gastrointestinal tract. A review of the potential physiological rationale and advantages, as well as of current pertinent technologies used specifically with insulin, is herewith provided. Keywords: diabetes, glucose metabolism, insulin, liver, oral antidiabetic medication, portal vein Go to: Introduction The introduction of insulin therapy was hailed as one of the therapeutic miracles of modern times, saving lives and preserving the health of millions of people worldwide. In the years since insulin was introduced, research on many fronts has resulted in significant developments in production, purification, and pharmaceutical formulation and in refinements in devices for parenteral insulin administration. Despite these advances, realizing the dream of administering insulin orally, and hence replicating physiological patterns of insulin secretion with the accompanying advantages, remains an elusive goal. Recent advances in science and technology have brought about methods to (1) overcome the barriers to absorption presented in the gastrointestinal tract and (2) protect the insulin Continue reading >>
The Pursuit Of Oral Insulin
Its been 12 months since Novo Nordisk made the difficult decision to discontinue its oral insulin development programme. Here, Chief Science Officer Mads Krogsgaard Thomsen reflects on a year of learning, on what motivates him and his team and on the possibility to one day revisit the potential of oral insulin. By Mads Krogsgaard Thomsen,Chief Science Officerof Novo Nordisk | Published 10 November 2017 The story of oral insulin is closely linked with the discovery of the hormone itself a century ago as well as Novo Nordisks own history. In fact, when the co-discoverer of the molecule Frederick Banting first gave insulin to a person with diabetes in 1921, it was administered orally though sadly without success. And, ever since I joined Novo Nordisk more than 25 years ago, oral insulin has been the Holy Grail; a breakthrough that we know could help many people living with diabetes. That is why the past year has been one of mixed emotions for me as chief science officer. From a scientific point of view, I am extremely proud of how far we have come in developing oral insulin, and I am grateful to the colleagues who worked so hard to achieve this. Our scientists were the first to show that it is possible to deliver basal insulin in a once-daily tablet form. Weve created the molecule that can survive the tough environment of the gastro-intestinal tract before being absorbed and lowering blood glucose levels as a modern, injectable basal insulin would. In scientific terms, this is a tremendous step forward of which I am extremely proud. But scientific achievements do not always result in medicines in the hands of patients and, in this case, science alone was not enough. This is deeply frustrating for both people with diabetes and for Novo Nordisk. Because when patients hear a Continue reading >>