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Oral Insulin Novo Nordisk

Oral Insulin

Oral Insulin

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 >>

In Diabetes War, Novo Nordisk Aims To Break Mold With New Pill

In Diabetes War, Novo Nordisk Aims To Break Mold With New Pill

February 6, 2018 / 3:28 PM / 3 months ago In diabetes war, Novo Nordisk aims to break mold with new pill LONDON (Reuters) - After nearly a century building a company worth $125 billion based on injectable drugs, Denmarks Novo Nordisk ( NOVOb.CO ) - the worlds biggest insulin maker - wants to prove this year it can transform the diabetes market with a pill. FILE PHOTO: A view shows kettles at an insulin production line in Novo Nordisk's plant in Kalundborg, Denmark November 4, 2013. REUTERS/Fabian Bimmer/File Photo Novos oral semaglutide medicine is important for ensuring the groups long-term growth - a critical mission after 2017 results last week revealed mounting price pressure in a crowded market targeting the worlds 450 million diabetics. Rivals, especially Eli Lilly ( LLY.N ), are watching Novos final-stage oral semaglutide trials closely, ahead of the drugs potential 2020 launch. The once-daily pill belongs to a blockbuster class of treatments known as GLP-1s that stimulate insulin production, the first of which were derived from the venomous bite of North Americas Gila monster lizard. So far, all have been injections. While diabetics with advanced disease need daily insulin shots, those at a less serious stage start on simple tablets, with GLP-1s added as a potent new option since 2005. Today, GLP-1s are embraced as a highly effective diabetes therapy and semaglutide, which was approved as a once-weekly injection in December, has out-gunned rivals in efficacy. But the needle is still a barrier. There is resistance in some patients to move to an injectable medication, said Dr. Jason Gaglia, a diabetes expert at the Joslin Diabetes Center in Boston. Once an oral is available I think there will be significant interest in it. If the data stack up from 10 pivotal Pha Continue reading >>

Merrion, Novo Nordisk To Collaborate On Oral Insulin Analogues

Merrion, Novo Nordisk To Collaborate On Oral Insulin Analogues

Merrion, Novo Nordisk To Collaborate On Oral Insulin Analogues This article was originally published in The Pink Sheet Daily Despite giving up on inhaled insulin earlier this year, deal continues Novo Nordisks focus on enhancements to insulin formulation and delivery. Already Registered? Sign in to continue reading. Your username does not meet the requirements. Sorry - this email domain is not allowed. Sorry - public email accounts are not allowed. Please provide a work email address. An account with that username already exists. Unfortunately we've not been able to process your registration. Please contact support. Your question has been successfully sent to the email address below and we will get back as soon as possible. [email protected] Please make sure all fields are completed. Please make sure you have filled out all fields Please make sure you have filled out all fields All set! This article has been sent to [email protected] All fields are required. For multiple recipients, separate email addresses with a semicolon. Please make sure all fields are completed. Please make sure you have filled out all fields Please make sure you have filled out all fields Subject: Merrion, Novo Nordisk To Collaborate On Oral Insulin Analogues Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe. Finish creating your saved search alert after you sign in Continue reading >>

The Pursuit Of Oral Insulin

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 >>

Novo Nordisk To Transform Diabetes Market With New Pill

Novo Nordisk To Transform Diabetes Market With New Pill

Novo Nordisk to Transform Diabetes Market With New Pill Novo Nordisk is entering a critical first quarter of 2018 with its insulin pill. European drugmaker and the worlds biggest insulin maker, Novo Nordisk, wants to prove it can transformthe diabetes market with a pill. The once-daily pill is first of its kind and belongs to a blockbuster class of treatments known as GLP-1s that stimulate insulin production. The GLP-1 analoguemimics a hormone secreted in the intestine and has shown a number of benefits for blood sugar, weight and the cardiovascular system.So far, all GLP-1 treatments have been injections. GLP-1 has been embraced as a highly effective diabetes therapy for those at a less serious diabetic stage, since 2005. Semaglutide, which was approved as a once-weekly injection in December, has out-gunned rivals in efficacy, however, the needle is still a barrier. Once an oral is available I think there will be significant interest in it, Dr.Jason Gaglia, a diabetes expert at the Joslin Diabetes Center in Boston, told Reuters. Eli Lilly, one of the companys biggest rivals have been watchingNovos final stage trials closely, ahead of the drugs potential launch in 2020. The oral medicine market in diabetes has avalue of $28 billion, which means that the results from these clinical trials could open the doors for a new market worth up to $16 billion for Novo. A tablet option is something that would be preferable for patients, and one could get a higher price for that, CEO of Novo Nordisk, Lars Fruefaard Jrgensen told Danish newspaper, Brsen. Continue reading >>

Research Programme: Oral Insulin Analogues - Merrion/novo Nordisk

Research Programme: Oral Insulin Analogues - Merrion/novo Nordisk

Research programme: oral insulin analogues - Merrion/Novo Nordisk Research programme: oral insulin analogues - Merrion/Novo Nordisk * Final gross price and currency may vary according to local VAT and billing address. * Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase. A link to download a PDF version of the drug profile will be included in your email receipt. Adis is an information provider. We do not sell or distribute the pharmaceutical compounds written about in this database. Originator Merrion Pharmaceuticals; Novo Nordisk Mechanism of Action Insulin receptor agonists Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases. No development reported Diabetes mellitus; Unspecified 04 Nov 2017 No recent reports of development identified for preclinical development in Diabetes-mellitus in Europe (PO) 04 Nov 2017 No recent reports of development identified for research development in Undefined in Europe (PO) 22 Dec 2010 Early research in Undefined indication in Europe (PO) Oops, it looks like you dont have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following. Login with a username/password associated to an account with a valid subscription Contact your organizations admin about adding this content to your AdisInsight subscription If you are a subscriber to this content then contact us at [email protected] so we can help. Continue reading >>

Oral Insulin Could Still Be A Reality, Says Novo Nordisk

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 >>

Novo Nordisk Gets Close To Launching The First Oral Glp-1 Drug For Diabetes

Novo Nordisk Gets Close To Launching The First Oral Glp-1 Drug For Diabetes

Novo Nordisk Gets Close to Launching the First Oral GLP-1 Drug for Diabetes Novo Nordisk has positive Phase III trial results for its oral version of semaglutide, a GLP-1 based treatment for type II diabetes. This could be the first oral GLP-1 treatment on the market, making it easier for patients to take the drug. After obtaining approval for an injected version, Novo Nordisk is now getting ready to launch what could be the first oral version of a GLP-1 drug to treat type 2 diabetes. Glucagon-like peptide (GLP)-1 receptor agonists are a key innovation in first-line treatments for type II diabetes. They act by increasing the bodys levels of insulin, a hormone that lowers blood sugar levels, while decreasing levels of glucagon, produced by the body a hormone that increases blood sugar levels. Novo Nordisks oral semaglutide is a GLP-1 analogue taken once daily as a tablet, which would be more convenient for patients than treatments administered by injections. The Phase III results show that 80% of patients receiving the highest dose had low long-term blood sugar levels, compared to 34% of patients treated with placebo. If launched, it may be the first oral GLP-1 treatment for type 2 diabetes to enter the market. Out of the contenders in the GLP-1 treatment market, Novo Nordisks injected version of semaglutide along with Eli Lillys Trulicity stand out because they only need to be administered by injection once a week. Importantly, the injected version of semaglutide sets itself apart from Trulicity through greater reductions in blood sugar anddouble the amount of weight loss.Novos oral version of semaglutide could make the treatment even more accessible to patients. Eli Lilly remains confident in their market position, though, stating Novo will be competing with other, no Continue reading >>

Significant Blood Sugar Improvement With Xultophy 100/3.6 Compared To Insulin Glargine U-100 When Used As Add-on To Oral Diabetes Medications - Jun 23, 2018

Significant Blood Sugar Improvement With Xultophy 100/3.6 Compared To Insulin Glargine U-100 When Used As Add-on To Oral Diabetes Medications - Jun 23, 2018

Significant blood sugar improvement with Xultophy 100/3.6 compared to insulin glargine U-100 when used as add-on to oral diabetes medications Adults treated with Xultophy 100/3.6 (insulin degludec and liraglutide injection) 100 units/mL and 3.6 mg/mL also experienced no change in body weight, lower rates of hypoglycaemia and a lower insulin dose at 26 weeks ORLANDO, Fla., June23, 2018 / PRNewswire / --Xultophy 100/3.6 (insulin degludec and liraglutide injection) 100 units/mL and 3.6 mg/mL provided superior A1C reduction compared to insulin glargine U-100 (1.94% vs 1.68% respectively; p0.0001) when used as an add-on to a SGLT-2i (an oral diabetes medication), according to results from the DUAL IX study presented today at the American Diabetes Association's 78th Scientific Sessions (ADA) in Orlando, Fla. DUAL IX was a phase 3b, 26-week, open-label clinical trial that compared Xultophy 100/3.6 to insulin glargine U-100 in adults with type 2 diabetes uncontrolled on SGLT-2i treatment, with or without other oral antidiabetic drugs.1 Xultophy 100/3.6 is not indicated for use as an add-on to oral diabetes medications. Results from some of the secondary endpoints in DUAL IX included change from baseline in body weight, severe or blood glucose confirmed symptomatic hypoglycaemic events and daily insulin dose at 26 weeks. Mean body weight remained unchanged in the Xultophy 100/3.6 study group versus a 2.0 kg (4.4 lb) weight gain with insulin glargine U-100.1Treatment with Xultophy 100/3.6 demonstrated a 58% lower rate of hypoglycaemia versus insulin glargine U-100 (0.37 events/patient-year of exposure vs 0.90 events/patient-year of exposure respectively; p=0.0035). The average total daily insulin dose was significantly less with Xultophy 100/3.6 than insulin glargine U-100 (36 u Continue reading >>

Glucose Control With Oral Insulin Tablet Similar To Injection In Study

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 Matches Glargine In Phase Ii Trial

Oral Insulin Matches Glargine In Phase Ii Trial

SAN DIEGO – In an industry-funded phase II trial, researchers say they’ve shown for the first time that oral basal insulin tablets can safely decrease plasma glucose in patients with type 2 diabetes (T2DM). “Oral basal insulin appears safe and efficacious in insulin-naive patients with type 2 [diabetes] insufficiently controlled with medications. It improves glycemic control to a similar extent as does glargine,” said study lead author Leona Plum-Mörschel, MD, CEO of the German clinical research organization Profil Mainz, in an oral presentation at the scientific sessions of the American Diabetes Association. A statement from Novo Nordisk, the maker of the investigational medication, says the company discontinued development of the product due to its low bioavailability and concerns about the costs of producing it. According to Dr. Plum-Mörschel, researchers have been searching for an oral insulin treatment for almost a century without success. In the new phase IIa study, researchers tested a basal insulin analog tablet called OI338GT. It uses a technology platform called Gipet by Merrion Pharmaceuticals that aims to boost the absorption of injectable drugs when they are given in oral form. Researchers recruited 50 insulin-naive patients with T2DM (mean age 61 ± 7 years, mean BMI 30.5 ± 3.7 kg/m²) whose diabetes wasn’t properly controlled by metformin by itself or in conjunction with other drugs. All had hemoglobin A1c (HbA1c) levels between 7% and 10%. The patients were randomly assigned (1:1) to the investigational oral medication or subcutaneous insulin glargine (IGlar). They took the drugs once a day for 8 weeks in addition to their existing drug regimen. The researchers increased the doses on a weekly basis with a goal of reaching fasting plasma gluc Continue reading >>

Novo Nordisk Kills Off Oral Insulin Project

Novo Nordisk Kills Off Oral Insulin Project

Read more: How to (possibly) make oral insulin possible. The payer environment means that in mature areas, such as insulin, for instance, it is really a question of having a very high innovation threshold to justify new projects, Thomsen is quoted as saying in the report. This isnt the first time in recent memory that a major insulin manufacturer has backed away from a non-injectable form of insulin. Earlier this year, Sanofi formally ended its partnership to market Afrezza, an inhalable form of insulin. Both companies are seeing their once-steady profit margins slipping, as patents for basal insulin formulations run out and insurance companies balk at steadily rising insulin prices. That pressure on their profits isnt likely to abate anytime soon. Thats because politicians have finally started to call out the drugmakers who seem to raise the price of established drug therapies at will. After the initial firestorm over price spikes in an anti-AIDS therapy and the EpiPen, the pitchforks are beginning to point toward insulin makers. Just one tweet from Vermont Senator Bernie Sanders about the price increases of Humalog caused shares of Eli Lilly and Co. to lose 1 percent of its value; and that share price were already on a recent downward trend. Read more: Oral Dosing May Ward Off Type 1 Diabetes. There are researchers still working on ways to make oral insulin viable. Unfortunately, falling profit margins are not conducive for companies to take risks. That means if we want to see any cutting-edge advancement in new drug therapies for Type 1 diabetes, those therapies might have to be developed with companies in conjunction with non-profits. Already were seeing a test of that partnership, as JDRF recently partnered with Mannkind, the makers of Afrezza, to try and salvage Continue reading >>

Novo's Pioneering Diabetes Pill Impresses In First Big Study

Novo's Pioneering Diabetes Pill Impresses In First Big Study

February 22, 2018 / 10:51 AM / 7 months ago Novo's pioneering diabetes pill impresses in first big study COPENHAGEN/LONDON (Reuters) - The worlds largest diabetes drugmaker, Novo Nordisk, on Thursday presented the first successful data from a large final-stage study of a pill it hopes will transform the diabetes market. FILE PHOTO: The logo of Danish multinational pharmaceutical company Novo Nordisk is pictured on the facade of a production plant in Chartres, north-central France, April 21, 2016. REUTERS/Guillaume Souvant/Pool/File Photo The oral form of the drug, known generically as semaglutide, is crucial for ensuring the groups long-term growth, as price pressure mounts in a crowded market targeting the worlds 450 million diabetics. The new medicine is a threat to Eli Lilly, a key rival in the multibillion-dollar diabetes market. Novo said the first of 10 Phase III trials that are due this year had met its primary goal by demonstrating significant and superior improvements in long-term blood sugar levels compared to a placebo. The trial also showed that the highest of the three tested doses - 3, 7 and 14 mg - demonstrated significant and superior weight loss. While weight loss was also observed for two lower doses, they did not reach statistical significance. Importantly, nausea was not a major problem with the new pill, as some experts had feared. The companys shares rose on the news and traded 3.7 percent higher by 1230 GMT. The once-daily pill belongs to a blockbuster class of treatments known as GLP-1s that stimulate insulin production, the first of which were derived from the venomous bite of North Americas Gila monster lizard. So far, all have been injections. UBS analyst Michael Leuchten said the blood sugar reductions were as good if not better than those a Continue reading >>

Oral Insulin Reloaded

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 >>

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

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 >>

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