A Drug That Does Double Duty In Treating Diabetes
The results were recently published in Nature Biomedical Engineering.
Developed by Tarek Fahmy, associate professor of biomedical engineering and of immunobiology, the drug has two critical advantages over the standard treatment for diabetes. Because it can be taken orally, its much simpler for the patient to stay compliant with his or her treatment. It also addresses three major issues with diabetes at the same time: it helps control immediate blood glucose levels, restores pancreatic function, and re-establishes normal immunity in the pancreatic environment.
What excites me about this is that its a two-pronged approach, Fahmy said. It’s facilitating normal metabolism as well as correcting immune defects in the long term.”
He notes that it’s all done within a nanocarrier composed of materials that our our own bodies make – bile acids – which means that the carrier itself has therapeutic effects that works with the loaded agent to reinstate normal metabolism in the short-term and restore immune competence in the longer term.
“This combined approach is what makes this system a promising new therapy for autoimmune disease in general, he said.
One of the major obstacles to creating a successful oral medication for diabetes is that the drug breaks down in the patients gastrointestinal system. The nanoparticle, however, protects the insulin while carrying it to the site of the pancreas, where it unloads the medication.
A New Nanomaterial Could Lead To Safe Effective Oral Delivery Of Insulin And Eventually Be Used As A More General Drug Delivery Platform
Oral delivery of insulin and other protein-based drugs can be challenging, as the acidic conditions of the gastrointestinal tract can break them down, rendering them ineffective. Also, the intestinal membrane is poorly permeable to insulin. Some peoples fear of needles and self-injection makes it difficult to start insulin therapy, and though insulin pens can overcome these problems, they are costly and can lead to incorrect dosage delivery. A safe and effective oral delivery method would be of great benefit in diabetes care.
To address these issues, researchers developed an imine-linked covalent organic framework a crystal lattice of two organic molecules, TTA and DFP. The researchers were drawn to the idea of using this for insulin delivery, as TTA-DFP-nCOF is stable even under acidic conditions. But they had doubts that the material could absorb insulin, as the layers, which are stacked a few nanometres apart, are positioned such that one layer partially obscures the pores in the next, meaning insulin might not be able to sit in the pores.
It turns out the insulin makes its way through the sheets and interpolates between them, says senior author Ali Trabolsi of New York University Abu Dhabi. That was quite surprising. Even more surprising was the materials high insulin loading capacity.
13 November 2013
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Efforts To Retrieve Supplementary Data
Due to the scarcity of publicly available clinical trial results, alternative sources of information were consulted. Additional information was gathered from press releases, company websites, and clinical trial registries. The 13 companies that state to clinically develop oral insulin formulations were contacted directly via mail and/or email and asked to provide any amount of published or unpublished information on clinical development of their oral insulin candidate. Only 1 company responded and provided results from 2 recent, unpublished clinical trials.,
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In experiments done on mice, the oral medicine not only swiftly adjusted insulin levels but also restored metabolic functions and reversed inflammatory effects of the disease, basically doing double duty in treating type-1 diabetes, which affects approximately 1.6 million Americans.
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Clinical Development Of Oral Peptide Formulations
There are important learnings from the important oral peptide delivery research conducted by Novo Nordisk. Their approach to creating oral semaglutide and oral insulin formulations was to consider two aspects in parallel. The first was to use medicinal chemistry to create long-acting potent stable peptides using modified and acylated amino acids to form moieties that could associate with human serum albumin in the case of semaglutide and to protect against luminal peptidases in the case of the modified insulin, IO338 . These modifications were accompanied by studies showing that there was no reduction in receptor binding and efficacy for either peptide. The second parallel approach was to formulate the peptides with well-established permeation enhancers in solid dose formulations. The oral semaglutide formulation with SNAC made it to market, but the insulin one with C10 did not. The outcome from the discontinued oral insulin programme suggests that a commercially viable oral insulin formulation might still be possible if the oral bioavailability of a modified basal insulin could perhaps be increased to 10% in humans, as this would reduce the cost.
What Is The Best Herbal Medicine For Diabetic
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What Are The Side Effects Of The Non
The meglitinides may cause hypoglycemia and weight gain.
People taking biguanides may develop lactic acidosis, a rare but severe side effect. Excessive alcohol intake while on metformin can contribute to development of lactic acidosis. Other side effects include metallic taste in the mouth and diarrhea.
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Alpha-glucosidase inhibitors may cause gastrointestinalproblems , although they are usually fleeting.
Side effects of exenatide may include slight weight loss, nausea, vomiting, and diarrhea.
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Two Pills For Type 1 Diabetes Under Us And European Review
Farxiga and Sotagliflozin are the first pills to seek approval as add-ons to insulin for type 1 both bring strong time-in-range benefits, and if approved, might launch in 2019
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For the first time, regulators are reviewing two pills as potential adjunct or add-on therapies for adults with type 1 diabetes to take in addition to insulin. The European Medicines Agency is considering Farxiga, an SGLT-2 inhibitor taken as a once-daily pill, while both the EMA and the FDA are looking at sotagliflozin, an SGLT-1/SGLT-2 dual inhibitor that does not yet have a commercial name. Reviews generally take about a year, meaning that Farxiga and sotagliflozin could be approved in the first few months of 2019.
These medications cant replace insulin in type 1 diabetes care. But they do usually lower insulin dose requirements while helping to reduce highs and lows and contributing to weight loss.
Both of these medications are taken as a once-daily pill and work independently of insulin: glucose is released through the urine when blood sugars are high, and then the drugs stop working when glucose levels come down.
The study evaluating sotagliflozin also showed A1c and weight loss benefits:
Managing Glucose In T1d Once Had But One Treatmentinsulin
The first and primary medication given to someone with type 1 diabetes is insulin. This has been our standard approach to treatment since the discovery and development of exogenous or sythetically produced insulin in humans for more than a century. The two insulin options originally approved by the Food and Drug Administration to manage blood sugars in people with type 1 diabetes areinsulin and Symlin.
Insulin is the essential treatment to manage blood sugar in people with type 1 diabetes. There are many devices available to help you take insulin.
Treating T1D is all about the amount and timing of insulin, as well as the best way for you to get the right dose of this essential hormone to assure that the glucose circulating in your bloodis able to be properly absorbed by your body. Glucose is the main source of energy that your body uses to keep all key functions running properly.The trick is that in order for your body to properly take in and use blood glucose properly, insulin is required to make this reaction work.
Insulin was first successfully used in humans in 1922. Originally, it was made by extracting it from the pancreas of animals: dogs, cows, and pigs, specifically. But by 1978, insulin was created synthetically, or exogenously, meaning it is now made in the lab. You can read more about insulin.
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Be Open To Additional Therapies To Improve Your Glucose Control
Therefore, it is always good to have a conversation with your healthcare professional about the benefits of using such medications and also inquiring about what the cost of taking a recommended medication may mean to you.
Your healthcare provider will choose the insulin will depend upon many things including the expiration date for insulin once the vial or pen is used for the first time as well as their onset , the peak and duration .
Of course, your level of physical activity level, the presence of a fever, and stress level as well as your usual meals and snacks , will also be considered when planning for your insulin needs.
Diabetic Patients Get Ready: An Oral Insulin Capsule That May Soon Be On The Market
Nearly half a billion people worldwide suffer from diabetes.
Many will eventually have no other option but to use insulin. Until now, insulin was only available via injection or an inhaler. One company just took a huge step towards a much-anticipated alternative: an Insulin capsule.
Oramed Pharmaceuticals Inc. , a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, just announced unprecedented topline data from the second and final cohort of its Phase 2b trial evaluating the efficacy and safety, at lower dose regimens, of its lead oral insulin capsule, ORMD-0801.
While many huge corporations have spent millions of dollars trying to create an oral insulin pill, none have succeeded so far. This new development, which signals the first commercial oral insulin capsulefor the treatment of type 2 and type 1 diabetes, might be the game-changer that revolutionizes the treatment of diabetes.
Established in 2006, with offices in New York and Israel, Oramed has developed a Protein Oral Delivery technology that is based on more than 30 years of research by scientists at Jerusalem’s Hadassah Medical Center.
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