Oramed is developing a soft gel insulin capsule for the treatment of diabetes. The company has recently announced it the successful completion of its clinical trial demonstrating the safety and efficacy of the oral insulin gel capsule.

The pills were shown to reduce blood sugar, with no significant adverse effects. The insulin used in the gel caps is a generic brand of human insulin. The duration of the insulin is similar to Regular. But the most beautiful thing about these gel caps is that they reintroduce the liver into glucose metabolism, thereby reducing the likelihood of dangerous lows associated with injected insulin and oral medications. This could blow away the necessity of blood sugar testing because you are regulating glucose metabolism in the liver, like a person without diabetes.

Up until now, the idea of insulin pills or tablets was inconceivable due to the fact that insulin, when swallowed, breaks down in the digestive system. Oramed's patented technology overcame the problem of digestion as well as permeability to the intestine. The company's goal is for the completion of formal Phase 1 studies in the US by mid-2008. Sign me up!

Pfizer's bandwagon might be busted! Turns-out a study says inhaled human insulin, whether formulated as a powder or liquid, is more immunogenic than injected insulin.

Adverse effects of antibody formation have not been thoroughly investigated. But it was shown, comparatively, that inhaled insulin provokes more of an immune response than injections. Spitting is a dirty habit - but it's not good for nothing. The mucosal defense system is the body's primary line of defense against inhaled foreign matter - kind of like the MARINES of the human body. It is uniquely able to discern self from non-self bodies. So far - it looks like Pfizer's toker is a no go.

As I said before - the adverse events have not been thoroughly investigated. Until we know exactly what kind of mucosal revenge or pulmonary punishment lies ahead - I'd stick to the tried and true...subQ, for now. However the Generex Oral-lyn human trials are looking pretty promising. Stay tuned.

There's a story running on CNN Money about the progress of Oramed Pharmaceuticals' insulin capsule, which is currently under development. The capsule, taken orally, could provide a more convenient way for diabetics to get insulin than through shots. And popping a gel cap would, needless to say, also be more convenient than toting and blowing on one of those big old clunky Exubera inhalers.

In the quest to get its product to market, Oramed needs cash, and lots of it. Answering the call, a combination of private investors are putting up more than two million dollars in financing for the Israel-based company.

It's hoped the money will help to propel the insulin capsule through completion of Phase 1 (drug safety) trials by the middle of next year. Said Oramed CEO Nadav Kidron, "This investment marks a milestone for Oramed's stability, allowing the company to fully focus on its research and development efforts and complete its phase 1 product trials."

Stay tuned.

Did you know type 1 diabetes can take months or even years to develop? It makes perfect sense considering my entire family developed type 1 diabetes at varying points in the life cycle -- teen, young adult and middle-age.

Research has shown the pancreas is stubborn and strong, requiring the loss of over half of the beta cells before symptoms of type 1 kick in. Researchers are taking the next logical step and enrolling relatives of type 1 diabetics in various studies to try and delay or even prevent the onset of the disease.

The University of Florida Health Science Center and Shands at UF are one of 14 centers nationwide dedicated to Type 1 Diabetes TrialNet, a research group dedicated to a host of prevention and early treatment studies.

Now here is a study I feel like enrolling in. TrialNet is testing whether a one-a-day oral insulin capsule can prevent or delay onset of type 1 in high-risk individuals. An earlier trial suggested oral insulin might delay type 1 diabetes up to 4 years in a portion of participants with islet cell autoantibodies in their blood. Makes me wonder if I have any autoantibodies swirling around in my blood.

At the request of the Regulatory Affairs Manager at Generex, I am posting the following to defend the accuracy of the packaging and the claim of the product. The initial blog addressed a product called Glucose RapidSpray. The reader feedback, as well as the regulatory affairs response, is listed below. In no way, does Generex imply this product is to be used to treat hypoglycemia.

The comment to the original post stated:

The nutritional label on the product (available as a PDF on their web site) says the product has 188mg of carbs (or .188g) per serving (5 sprays). A typical glucose tablet has 4g... that's about 21x more carbs in a single glucose tablet than in 5 sprays of RapidSpray. Considering you typically use at least 15g of carbs to treat hypoglycemia, you would need around 80 sprays to get 15g of carbs into your system! When you take into account the amount of sprays you need, the calorie count isn't very much different from glucose tablets.

Read the label carefully, and be very careful using this!

The response from the Manager of Generex Regulatory Affairs states:

The product, Glucose RapidSpray™, is to be taken at the first sign of needing additional glucose in the diet, either between meals, during exercise, and/or before bedtime. It is not intended to take people out of full hypoglycemic states that normally a full tube of glucose gel or a full dose of Glucose tablets would be needed for. Glucose RapidSpray™ product is meant to be a complement to meals in order to help with glucose levels. As such, a direct correlation of carbs associated with Glucose RapidSpray™ and typical glucose tablets or gel is not warranted based on the intended use of the product. If usage of the product is maintained by taking Glucose RapidSpray™ at the first sign of needing additional glucose, then the Nutritional Facts stated on the package labeling is adequate for determining caloric intake (be it 5 sprays, 10 sprays, 15 sprays or whatever is taken to address the situation).

I consider the proactive response of Generex a good sign of how a company is run. Without needing to do so, Generex went above and beyond the call to address an open forum about the efficacy and accuracy of the product. This is the kind of interaction that convinces me a company cares! Good job, Generex! Lest I NOT hold my breath for Eli Lilly to return my call about Super Insulin. Novo Nordisk was far more receptive to address my interests, as a diabetic. Stay tuned for my follow-up on the Eli Lilly vs. Novo Nordisk – Who Love You, Baby!?!

The company making oral insulin a reality is distributing a teaser product to give you a hands-on example of the efficacy, ease and convenience their drug delivery system offers. Feast your buccal cavity on Glucose RapidSpray! The reality of oral-insulin is coming soon to the US - but its sugar stabilizing sister is here today!

Glucose RapidSpray can be taken at the first sign of the need for glucose, during exercise, between meals, or even before bedtime. It is simple to use and easy to carry. It comes in two different flavors, orange and raspberry, and there are no artificial colors. The main ingredient in Glucose RapidSpray is D-Glucose (dextrose), which is a simple monosaccharide sugar. Keep Glucose RapidSpray in your home, office, pocket, purse, or car (as long as it does not stay in sub-zero temperatures for too long). Interested in getting your hands on it?

The product is now available in over 2,500 stores in the United States at Aurora Pharmacy, Inc., Bi-Mart Corporation, The Diabetes Place, Fruth Pharmacy, Inc., Hy-Vee, Inc., Kerr Drug, Inc., The Medicine Shoppe® Pharmacy, Meijer, Inc., and ShopKo Stores. It is also available for purchase online at Glucose Rapid Spray and Diabetic Express.

This might be the first product from Generex you'll use, but it certainly won't be the last. Generex's flagship product is oral insulin, brand name Oral-lyn™. It is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, and is in various stages of clinical trials around the world. For more information, visit the Generex site or call 1-800-391-6755.

Those of us who don't have a metabolism like Sea biscuit might fall for the too good to be true ads every time. This time the object of my curiosity is Diamaxol. The product was formerly called Diabeticine, but the FDA didn't like the hint of medicine in the name, so the manufacturers changed it.

The product supposedly reduces blood sugar levels, eliminates (strong word) insulin resistance, and normalizes insulin production. A partial list of Diamaxol ingredients include: Banaba, Guggle (Guggul), Bitter Melon, Licorice extract, Cinnamon herb powder, Gymnema Sylvestre, Yarrow, Cayenne, Juniper Berries, Huckleberry, and Vanadyl Sulfate How exactly does Diamaxol claim to work it's magic? It's not magic - it's simply science. The magic behind the formula is actually the miraculous human body doing its job. Diamaxol is more like the stage crew for David Copperfield, rather than the show itself.

Diamaxol interferes with glucose absorption and prevents the stimulation of glucose from the liver. This effectively reduces blood sugar levels. It also eliminates insulin resistance by repairing cell receptors to better handle insulin. Scientists agree, insulin resistance is one of the leading causes of type 2 diabetes. The normalization of insulin production is restored (in type 2) and replaced (in type 1) by an organic compound. Curiously enough, banaba is at the top of the list of ingredients. Banaba contains corosolic acid, which activates the transport of glucose across cell membranes, resulting in blood sugar reductions. It has been used in the Philippines for years to treat diabetes. Because the FDA has approved Diamaxol as a supplement, at least we know that it can't hurt. Sounds interesting, perhaps worth looking into - but is it worth the $75 to $100 a bottle?

Scientists in Taiwan reported success in early tests of oral insulin in diabetic rats. The study showed the insulin pill combination reached the rats' bloodstream and lowered their blood glucose levels.

Insulin is a pure protein and therefore must be protected from the digestive enzymes in the stomach and small intestine. Scientists found that chitosan, a chemical derived from the shells of shrimp, crabs, and lobsters allowed insulin to reach the blood stream without degradation. Chitosan encapsulation provided a protective barrier for the insulin while traveling through the stomach and small intestine.

An oral drug would be the most convenient way of delivering insulin. No more needles, no syringe - brought to you by chitosan! It almost rhymes -- but nonetheless, it's music to my ears.

I've mentioned the possibility of oral insulin a few times before, and I'd like to reiterate some exciting news. A recent study confirms that Generex Oral-lyn is as effective as injections in controlling after meal blood sugar rises. The study compared the effects of two forms of mealtime insulin treatments in patients with Type-1 diabetes. The patients were all on 2 daily injections of NPH insulin for long-acting blood sugar control. The study measured the efficacy in treatment of after meal blood sugar spikes.

To treat after meal blood sugar rises, 11 subjects in the control group received three pre-meal injections of regular insulin. The 14 subjects in the treatment group received three split-dose applications of Generex Oral-lyn (i.e. RapidMist puffs of Generex Oral-lyn) before and after meals. The fructosamine and glycated hemoglobin (HbA1c) were checked approximately every 2 weeks to determine the efficacy of treatment. The study demonstrated that both Generex Oral-lyn and mealtime injections of regular insulin achieved near normalization of blood glucose. This measurement was made based on the continuous improvement in fructosamine and HbA1c levels. However, a straightforward comparison of HbA1c levels showed a superior effect for Generex Oral-lyn.

By providing a simple and effective alternative to mealtime insulin injections, Generex Oral-lyn is designed to improve patient compliance which is likely to improve diabetes control, thus reducing the risk of long-term complications. This study prepares Generex for a pivotal late-stage, long-term trial of Generex Oral-lyn which will begin early in 2007. This is sounding more promising with every press release. Thanks to the tenacious women behind the genius of Generex - we won't have to hold our breath too long before we see oral insulin. Way to go, ladies!!

Generex's flagship product, Oral-lyn^TM, is an oral insulin spray for the treatment of type 1 and type 2 diabetes. Their technology permits the delivery of insulin through the oral cavity (with no deposit in the lungs). Whatever you do, don't call it an inhaler.

Oral-lyn^TM is a liquid form of human insulin that is absorbed through the buccal mucosa. Say that three times, fast. It is delivered through the RapidMist^TM device, which looks a lot like an inhaler. But because this device limits absorption to the mouth, there is no entry into the lungs. The rich vascularity of the buccal mucosa allows for much faster absorption of insulin and a shorter total duration of activity which makes Oral-lyn^TM an ideal mealtime insulin, as it can be conveniently administered immediately prior to meals with little prospect of hypoglycemia. Oral-lyn^TM can be used as a preventative agent by people with pre-diabetes to delay the onset of diabetes and by patients with type-2 diabetes to delay the onset of insulin dependence and the complications associated with diabetes.

Generex Oral-lyn^TM is expected to lead to an enormous improvement in the quality of life, with the elimination of pain and a significant increase in convenience. This will result in improved compliance with a relative decrease in complications and a significant reduction in the costs associated with treating them. Knowing now that you can non-invasively continuously monitor your blood sugars, patch on your basal rate, and puff (but not inhale) for your meals - I'm going to do my share of screaming from the hilltops to get these devices the attention they warrant.

Dear Mister FDA, please don't give any of these potential pipeline treatments any shenanigans. They deserve a bedtime story and a kiss on the forehead for the promise they bring to us in the cold, weary world of diabetes. Oh yeah-- and please put a little hustle in it! Yours truly, Allie B

Much effort and research has been invested in finding an alternative, less painful way, to treat patients with diabetes. For years, the only method patients had to deliver insulin was by injection. However, a team of scientists discovered a technology that has the potential to revolutionize this old school way of thinking. What if I told you a company is developing an orally ingestible soft gel insulin capsule? Naysayers, allow me to introduce you to my latest find: Oramed.

Up until now, the idea of insulin in a pill was inconceivable due to the fact that insulin, which is a protein, breaks down in the digestive system. However, Oramed's patented technology overcame the problem of digestion as well as permeability to the intestine with a few organic whistles and bells. This has been a major hurdle that has inhibited the development of orally ingestible insulin for decades. Prof. Hanoch Bar-On, a leading Diabetologist, states that the route of the insulin from the swallowed pill "imitates nature" in that it passes to the liver and then to the bloodstream. Injected insulin goes straight to the bloodstream.

Oramed Pharmaceuticals' is an Israeli based company. They received the green light from the Israeli Ministry of Health, as well as the Hadassah Medical Center Institutional Review Board for phase 1 clinical trials of oral insulin in healthy humans. Here's the million dollar question for card-carrying US citizens with type 2 diabetes taking insulin injections: if you could downshift to an easier to swallow means of managing your diabetes, would you?