The results are looking good for the first-round of human testing for Oral-lyn, Generex's flagship product. The oral insulin, delivered into the body through the oral cavity (with no deposit in the lungs), is as effective as injected insulin.

The efficacy of Oral-lyn for controlling blood sugar was decidedly as good as multiple insulin injections. The research found that regular insulin and Generex Oral-lyn had similar effects on lowering blood sugar in subjects with type 1 diabetes. The subjects received twice-daily insulin analogue for basal coverage. So this might rewind some of us old timers to the days long-gone where we could get by with two shots. Period. If Oral-lyn makes it to the local pharmacies - maybe mealtime corrections could be easy to swallow. Praise patient compliance!

On an even more impressive note - it looks like the mucosal membrane in the lungs is giving Exubera negative challenges to overcome. Perhaps Oral-lyn will come out looking a little more pristine in this capacity, since it doesn't go anywhere near the lung membranes. I'm not in favor of diabusiness - but for crying out loud - I'd like to see some companies start working for their money. Generex is one of those companies with the Big Idea!

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.

Remember back in 2006 all the buzz surrounding Exubera, Pfizer's inhalable insulin product? It was much-hyped by Pfizer and, let's face, the media happily joined in too, spreading the word that (as Pfizer would have it) Exubera would be wildly successful and make squillions of dollars for investors.

It didn't work out that way at all. Sales so far have topped out at around four million dollars per quarter, far short of the two billion projected before the product was released. Now, in a bid to lift lackluster sales, Pfizer is launching a major ad campaign for Exubera. Yes, the inhaler device is extremely indiscreet. Yes, long-term use of the drug itself could cause lung damage. Oh, and health insurers may not cover prescriptions for Exubera for those diabetics who want to try it. But I guess where there's a slick selling strategy there's a way...into the pockets of consumers, that is.

Which is not to say I blame Pfizer. The company has poured so much money into this product, does it really have a choice at this point? No. Also, it's entirely possible Pfizer could turn things around. This article by Arlene Weintraub for Business Week reminds readers that the drug giant had enormous success with its clever ad campaigns for Viagra and for the incontinence drug Detrol. Writes Weintraub, this new campaign will probably cost Pfizer big-time: we're talking tens of millions of dollars, but it will be worth it for Pfizer if it can reproduce that kind of success.

I apologize for covering a topic that may have very well been covered already a few weeks ago, but the way I see it, if the entries on this page change too quickly for the bloggers to keep up, it must be extra tough for the readers. That all being said, I wanted to point out the mixed results of a recent study on inhaled insulin (or the insulin bong, as I like to call it).

For people with type 2 diabetes, taking extra insulin during mealtimes is a necessary step in helping to regulated blood glucose levels. These doses are taken in addition to baseline insulin that is taken throughout the day and night. What researchers at the ECRI Institute have discovered is that inhaled insulin may improve blood sugar control for people with type 2 just as well as short-acting insulin taken by injection.

After a three-month period, the researchers found the inhaled insulin to produce equally as effective results in patients than insulin shots. The tricky part, however, is that the inhaled insulin seemed to be a bit problematic for users who experienced low blood sugar levels -- hypoglycemia.

Despite the mostly positive results, inhaled insulin still gets mixed reviews from researchers. Not only is its problem dealing with hypo a...well, a problem, but speculation also surrounds the long-term effect of inhaled insulin on the lungs.

Inhaled insulin was approved by the Food and Drug Administration in 2006. A new review of the body of published research on inhaled insulin reveals positive and negative results. Keep in mind, this body of research is lean and only covers a six month window of follow-up.

Researchers examined eight studies involving 1,881 patients with type 2 diabetes to compare inhaled insulin, injected insulin and oral medications.

On the positive side, inhaled insulin worked as well as short-acting injected insulin to control blood sugar over three months. Inhaled insulin can also improve blood glucose control for type 2s who have not had good results with short-acting insulin taken on top of baseline insulin. But inhaled insulin users had more difficulty controlling low blood glucose (hypoglycemia).

For patients who had never taken any form of insulin, inhaled insulin alone was better than oral medications to control blood glucose levels at a three-month follow-up. But again, higher rates of hypoglycemia occured for patients taking oral medications plus inhaled insulin.

Researchers point out existing evidence on inhaled insulin for type 2 patients is unable to answer important clinical questions regarding patient satisfaction, inhaled insulin's effect on other diabetes complications, weight gain and one of the most important issues, long-term impact on lung function. Additionally, inhaled insulin dosing is not as precise as injected insulin, but companies are working on the problem.

Phosphagenics Limited is developing a skin gel that administers insulin. They are currently testing the effect of long-acting insulin in the patented formula.

Research has demonstrated that a single application of the insulin gel rapidly delivered insulin into the bloodstream without any adverse reactions. Additionally, it significantly lowered blood glucose, insulin and c-peptide levels.

The company has been working on improving drug effectiveness and cost efficiency through a process called phosphorylation. Many enzymes and receptors are switched "on" or "off" by phosphorylation, including the glucose lowering properties of insulin. Once inside the skin -- enzymes activate these properties, impacting the blood sugar. This does not cause irritation to the skin, allows for a sustained release of medication in just one application, begins to take effect within an hour of application, can be used with many forms of prescriptions (small and large molecule medicines), and is economical to produce.

If it significantly reduced c-peptide levels, this might be more appropriate for type 2 diabetics - for a temporary basis. Judging by numbers, majority rules and since 80% of diabetics are type 2...this could be a feather in the capitalists cap for pain-free insulin delivery. However, if blood sugar control becomes as easy as a handi-wipe, how motivated will anyone be to eat right and exercise? Wash your hands for dinner, please.

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!!

What is all the diabetic buzz about these days? Byetta and Exubera are certainly two biggies. My intention is to tantalize your interest in these juicy topics and leave a little to the imagination. Don't fret, I have a direct route to the quickest answers to any burning questions about these monster topics.

Byetta is getting a lot of attention nowadays. It comes from a poisonous lizard, the Gila monster. So quite literally, it really is monstrous. But don't let that discourage you from looking into it as a potential enhancement to your diabetes management. Many people have been pleased with its appetite suppressing, weight reducing attributes. Call it a shot of heroism -- since you must take it by injection. Traditional drugs to treat type 2 diabetes tend to cause a surge in appetite and weight gain. Could Byetta be the brute force to reckon with these dispiriting effects?

Exubera, what do you have to say for yourself? You can start by bragging that over 90% of the patients who tested you in clinical trials have chosen to continue using you. So the question is does this stuff work? It sounds like the answer is a resounding YES. Exubera is the newest form of insulin to hit the market since the debut of insulin, around 1890 (but please, don't quote me). You inhale it! The common concerns for this delivery of insulin include: how accurate is the dosing? What will be the long-term effects on your lungs? How long does the inhaled dose last? Will it need to accompany injections of longer-acting insulin? View the dLife TV interview with Dr. David Nathan, of Massachusetts General Hospital, and Ed a type 2 diabetic who has used Exubera for 9 years.

dLifeTV clears the air with answers to some of the common questions about Byetta and Exubera. Watch dLifeTV, airing every Sunday evening on CNBC, 7:00 PM on the East coast, 6:00 PM Central time and every Sunday morning on DIRECTV channel 251 at 7.30 AM Eastern time zone.

I reported on this new drug earlier today; here's an update. If you are diabetic and are considering asking your doctor about new inhaled insulin Exubera, there's one thing you should know: If you are inhaling insulin you should not be inhaling cigarette smoke. Study researchers have found that smoking greatly affects how Exubera is absorbed into the bloodstream, altering its potency and insulin levels. And rapid changes in insulin levels can result in very low blood sugar levels.

In fact, doctors involved in the study recommend that if diabetics want to use Exubera, they should stop smoking at least six months before starting it -- and make sure to stop the treatment if they start smoking again. So, if you're tracking this drug (available this summer, about six months from now) and are a smoker anxious to rid yourself of the daily injections, this might be just the impetus you're looking for to stop a habit that carries so many obvious risks. And it will certainly help you breathe easier on several levels.

That's the latest. I'll continue to track developments surrounding this drug. If any readers have more information, let me know.