There is still no evidence to declare superiority of rapid-acting insulin analogues in the treatment of type 1 diabetes. These studies compared either insulin aspart (NovoLog) or insulin lispro (Humalog) with human insulin; no such study was available for glulisine (Apidra).

Based on average HbA1c values, patients treated with NovoLog had lower levels. However, statistical comparisons were so small that an effect on patients' health is not to be expected. It was also hypothesized that Humalog may prevent night time lows better than Apidra.

Even though patients have been treated with insulin analogues for 10 years, it is still unclear as to how these types of insulin affect long-term complications of type 1 diabetes. The long-term effects of insulin decisively increase the risk of heart disease and cancer, according to recent studies at Howard Hughs Medical Institute. Would you be surprised to learn that one of the insulin analogue manufacturers chose to withhold some of the results of their studies?

Meet the Face of Change is a photo exhibit owned by Novo Nordisk featuring YOU -- the face of change. Change for what, I asked? Well, it seems Novo would like to change your opinion of the barriers to insulin treatment for Type 2 diabetics. The common belief of insulin treatment for Type 2 diabetes is that it is the point of no return. Why? First instincts are usually correct.

Studies have shown that Type 2 diabetics injecting insulin create insulin antibodies (IAA). Type 1 diabetics have these antibodies upon diagnosis. Type 1 diabetes was also formerly referred to as insulin-dependent diabetes. Insulin antibodies (IAA) develop and attack the natural insulin produced, resulting in insulin dependence. Type 2 diabetics do not have the same level of IAA. Once they begin injecting insulin that looks like human insulin (the kind Novo makes) - you run the risk of developing IAA. The use of animal-insulins did not cause the development of IAA to the same extent. If you plan to start injecting insulin - ask your doctor if he will check you for IAA. As a Type 2 diabetic, you DO NOT have to become an insulin-dependent diabetic.

I asked Novo to explain what Meet the Face of Change is about. What are they trying to change? The response I received from Nov explains their wishes to strengthen the drive of their business, among other core values. Now I ask you - how do you drive a business that sells insulin? Sell more insulin. For the 16 million Type 2s not yet in this lineup- please consider if insulin-dependent diabetes is the face you want to meet. Don't add insulin to injury. It may not be the path of least resistance, but cut back on simple sugars, increase fiber consumption, and take a walk after dinner. Meet the face of change by putting your best foot forward, not your face on a campaign for vulture capitalism.

When blood sugar is falling, the stopper built into the body is the release of glucagon from the alpha cells of the pancreas which stimulates the release of glucose from the liver (but only if your adrenaline is flowing). However, when hypoglycemia is due to injected insulin - the stopper isn't entirely in place. Scientists explain how epinephrine (adrenaline) plays a major role in regulating glucose in times of low blood sugar and how this response could be adversely affected by the use of beta-blockers.

During insulin-induced hypoglycemia in dogs, the roles of adrenaline and glucagon were evaluated. The dogs fasted overnight to remove excess glucose from the blood. The dogs also had their adrenal glands removed. The adrenal glands are the source of adrenaline. Adrenaline is released into the bloodstream in response to physical or mental stress,to initiate the stimulation of glucose, among many other functions. Adrenaline and insulin were released at two different rates: a basal rate or a variable rate to simulate an adrenaline response. When the blood sugar fell to 42 mg/dL, the dogs in the basal rate group failed to release glucagon, but the simulated adrenaline response group increased normally. The liver response to releasing glucose fell in the basal group but increased in the simulated adrenaline response group. The researchers conclude that adrenaline must be responsible for this critical response to insulin-induced hypoglycemia.

Beta blockers are a common class of prescription drugs that counteract the stimulatory effects of adrenaline. Diabetics who inject insulin and take beta-blockers should be extra cautious of hypoglycemia. Hypoglycemic unawareness is already established for diabetics injecting GM insulin (genetically modified human insulin). Given the side effects of beta blockers, there is greater reason to be more aware of hypoglycemis unawareness -- yes, oxymoron. Those individuals who are on the brink of diabetes should avoid beta-blockers at all costs, according to a study in The Lancet (January 2007) beta-blockers used for hypertension increase a patient's risk of developing diabetes.

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!?!

Remember the A-Game suggestions I dangled for Eli Lilly to tap for performance enhancement? Well here it comes. I called Eli Lilly headquarters to speak with the Chairman and CEO, Mr. Sidney Taurel but I was directed to their idea submission form (which consequently didn't work). Oh boy, Sid. I'm a little disappointed. So here goes - my idea is going free for all when you could've had it, first. Let's call this new and improved product Beta Juice. It delivers the essential functions of a fully operational beta cell. It produces: insulin, amylin and c-peptide. Here's why insulin should always come equipped with the other two...

Insulin brings sugar to the cells to keep our energy levels sufficient for life, homeostasis and (if we're lucky) some energy for the gym. Amylin is a controlling agent for appetite, gastric emptying and tells the liver to dispatch glucose. It is also shown to have an impact on lipolysis --- the metabolism of stored fat. Until recently C-peptide was nothing more than a number used to decipher if you were a type 1 or a type 2 diabetic. However, recent scientific studies have shown C-peptide protects small vessels from the complications associated with diabetes. The Reuters Health article is titled C-Peptide Replacement Improves Early Diabetic Neuropathy.

The American Diabetes Association promotes the ABC's of Diabetes Care in an effort to educate diabetics on controlling their disease. The ABC's of diabetes care refer to a patient's Hemoglobin A1c, blood pressure, and cholesterol. A diabetic must maintain a hemoglobin A1c less than 7%, their blood pressure must remain below 130/80 and their good and bad cholesterol must be kept in range. The ABCs of Diabetes Care were established in order to reduces the chances of developing diabetic complications like neuropathy (nerve damage), nephropathy (kidney damage) and retinopathy (eye damage).

Here comes the perfect Insulin (code name Beta Juice) -a laboratory engineered balance of insulin, amylin, and C-peptide. Insulin to balance the blood sugar level, amylin to regulate fat and cholesterol levels and C-peptide to control the damage inflicted upon the micro vessels throughout the body. This is a GREAT IDEA!! Not just because it is MY idea, but because this is a huge opportunity to mitigate the complications that insulin by itself can impose, without the checks and balances of the other beta cell hormones. What do you say, Eli Lilly? You're halfway there!! You've already partnered with Amylin Pharmaceuticals. They have one third of this patent pie. Now hop on the horn and join forces with the C-peptide patent holder and ride your stock price to the moon. The diabetic girl has spoken. I know you care, Eli Lilly. Now put your money where your mouth is and make this new and improved insulin a light at the end of the diabetes tunnel.

Eli Lilly is introducing a unique insulin pen named the Memoir. It is the first on the market with a memory device to track doses administered. It is designed for use with Lilly's top-selling insulin, Humalog.

The battery-operated pen uses a computer chip to remember the last 16 insulin doses. And while insulin pens are popular in Europe and Asia, only about 800,000 of the 4 million U.S. diabetics who take injections use a pen-- most use syringes. It won't be too surprising if insurers and patients balk at the $100 sticker price for the pen alone. There is a separate fee for the insulin cartridges. I agree, it's a little pricey. Lilly plans to ignite the marketing campaign by offering a $45 coupon. Good start. This pen has been under development for seven years. Lilly plans to introduce two other pens this year to increase Humalog demand. I've got an idea (since nobody asked, but I was a former user). I traded up to Apidra because I became irate every time Humalog clogged my infusion set for my pump. Go back to the drawing board with that quandary while I'll work on my honey do list for product development.

Neither here nor there - my point is this: Eli Lilly you can be everything you want to be if you listen to your customers. The number of insulin-taking diabetics is rising along with the bar on product ingenuity. It's game day, Eli Lilly. I have more ideas to help bring out your A-game. Stay tuned...

I just read that the US Food and Drug Administration (FDA) has announced that it is re-classifying the drug NovoLog to allow its use by women with Type 1 diabetes who are pregnant. NovoLog is manufactured by drug-producing giant Novo Nordisk. The change came after a trial which found that pregnant women with T1 diabetes who took NovoLog had HbA1c levels and rates of maternal hypoglycemia comparable to women on regular insulin. The study did not, however, evaluate whether babies whose moms take the drug while pregnant have a greater risk of congenital malformations. On the other hand, women taking NovoLog benefited from a lower risk of diabetes-related pregnancy dangers such as preterm delivery.

Pregnancy and drugs. It's a complicated issue. What's safe? What's not? If only it were so simple as dividing all drugs into one category or the other - the Good or the Bad. Unfortunately, many common medications are in a third category - the Ugly? These drugs, known as category B drugs, constitute a sort of pharmaceutical no-man's land. You see, these meds have not been proven to cause harm to unborn children, like category C drugs. Yet they have not been proven safe, either, like category A drugs. This means, as I discovered when I was pregnant in 2006, if you're sick and could benefit from some specific No-Man's-Land drug, odds are your doc will offer to write you a prescription for it. He or she will warn you that it's possible the drug causes harm and leave the decision of whether or not to take it up to you. Now, I don't want to go back to the Bad Old Days when doctors told patients "do this" or "do that," "take this" or "take that," and, by golly, you did it and didn't ask questions. But wouldn't it be nice to just know what to do? Or to know that your doc knows all the answers? What's a gal to do??

In 2005, insulin cost state Medicaid programs $500 million. The diabetes epidemic is causing the government to question one of the big-ticket items on the shopping list - insulin. Insulin was developed over 20 years ago and many of these original forms are now off patent. This is a screaming opportunity for generic drug makers to prosper and government programs to save.

Two of the largest insulin makers, Novo Nordisk and Eli Lily, say they are opposed to any F.D.A. action that would approve generic insulin without clinical studies. Why the concern? The combined sales in the United States for Humulin and Novolin is about $1 billion. No wonder.

A drug maker needs to prove the generic version contains the same active ingredients, purity and quality, and provides equivalent delivery over time as the brand-name version. However the makers of generic drugs agree that the approval process for generic biologics, like insulin, would be more complex than the current shortened process for other generic drugs. Anybody have a guess as to what the hold up is for this much needed and overdue generic insulin explosion?

Back on the 23rd I blogged about Will Cross, the Type 1 diabetic mountain climber who was set to make his third attempt to climb Mount Everest, the world's highest mountain. Well, he made it to the top! Yes, it has been announced that Cross made it to the summit of Everest, which is apparently the highest point on earth on which humans can walk without supplemental oxygen.

Cross (39) is a father of six and comes from Pittsburgh. His endeavor was sponsored by NovoLog (insulin), manufactured by Novo Nordisk. Climbing Everest means Cross has now completed the NovoLog Peaks and Poles Challenge, which entails climbing the highest mountain on every continent and trekking to the North and South poles(!). Cross relied on the NovoLog FlexPen disposable insulin delivery device during his grueling journey up Everest.