Shhh. Big Pharma scientists hard at work. On what, you ask? Why, on Novo's new "baby" - a drug designed to treat type 2 diabetes. Liraglutide, a hormone analogue, is supposed to improve blood sugar control. It's also supposed to get you that coveted magic bullet (a la Byetta): weight loss. Ooh, baby. Now that's medication!

Novo Nordisk has been working on Liraglutide for a while now. Here's the latest: Novo announced Monday that two Phase III studies were successful in demonstrating the aforementioned blood sugar control and weight reduction. Novo is riding high on the news: its shares rose six percent on the announcement. According to a pharmaceutical industry analyst quoted by Reuters, the shares surged so healthily because the positive news was expected.

The powers-that-be at the drug giant say they hope Liraglutide can be submitted for regulatory approval by mid-2008. They hope it will become another blockbuster, with estimated annual sales topping one billion. Stay tuned.

Diabetes drugs Byetta and Januvia have been declared safe and effective...for now...by researchers from Boston's Tufts-New England Medical Center. Both medications effectively reduce blood sugar by around one percent or less. This compares with older drugs like metformin, which can cause a drop of as much as two percent. On the other hand, the newer drugs are popular (and this has received tons of publicity over the last year or two) because they don't routinely cause weight gain like the older drugs and, in fact, they can even promote weight loss.

The Tufts announcement came with a caveat, however: these drugs have not been around long. This means their long-term safety is not known. As far as side effects go, one author of the study, Anastassios Pittas, told USA Today that although they didn't see anything really scary, "I would be more comfortable seeing two-and three-year data before embracing them." Pittas also acknowledges the (exorbitant) cost of Byetta and Januvia is a problem.

No new research was done to arrive at this conclusion. Rather, the researchers assessed the findings of twenty-nine previous studies. Their report has been published in the latest issue of medical-world heavyweight Journal of the American Medical Association.

The timing of this news is indeed fortunate for drug giants Merck & Co., which owns Januvia, and Amylin & Lilly, which owns Byetta. They must be very worried indeed about shaken consumer confidence following the Avandia mess, which has received a lot of publicity of late - bad, very bad, publicity that tarnished the public image of Big Pharma. And it's public image was already down about level with lawyers. (Apologies to all the lawyers out there...)

Change appears to be coming for diabetes care. The HbA1c test may not be the safest approach for diabetics to follow in preventing complications. Instead, experts are saying the average blood glucose level per individual will add clarity to diabetic patients looking to manage their disease.

A study supporting the change showed a close correlation between average glucose and HbA1c levels. So the myth, busted is: maintaining an average blood sugar is a safer approach for diabetes management -- NOT CHASING A UNIFORM HbA1c value. The fluctuation in blood sugar is what causes complications in the small vessels of the eyes, kidneys and peripheral nerve endings. For example - sustaining a blood sugar of 200 mg/dL is a lot safer than waking at 240 and ushering a boatload of sugar into your cells to drop your sugar to 80 mg/dL. It is the transfer of glucose into the cell that causes the injury to cell membranes and resulting complications.

Think of it like the movement of the ocean. High tide to low tide happens gradually, over the course of many hours throughout the day. When a storm hits - the waves become turbulent, crashing against the shore causing erosion. Is the human body any different? I'm not a doctor -- but I did stay at a Holiday Inn Express last week.

I was excited to see my friend, Lissa Coffey, appearing on The Today Show this morning. Lissa is a PhD, a relationship expert and sociologist. Lissa shares her ancient wisdom and modern style through her site, Coffey Talk, and her newsletters. A recent newsletter addressed homeopathic medicine and I share with you how this applies to the treatment of diabetes.

Homeopathic medicine is a natural pharmaceutical science developed in the early 1800s. It uses small doses of natural substances (animal, vegetable, and mineral) to stimulate the body's own defenses. Homeopathy is a word derived from the Greek words for similar and disease. It is medicine based on the law of similars that says a substance will help to heal symptoms similar to those that it is known to cause. This is the same principle behind immunization.

When I received Lissa's newsletter on homeopathic medicine immediately I thought of how this applies to diabetes - a disease of insulin antibodies attacking the naturally produced insulin in the body. Why would you treat a disease with the exact hormone that caused it? Novo, Lilly, Aventis - you are all making a grave mistake in forcing American's to use GM human insulin, both Type 1 and Type 2. The extinction of porcine and bovine insulin has consequently proven to be detrimental to diabetics over the last 25 years. Studies show tighter control - yet complications on the rise. How do you explain this? I'm not excited for what the future holds, unless we see a return of these similar but not exact insulin forms.

Here we go again. Big Pharma releases a study and spins a tall tale. Big Media falls for it. This fable stars the lead character Byetta, a.k.a. 'byetta not take it.'

Byetta-makers Amylin and Lilly visited the American Diabetes Association's annual meeting and released clinical results from a three-year trial, the lengthiest one to date. The 217 patients with diabetes enrolled in the study had poor blood glucose control with other diabetes drugs metformin or sulfonylurea. Byetta was added to the mix.

Here's the punchline -- after three years, 46 percent of patients were able to maintain blood-glucose levels of a 7.0 A1C (not impressive for a type 2 diabetic) and 30 percent had a 6.5 A1C -- the target level recommended by the ACE Diabetes Mellitus Consensus Conference in 2001. Notice the media reports do not say anything about the remaining 24 percent who obviously had A1C levels higher than 7.0. Add that 24 percent to the 46 percent at the non-optimal level of 7.0 A1C and you get 70 percent of patients maintaining blood sugars high enough over three years to silently develop retinopathy, kidney problems and nerve damage, to name a few.

Thank you to Jenny at the Diabetes Update blog for her June 26 insights on this study. She also has much to say on Byetta's touted weight loss. While one in four patients did lose an average of 29 pounds (impressive), three out of four only lost an average of eleven pounds -- not much weight loss.

Is the injectable type 2 diabetes drug Byetta really 'byetter'? Where do they come up with these names? The drug-naming brainstorm team had an off day. But it appears Byetta does have real benefits.

Research indicates diabetics taking Byetta, combined with metformin, had one-sixth the chance of hypoglycemia compared to those taking insulin and metformin. Byetta-makers Amylin and Lilly released study results at the American Diabetes Association's annual conference.

The study tracked 114 diabetics over two 16-week periods. Diabetics taking Byetta/metformin realized a 2.6 percent chance of a hypoglycemia, while those on insulin/metformin had a 17.4 percent chance. Byetta-takers also lost an average of 5.7 pounds, while insulin-takers gained 1.3 pounds. A bonus, especially for type 2s.

Keep cynically in mind, the study was generated by Big Pharma. Amylin and Lilly split $430 million in Byetta sales last year. Jon LeCroy, an analyst for Natexis Bleichroeder, stated Byetta's lower risk of hypoglycemia and weight gain are already well-known by doctors. He does not believe this new study will increase sales.

The generic name for Byetta is exenatide, a synthetic hormone. In short, exenatide is part of a class of drugs called incretin mimetics, which mimic the effects of incretins. Here's a little chemistry for you -- incretins are hormones released into the blood by the intestines in response to food. One such incretin, GLP-1, lowers blood glucose by three mechanisms: increasing pancreatic insulin secretion, slowing absorption of glucose and reducing the action of glucagon. GLP-1 also acts as an appetite suppressant.

Byetta was approved by the Federal Drug Administration in May of 2005.

Scarborough Research, the leading local market research firm for identifying consumer and retail behaviors in the United States, took the liberty of compiling a list of the top local markets selling diabetic medications in the last 12 months. A dubious distinction it may be, these locations burn like a flame for the moths of diabetes product resellers.

Knoxville, TN, Memphis, TN, and Columbus, OH round out the top 3 local markets for diabetes medication purchasers. The Scarborough analysis also finds that Walgreens is the number one national drug store brand among diabetes medication purchasers. More than 3.1 million, or 18%, of these consumers purchased prescription drugs at Walgreens during the past year. CVS (17%), Wal-Mart (16%), Rite Aid (8%), and Eckerd Drug (4%) complete the top national drug store brands among diabetes medication purchasers.

In Charleston, Wal-Mart is the top store among diabetes medication purchasers, as over one-quarter (27%) of these consumers purchased prescription drugs there during the past year. Rite-Aid (20%), CVS (14%), Fruth Pharmacy (8%), and Kroger (5%) are other leading stores among diabetes medication purchasers.

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.

A study suggests problems with cholesterol regulation in the insulin-producing cells of the pancreas may be responsible for the development of Type 2 diabetes.

A thesis paper written by a graduate student, Dr. Liam Brunham, addressed the fact that a dysfunction in cholesterol regulation is found in beta cells in the pancreas. A thought-provoking connection to this thesis was the fact that beta cells are the cells responsible for producing insulin. A beta cell expert decided to see what would happen if researchers genetically engineered mice without the ABCA1 gene. The ABCA1 gene is the gene responsible for cholesterol regulation in beta cells. Dr. Brunham appears to be the first to identify the role of cholesterol dysfunction resulting in the beta cells inability to properly secrete insulin.

This new research is promising and obviously raises questions in other researcher's minds. One is - what happens when amylin, a hormone produced by the beta cells, builds up to excess amounts? Does this, in fact, impair the beta cells' ability to function properly? Could this be another thesis that trumps Dr. Brunham's hunch for the cause of type 2 diabetes? Some researchers believe that the over-production of amylin and cholesterol may be due to a yet unidentified problem. Of course that is always an option. Science labs across the world could come to a screeching halt if doctor's stopped hypothesizing. As research continues, we will anxiously await the next best thesis paper, courtesy of our promising Graduate Students. Be cool - stay in school!

Neuropeptide regulating appetite may help in developing new diabetes treatments. The neuropeptide called melanin concentrating hormone (MCH) plays a role in the growth of insulin-producing beta cells and the secretion of insulin. MCH is found in the brain and regulates energy balance and appetite.

A previous study conducted at Joslin found an association between high levels of MCH and an increase in the number of beta cells in mice. When we eat food, our body needs more insulin. When MCH induces appetite, it simultaneously increased insulin secretion. This calls upon the beta cells and enhances their growth. If the proteins that mediate the growth mechanism can be identified, it could lead to the development of new drugs that would enhance beta cell growth to treat type 1 and type 2 diabetes.

Sounds great! However, this sounds similar to the function of SYMLIN, which is the synthetic form of amylin. Amylin is a hormone secreted by beta cells at the same time as insulin. If you've heard of Byetta - you've heard of Amylin Pharmaceuticals, the makers of SYMLIN. The researchers at Joslin and the guys at Amylin should get together and do lunch. They might have a lot to discuss between this research and the development of yet another biotechnological blockbuster drug.

The FDA has approved sitagliptin phosphate tablets to improve blood glucose levels in patients with type 2 diabetes. The drug, named Januvia, is proudly presented to the diabetic community by Merck and Co.

JANUVIA, a once-daily pill, enhances your body's natural ability to balance blood sugar levels. Your body sends important messages to your pancreas to try to balance high blood sugar. In response, your pancreas makes more insulin and signals the liver to make less sugar. But a substance in your body called DPP-4 blocks some of these important messages. JANUVIA works by blocking DPP-4, so more of the important messages get through. It also helps your pancreas make more insulin and signal your liver to make less sugar. Another feature of this new drug is the ability to prevent your sugar from going too low. JANUVIA works only when your blood sugar levels are high, or out of balance. When your blood sugar levels are at a healthy balance, JANUVIA doesn't have an effect. Because JANUVIA stops working before your blood sugar gets too low, it is not likely to lower your blood sugar to a potentially dangerous level (hypoglycemia). One more bonus to JANUVIA is the fact that this drug did not show weight gain in most patients during clinical trials.

Could this be the answer for your diabetes dilemma? Next time you swing by your doctor's office, mention that new drug Merck released. I'm sure your doctor will be as thrilled to see your numbers controlled as you'll be to see your natural ability to control them restored. Best of luck to those who find their diabetic solution in JANUVIA!

A Harvard Medical School scientist's experiments with fish discarded along the coast near Boston have led to a new class of diabetes drugs. The latest, from Novartis, may get U.S. approval this week.

In the late 1970s, Habener, a doctor specializing in diabetes care, began buying discarded fish to learn about the ways animals controlled blood sugar. By 1987 Habener discovered a protein in the pancreas of anglerfish that tells the pancreas to produce insulin. He called it glucagon-like peptide-1, or GLP-1. In 1995, researchers uncovered another use for Habener's discovery to treat diabetes. The scientists found an enzyme that digests GLP. By blocking the enzyme, they could increase the body's reserves of GLP, thereby raising insulin levels. Twenty years later, we will soon have the pleasure of meeting Novartis' concept for this chronology of discoveries in the form of liraglutide.

In clinical trials, patients taking liraglutide attained normal blood sugars without the common side effect of weight gain. In fact, liraglutide was more likely to make the patients slightly leaner. Depending on dosage and length of treatment, it may help patients to lose weight. The drug does not cause a change in appetite. Furthermore, none of the liraglutide patients experienced episodes of low blood sugar levels throughout the trials.

I'm no fisherman, but if all the seagulls of Big Pharma are swarming overhead - there's bound to be a school of fish below. However, this school is quite competitive. At last count, the five largest diabetic drug makers are using Habener's findings to create new medicines.

A small molecule has been identified that controls diabetes in mice and may pave the way to the development of easier treatment for adult-onset diabetes.

This key molecule, called Boc5, can stimulate insulin function and reduce body weight by 20%. The molecule stimulates the production of the glucagon-like peptide1 (GLP1), responsible for metabolizing glucose. The study intended to discover ways to sensitize insulin by stimulating production of GLP1. Boc5 is not powerful enough to become a diabetes or weight loss drug. But researchers suggest that similar compounds could join the latest generation of diabetes drugs, called "incretin mimetics." The first FDA-approved incretin mimetic was Byetta. A second such drug, with the generic name liraglutide, is in clinical trials.

The problem with the existing FDA approved incretin mimetic treatments is that they are large molecules that must be administered through injection. Boc5 is a small fry with big potential. Being a smaller molecule gives hope for a new generation in diabetes treatment in the form of a pill many of us would be happy to swallow.

The Food and Drug Administration recently approved Byetta as an add-on therapy to improve blood sugar control in people with type 2 diabetes who have not achieved adequate control on a thiazolidinedione, or TZD.

Byetta is already approved for treatment of patients with type 2 diabetes who are unsuccessful at controlling their blood sugar levels despite using the commonly prescribed oral medications or insulin. Byetta helps control blood glucose in four different ways. First, it signals your pancreas to make the right amount of insulin after you eat. It also stops your liver from making too much glucose when your body does not need it. It may reduce your appetite and the amount of food you eat. And it helps slow down how quickly food and glucose leave the stomach. It's no surprise that back in May, AMYLIN had to increase their production of Byetta, after realizing demand was outpacing the supply.

Byetta has given type 2 diabetics the reassurance they need to take their diabetes control to the next level. Taking your meds no longer has to come with the dubious consequence of a ravenous appetite. And with this new feather in the Byetta cap-the FDA says it does the trick to improve blood sugar control. The jury's out!

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.