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!

Details are emerging from today's advisory committee meeting on Glaxo's Avandia. First up was a presentation by Dr. Robert Ratner of Washington's MedStar Research Institute outlining the unprecedented spread of type 2 diabetes. Ratner emphasized the inadequacy of current drug therapies for diabetes and the strain on the health system caused by the disease. The possible implication: Avandia does more good than harm right now, so let's keep it as an option.

Next, in written preview comments, an official from the US Food and Drug Administration stated his belief that the diabetes drug should be taken off the market. The official, Dr. David Graham, says the heart risks posed by Avandia mean it's just not worth the risk to patients. Especially, he said, not when there are safer alternatives like Actos (by Takeda), which also stabilizes blood sugar levels.

It's a significant step that someone from the FDA publicly made this statement. But will anything come of it? Maybe not. The decision about whether or not Avandia stays on the market is not up to Dr. Graham, who The New York Times reports has a history of coming down harder on drug risks than many colleagues. (Give the guy a medal!) Thing is: there appear to be plenty of other officials within the FDA who don't agree with Graham's interpretation.

The beleaguered US Food and Drug Administration (FDA) today released its review of the Avandia debacle. It contains a fairly damning assessment of what went wrong, one that implicates not only Avandia's manufacturer GlaxoSmithKline, but also the FDA itself.

The 436-page review confirms that Avandia does indeed increase the risk of heart problems, a claim that Glaxo has vigorously denied. (Can't wait to see how they respond to this.) The FDA reviewers concluded that the risk is also far greater than that posed by a similar drug, Actos, which is manufactured by Takeda. In addition, the FDA reviewers were dismissive of the studies conducted by Glaxo - studies that the drugmaker claimed provided proof of Avandia's safety. The report also restates the allegation that Glaxo tried to coerce a doctor into remaining silent about the risks posed to diabetics from taking Avandia.

The report goes on to find fault with the FDA's inaction and, by implication, its completely pathetic pandering to Glaxo. Now, even insiders are publicly saying FDA officials repeatedly put the interests of Glaxo above the interests, health and safety of consumers.

All-in-all, this represents a big victory for Glaxo/BigPharma's critics. It almost goes without saying that this report likely marks the end of the line for Avandia. Perhaps more significant could be the impact of the whole mess on the FDA. The review effectively highlights the shortcomings of the agency for all to see, greatly strengthening the hand of its critics - both in and outside government - who are calling for major reforms there.

Click here to read more.

Stay tuned for news of the advisory committee hearing on Avandia, which is scheduled to be held Monday.

British-based website Scientist Live reports on a possible link between cancer and the use of thiazolidinediones (TZDs), a class of medications used to treat diabetes. The link comes from the Vermont Diabetes Information System, which enrolled just over one thousand participants in a study that relied on self-reported patient information and lab-verified data. The authors of the study assert that the link between TZD use and increased incidence of cancer is significant even after correcting data to allow for the influence of other factors such as smoking, body mass index, and other drugs being taken by the patients.

A little background: TZDs are prescribed because they lower blood sugar levels. They work by lowering insulin resistance, making the body better able to respond to insulin without actually causing an increase in insulin production. Brand name examples of TZDs include Actos, Avandia and Metformin. A type of TZD medication was banned in Europe after it was found to cause severe liver damage. According to the Wikipedia entry on TZDs, these substances are being investigated as potential treatments for a handful of other medical problems, but are currently used just for diabetes.

If there is indeed a link between TZD usage and increased cancer risk, we really need to find out ASAP. These drugs are prescribed to treat a chronic condition, so once you're on one you're likely to stay on it long-term. Who wants to be exposed to that on top of all the other possible side-effect risks? Stay tuned.

Avandia, a drug used to treat Type 2 diabetes, has been in the news of late following the release of controversial study results which concluded the drug leaves patients at an increased risk for heart trouble. My fellow blogger Bev has touched on the conundrum now facing diabetics on Avandia regimens. You can quit taking Avandia, but then what? Thousands of Americans are now facing this predicament and many have opted to switch their prescriptions to something else. The Philadelphia Inquirer is running a feature about this and talks to some diabetics who have opted for the "try something else" route.

The Inquirer profiles, among others, pharmacist Ben Briggs, 59, who switched to Merck's Januvia in the wake of the Avandia scandal, but was sorely disappointed in the results. Instead of seeing an improvement in his blood sugar levels, his health actually declined rather rapidly: he gained eight pounds and said he was "feeling awful." He promptly ditched that drug too and is now on yet another medication. According to diabetes experts interviewed by The Inquirer, patients should "tread carefully" and avoid rushing to switch to drugs such as Januvia, which do not have the proven track records of the old standbys insulin and metformin.

Bottom line: this whole dust-up over Avandia is a nightmare for its producer, GlaxoSmithKline. However, its competitors Merck and Takeda Pharmaceutical could stand to make a bundle as diabetics switch in droves from Avandia to Januvia or Takeda's Actos. According to Deutsche Bank analyst Barbara Ryan, sales of Januvia alone could be up as much as $300 million annually as a result of Avandia's troubles, while Actos profits could rise even higher than that. You have to imagine Merck and Takeda must be nervously making hay while the sun shines, hoping they don't end up testifying to Congress some day in the future.

Call the art director and the printer. It's time for a label redesign.

Glaxo just finished revving up the printing press for their aggressive PR campaign assuring us all Avandia is safe. Yesterday, the FDA ordered Glaxo to add their strictest warning to bottles of Avandia -- the dreaded black box label. They also ordered the black box label be placed on Avandia's closest competitor, Actos, manufactured by Takeda Pharmaceuticals and Eli Lilly & Company.

This bomb was dropped by FDA commissioner, Dr. Andrew C. von Eschenbach, in the midst of a packed House hearing investigating the FDA's questionable handling of Avandia. In a written statement, he said the agency asked Avandia and Actos makers to add the more prominent black box warning of heart failure because the drugs were being prescribed to patients with significant heart failure, despite existing warnings on the bottle. Dr. Nissen's May 21 study, which sparked the controversy, revealed a 43 percent higher risk of a different side effect, heart attack.

Revealed to the public only yesterday, turns out the FDA had requested drug makers for the black box label on May 23, a mere two days following publication of Dr. Nissen's study in the New England Medical Journal.

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 new survey reveals that most people prefer to treat diabetes by changing their diets, rather than using medicines.

According to a survey of 1,022 adults (515 women and 507 men), 69% of Americans would prefer to try a dietary approach, whereas only 21% preferred treating diabetes with medicines. The survey reinforces results from clinical research on diabetes, which has consistently found that people with diabetes adapt well to low-fat vegetarian diets and gain important health benefits. A dietary approach to diabetes based on scientific research shows that a low-fat vegan diet can lower high blood sugar levels three times more effectively than oral medications.

Among the results: women are even more likely than men to prefer food changes over pills. People with more education and higher incomes were especially likely to favor a diet approach. For the financially savvy - this makes a lot of sense. You MUST buy food. You might as well buy healthier foods and curtail your Rx costs. Furthermore, Americans aged 45 to 64 were more enthusiastic about diet changes, compared with older Americans. I'll bet it's the convenience factor. A little less medication, a little more supper, please. The most pill-happy generation was the 18- to 24-year-olds. Don't look at me like that - I'm 28 and favor the flavor over medication, any day. Bon appetit!

Metabolex is a company dedicated to the discovery and development of novel therapeutics for diabetes and related metabolic disorders. They recently announced the launch of a double-blind, placebo-controlled Phase 2a, proof-of-concept study for MBX-2044, an oral insulin sensitizer for the treatment of type 2 diabetes.

Metaglidasen and MBX-2044 address insulin resistance, the underlying cause of type 2 diabetes, by enhancing insulin sensitization. The currently marketed insulin sensitizers, Actos® and Avandia®, carry warnings of increased risk of congestive heart failure due to edema and cause significant weight gain, which compromises patient compliance.

Metaglidasen and MBX-2044 have been specifically designed to address the shortcomings of the currently marketed insulin sensitizer drugs. Clinical testing of metaglidasen suggests it has comparable efficacy with an improved safety profile. Now we're getting somewhere with this medical advancement stuff! A new drug that does the trick sans the undesirable side effects - attaboy, Metabolex!

According to a new study published in the New England Journalism of Medicine, the diabetes drug Actos may help prevent serious complications from nonalcoholic fatty liver disease. The disorder is primarily caused by being overweight. Insulin resistance, diabetes and high levels of cholesterol all contribute to the development of nonalcoholic fatty liver disease and its complications.

The study included candidates with either insulin resistance or type 2 diabetes. About half of the group took 45 milligrams of pioglitazone (brand name Actos, manufactured by Takeda Pharmaceuticals) daily for six months, while the other half took a placebo. Both groups were asked to maintain a lower calorie diet. The group taking pioglitazone saw a decrease in their levels of abnormal liver enzymes and a 54 percent reduction in liver fat, compared to the placebo group. Insulin sensitivity in the liver improved by 48 percent in the pioglitazone group, as compared to only 14 percent in the placebo group.

Current treatment for nonalcoholic fatty liver disease is aimed at lifestyle changes, such as losing weight and exercising regularly. Pioglitazone offers a resolution to improve the metabolism of blood glucose, and decreases cholesterol. Researchers were especially excited by the findings of this study because there is now a pharmacological option that might help prevent end-stage liver disease.

A new once-daily diabetes pill is about to enter the US market. The US Food and Drug Administration has approved the release of Duetact, a drug that combines Actos and Amaryl into one pill. Duetact should be available for purchase later in the year, according to manufacturer Takeda Pharmaceuticals North America.

The pills will be available in varying dosages, but all offer the benefits of taking both drugs at one time. The two drugs both help to lower blood sugar levels, but they work in different ways. (Actos improves insulin resistance, while Amaryl increases insulin production.) According to Takeda, there are possible adverse side-effects to consider when taking Duetact, including low blood sugar, weight gain and heart problems.

Drug manufacturer Novartis claims that combining its new drug Galvus with another drug called Actos is so effective it will postpone diabetic patients' need for insulin. Galvus (vildagliptin) is designed to reduce high blood sugar levels and comes in the form of a pill, taken once a day. Novartis says that taking Galvus along with a dose of Takeda's Actos reduces blood sugar levels by an average of 1.9 percent. The company also says the combo is even more effective for people with very high blood sugar levels.

Galvus is one of the new so-called blockbuster diabetes drugs that are expected to earn big bucks for their manufacturers. Novartis will pit Galvus against Merck's Januvia, which works in a similar way to Galvus. Galvus has received a lot of media hype because Novartis says it not only stabilizes blood sugar levels, but that it does so in a way that does not cause weight gain, a common and dreaded side-effect of some diabetes meds.