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...)

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.

Novartis SA reports the U.S. FDA has demanded additional data, including a clinical study in patients with kidney impairment, before giving Galvus its approval. Why the holdup?

The FDA wants more data studying Galvus in patients with impaired kidneys. It had been thought that Galvus might have an advantage because it is not processed by the kidneys, while Januvia is. But another molecule created when the body metabolizes Galvus does build up in the kidney.

In the Feb. 1 issue of The New England Journal of Medicine, David M. Nathan, a Harvard Medical School endocrinologist, noted that it was surprising that the FDA decided to clear Januvia at all, given the "paucity of published data from long-term clinical trials on its safety and efficacy." Nathan is a consultant for Novartis and other drug makers but not Merck.

There are several potential concerns about DPP-4 drugs, clear evidence has not turned up in clinical trials so far. The medicines could affect the immune system, because a receptor on immune cells is very similar to DPP-4. Merck says that Januvia was designed to bind only to the DPP-4 enzyme, reducing the chances of these side effects. Patients with impaired kidneys have more of the drug in their bloodstream and would be more likely to experience side effects.

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!

In the $20 billion diabetes market, when drugs make their way onto the scene, it's a head-turning event. So far, one drug is gaining ground and two of them are raising interest.

Januvia, manufactured by Merck, was recently approved for the treatment of diabetes. Januvia is used with diet and exercise to lower blood sugar in patients with type 2 diabetes. Januvia lowers blood sugar when blood sugar is high, especially after a meal. It also lowers blood sugar between meals and helps to improve the levels of insulin produced by your own body after a meal. The drug is unlikely to cause your blood sugar to be lowered to a dangerous level because it does not work when your blood sugar is low. Januvia faces potential competition from an experimental drug, Galvus. The drugs are similar in many respects, including their status as once-a-day pills, and their ability to lower blood-sugar levels in diabetics while helping them to lose weight, or at least to avoid gaining it. The FDA delayed its decision on Galvus, so we may be waiting till the first half of 2007 to see it in action.

Acomplia, manufactured by Sanofi-Aventis, is in hot pursuit of FDA approval. Acomplia is primarily a treatment for diabetics, but the drug is unusually multi-faceted. It was created to help people quit smoking and lose fat by blocking circuitry in the brain that gives the body cravings. The drug works by blocking the same circuitry in the brain that gives pot-smokers the munchies. The drug is expected to receive FDA approval in the first half of 2007.

On Tuesday, October 17, the clouds parted and the medicinal gatekeepers welcomed the birth of a little bundle of joy from Merck & Co, named Januvia. Weighing in at $4.86 per tablet, and guaranteed to control blood sugars without the undesirable side effect of weight gain, Merck said Januvia would be in pharmacies in the near future.

This is a new class of pills called DPP-4, or dipeptidyl peptidase IV. These are inhibitors that work to enhance the body's own ability to lower blood sugar. In clinical trials, patients did not gain weight. Yippee! Taken once a day, Januvia is expected to face competition from Novartis AG's rival medicine Galvus, which is awaiting FDA approval, possibly next month. The first generation of drugs designed to combat insulin resistance notoriously caused water retention and gain weight.

The empirical evidence is shining through already. A survey of about 60 physicians, conducted by Reuters Primary Research, shows the vast majority of doctors intend to start prescribing Januvia and Galvus right away. Dr. Stuart Weiss, a New York University Medical Center endocrinologist, said the drug's ability to control blood sugar spikes without added weight gain was a big draw. "In the face of a diabetes epidemic, this drug ... is particularly an inviting choice," said Weiss, who has consulted for several Merck competitors, including Novartis. If the near $5 a day price tag doesn't send your budget into a tailspin, you might have the shelf space for a DPP-4 in your near future. Praise be the DPP, for the sugars will come down and the scales won't creep up!

My previous blog was about the meeting now underway in Copenhagen of the European Association for the Study of Diabetes (EASD). More significant news from that meeting: Galvus, the diabetes drug manufactured by Novartis, appears to work as well as GlaxoSmithKline's Avandia - but without the nasty side effects.

Galvus and Avandia are both designed to lower blood sugar levels. However, in the case of Galvus, this is achieved without causing weight gain and with less incidence of fluid retention, which is seen with Avandia. This is all good news for patients, said Emanuele Bosi of Milan's San Raffaele University, while addressing the EASD meeting. Remarked Bosi, neither patients nor their physicians should accept side effects of diabetes meds as a normal part of treatment. Great - who could disagree with that?

Naturally, this represents a major coup for Novartis in the unrelenting battle for dominance of the diabetes drug market. On the other hand, Novartis is not home free: Januvia, which works in the same way as Galvus and is manufactured by Merck & Co., should also reach markets soon enough too.

Don't call your doctor just yet though. Galvus is not yet approved for sale in the United States.

There's a report in The New York Times today about the growing market for diabetes drugs--and how that market grows as the so-called diabetes epidemic escalates. The article also touches on the positive spin-off in terms of money-making possibilities for the drug companies and their investors. (The market for diabetes drugs is now worth an estimated $15 billion, and that is expected to grow to at least $25 billion worldwide by 2001!)

The article is worth a look because it profiles the four diabetes-fighting drugs that are generating the most excitement these days. They are: 1. Byetta, 2. Exubera, 3. Galvus, and 4. Januvia. Byetta (pictured) is already available and comes in the form of an injection. Exubera is an inhalable insulin delivery device that will be released for sale in the US in July. Galvus and Januvia come in the form of pills and are expected to arrive on the market next year.

The reason there is so much excitement surrounding these drugs is that they are relatively hassle- and pain-free to use and, best of all, they help treat the underlying causes of diabetes. Anyway, this article gives a handy overview of what all the fuss is about - check it out!

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.

In a new report from CNN, it's being predicted that drug companies Merck and Novartis are about to "lock horns." That is, they're both developing two similar diabetes drugs, both of which have the potential to have a groundbreaking impact on the market. In addition, both these drugs are now under review by the US Food and Drug Administration. The result? Analysts are saying these giant companies could be drawn into a fight for dominance of the diabetes drug market.

Merck is the second biggest drug manufacturer in the US, and is developing the drug Januvia. The Swiss company Novartis has been making great inroads into the US market in recent years, and hopes to introduce a similar drug called Galvus. Both drugs are designed to lower blood sugar in Type 2 diabetics. Says market analyst Jon LeCroy, "You really have two products battling it out. The question is: who's the winner and who's taking second share?"