Januvia

Evidently lots of research is being done for people with diabetes type 2. Januvia sounds like an ideal medication. The following article describes it, and also mentions several other new medications on the horizon.

I'm putting the article in the blog just because I want to keep it and maybe discuss it with my Doctor, except my last HbA1C test was so normal that I probably don't need it anyway. I don't think it has much interest for anyone else but me.

Januvia targets the pancreas but I didn't see any reference in the article to pancreatic side effects.

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The Food and Drug Administration yesterday approved a novel once-a-day pill to treat Type 2 diabetes that lowers blood sugar levels without causing weight gain. The FDA said the drug, called Januvia, is ``important" because 70 percent of diabetes patients cannot adequately control their blood sugar using existing treatments.

Januvia is expected to become a billion-dollar blockbuster treatment for its maker, Merck & Co., and will be priced at $4.86 per tablet. Newly diagnosed patients can use the drug on its own, along with diet and exercise, to control blood sugar levels. And because it doesn't cause severe side effects when used in combination with popular diabetes drugs already on the market, Januvia also can be used by those whose disease is more advanced and requires more medicines.

The drug leverages the body's natural ability to control blood sugar by producing more insulin and lowering glucose. Controlling blood sugar can help stave off the need for patients to take insulin.

Diabetes affects about 21 million Americans and occurs when the body builds resistance to insulin needed to break down food, causing blood sugar levels to spike.

About 95 percent of adults with diabetes have the Type 2 form. They either do not produce enough insulin or their bodies fail to use what is produced. Those with Type 1 diabetes must take insulin daily because their bodies do not produce any insulin.

Unchecked diabetes can cause blindness , kidney failure , and heart ailments and can lead to amputations . The number of people with it is rising because of expanding waistlines and sedentary lifestyles, according to the National Institutes of Health.

In clinical trials, Januvia did not have the side effects typical of older treatments, such as weight gain, and dangerous drops in blood sugar. The most commonly reported side effects in trials have been minor: runny noses, coughs, colds, sore throats, diarrhea and nausea. But some in the medical community fear that could change when millions begin to use the new drug.

Analysts and physicians said Januvia offers a ``modest" reduction in a key measurement to gauge how well a patient's blood sugar level is being controlled. Elevated values increase the risk for eye , kidney , nerve, and heart damage.

A Boston man with Type 2 diabetes who has responded well to metformin, a generic treatment for diabetes, said he would use Januvia even if it only slightly improved his blood sugar value.

``I look at it as almost like a scale," said Marc Onigman , 56 . ``If the drug can help me keep that number dead-even, bring on the drug. As long as it doesn't have side effects that lay me out for a week."

Januvia boosts insulin levels when blood sugar levels are high, but cuts off the supply ``when the blood sugar goes down to normal," said Dr. Edward Horton , director of clinical research at the Joslin Diabetes Center in Boston . ``It's taking advantage of the body's own mechanism to respond to a meal."

Because Januvia helps the body better manage insulin levels, he said, it is much less likely to cause hypoglycemia -- dangerously low blood sugar levels -- than older treatments.

Horton, a Harvard Medical School professor of medicine , is a paid Merck consultant. The company has made him available for interviews about Januvia and has sponsored diabetes treatment sessions for doctors featuring him as a speaker.

Januvia targets an enzyme that is involved in activating many of the body's hormones, which worries some doctors because studies of how it affects patients have been limited. FDA approval was based on studies involving 2,719 patients. Roughly 440 of them had taken Januvia longer than one year and only 160 had taken the drug for two years.

``The concern always has been that the regulation of some of those hormones may be very important in subsets of patients that we don't yet understand," said Dr. John Buse , director of the Diabetes Care Center at the University of North Carolina-Chapel Hill and president-elect of the American Diabetes Association . Because Januvia is the first drug approved in its class, it is not surprising that some people will approach it with caution, Buse said.

``There are many patients and, maybe, even more doctors who are relatively reluctant to use a new drug in the first six months or year after it's released," he said.

Merck said it will conduct additional tests of Januvia in combination with insulin and another class of diabetes drugs.

``Type 2 diabetics use a variety of medications to control their condition," said Dr. Mary Parks , the director of the FDA's division of metabolism and endocrine products . ``We want as much information" on the effectiveness and safety of Januvia taken in combination with other products, Parks said.

Some 400 different treatments for diabetes are in development. Recent innovations include inhaled insulin, which eliminates the need for injections.

Deutsche Bank research analyst Barbara Ryan , in a note to investors, called diabetes treatments ``hot, hot, hot" with a market size capable of supporting ``multiple new blockbuster opportunities."

Novartis AG is hot on the heels of Januvia with its own new-generation diabetes pill, Galvus , expected to receive FDA approval next month .

By shipping Januvia quickly, Merck aims to take advantage of ``a short window before Galvus gets the green light," Morgan Stanley analyst Jami Rubin wrote in a research note. Rubin forecasts $350 million in Januvia sales worldwide in 2007 with $1.6 billion in sales by 2010 , a conservative estimate.

A Reuters survey of 60 physicians found ``the vast majority" intend to prescribe Januvia and Galvus immediately.