There are two types of diabetes. Type 1 occurs when the body doesn't produce any insulin. People with type 2 diabetes either don't produce enough insulin or their cells ignore the insulin. Nearly 95% of people with diabetes have type 2.
Before people get type 2 diabetes, they usually go through a prediabetic stage in which they have what is called impaired fasting glucose (IFG). In people who have IFG, blood sugar levels are higher than normal but not high enough to say they have diabetes. People who have IFG have a high risk of getting diabetes. They also are more likely to have a heart attack.
Some people who have type 2 diabetes need to take insulin in shots to help control their blood sugar levels. Most take pills by mouth (oral medicine) to help control their diabetes. People who take insulin may also need to take 1 or more of these oral medicines.
Most recently,the Food and Drug Administration (FDA) announced the approval of Januvia (sitagliptin phosphate) Tablets, the first diabetes treatment approved in a new class of drugs known as DPP-4 inhibitors that enhances the body's own ability to lower elevated blood sugar.
FDA approved Januvia for use in addition to diet and exercise to improve blood sugar levels in patients with type 2 diabetes, alone or in combination with two other commonly prescribed oral diabetes medications, metformin or a PPAR (peroxisome proliferator-activated receptor gamma) agonist, when either of these drugs alone, along with diet and exercise, don't provide adequate blood sugar control.
More than 20 million people in the United States have type 2 diabetes, the most common form of the disease. People with this condition either don't produce enough insulin, or cells in the body don't utilize the hormone efficiently. Insulin is essential for transporting sugar from the blood to cells for energy. If sugar isn't cleared from the bloodstream, it can eventually lead to potentially fatal complications such as heart disease, nerve damage, kidney damage, blindness and amputations. The number of Americans with type 2 diabetes is expected to continue to climb due to the obesity epidemic.
Type 2 diabetes is the most common form of the disease, accounting for about 90 percent to 95 percent of all diagnosed cases of diabetes (20.8 million in 2005). In type 2 diabetes, the body does not produce enough insulin or the cells ignore the insulin. Insulin is necessary to take sugar, the basic fuel for cells, from the blood into the cells. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, nerve damage, and kidney damage.
Recently,the U.S. Food and Drug Administration announced the approval of Januvia (sitagliptin phosphate) oral tablets, the first in a new class of drugs known as DPP-4 inhibitors.
"These DPP-4 inhibitors act to enhance the body's own ability to release insulin and thereby decrease elevations in blood sugar," said Dr. Robert Meyer, director of the Office of Drug Evaluation II in the Office of New Drugs at the FDA Center for Drug Evaluation and Research. "Type 2 diabetes is very, very common and, despite the numerous therapies already available, many people do not adequately control their blood sugar. A new option in type 2 diabetes, particularly one in a new class, is always a useful addition to therapies for diabetes."
Januvia is approved for use by people with type 2 diabetes that can't be controlled adequately with diet and exercise. It can be used either by itself or in combination with two other commonly prescribed oral medications for type 2 diabetes, metformin (Glucophage and other brand names) or a peroxisome proliferator-activated receptor gamma agonist (PPAR) such as Actos or Avandia.
Januvia, made by Merck & Co., blocks the activity of an enzyme (dipeptidyl peptidase IV, or DPP-4, that breaks down the proteins that increase the release of insulin. This gives the proteins more time to work, thereby enhancing blood-sugar control.
While Januvia is the first in this new class of drugs, other medicines are in the pipeline, including one from Novartis AG that may win approval later this year. Merck is also seeking approval for another pill, MK-0431, that would combine Januvia and metformin.
Januvia was studied in 2,719 patients with type 2 diabetes, with follow-ups of 12 weeks to more than a year. It lowered blood sugar levels by 0.67 percent for participants in a yearlong trial, or just as much as another, older drug, glipizide. Novartis' pill, Galvus (vildagliptin), reduced blood sugar levels by 1.9 percent when used with another older drug, pioglitazone, which reduces insulin resistance.
Merck is expected to charge $4.86 for the pills, which are taken once-a-day. Older diabetes drugs can cost as little as 50 cents a day, according to published reports.
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