New Medication for Type 2 Diabetes Approved

< Oct. 18, 2006 > -- The US Food and Drug Administration (FDA) has announced the approval of a new medication for the treatment of type 2 diabetes.

Januvia^TM (sitagliptin phosphate) is the first in a new class of diabetes medications to be approved by the FDA. The new class of medications is known as dipeptidyl peptidase-4 (DDP-4) inhibitors. DDP-4 inhibitors help the body's own ability to lower elevated blood sugar.

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), according to the FDA.

In type 2 diabetes, the body either does not produce enough insulin or the body's 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.

Januvia Used With Lifestyle Changes

Januvia is approved to be used in addition to diet and exercise to improve high blood sugar levels among people with type 2 diabetes. The new medication may be prescribed alone or in combination with two other popular diabetes medications, the FDA says.

The other medications that may be used with Januvia are metformin or a peroxisome proliferator-activated receptor gamma (PPAR) agonist such as rosiglitazone maleate (Avandia®) or poiglitazone HCl (Actos®).

Combination drug therapy may be recommended when either metformin or a PPAR inhibitor, along with diet and exercise, does not provide adequate blood sugar control.

Januvia works by aiding proteins that increase the body's supply of insulin after blood sugar rises.

The medication was studied among 2,719 people with type 2 diabetes. Common side effects seen during clinical trials included upper respiratory infection, sore throat, and diarrhea.

Treatment for Type 2 Diabetes

Treatment emphasis for type 2 diabetes is on control of blood sugar (glucose) by monitoring blood glucose levels, regular physical activity, meal planning, and routine healthcare.

Treatment of diabetes is an ongoing process of management and education that includes not only the person with diabetes, but also family members and healthcare professionals.

Often, type 2 diabetes can be controlled through lifestyle changes such as losing weight, improving nutrition, and exercising. However, in some cases, these measures are not enough and either oral medications and/or insulin must be used.

"For the millions of Americans with type 2 diabetes, who continue to have inadequate blood sugar control, the approval of Januvia marks an important advance in the fight against diabetes," says Dr. Steven Galson, Director of the FDA's Center for Drug Evaluation and Research.

"We now have another new option that treats the disease in an entirely new way that can be added to existing treatment regimens to help patients gain more control over their blood sugar levels," Dr. Galson adds. 

Dr. Edward S. Horton, director of clinical research at the Joslin Diabetes Center in Boston, Mass., and professor of medicine at Harvard Medical School, says, "Those patients who are unable to adequately manage their type 2 diabetes with lifestyle changes, like healthy eating and increased physical exercise, and who require medications now have a new product to help regulate their blood sugar levels."

According to the manufacturer of Januvia, Merck and Co., Januvia has not yet been studied in persons under the age of 18; therefore, it is currently intended only for use in adults.

Januvia is not intended for treatment of type 1 diabetes. Persons who take insulin or a type of diabetes medications known as sulfonylureas should not take Januvia because it has not been studied in conjunction with the administration of these medications.

Always consult your physician for more information.

More About Type 2 Diabetes

Type 2 diabetes is a metabolic disorder resulting from the body's inability to make enough insulin or to properly use insulin. It used to be called non-insulin-dependent diabetes mellitus (NIDDM) or adult-onset diabetes.

Without adequate production or utilization of insulin, the body cannot move blood sugar into the cells. Type 2 diabetes is a chronic disease that has no known cure. It is the most common type of diabetes.

According to the National Institute for Diabetes and Digestive and Kidney Disorders (NIDDK) and the American Diabetes Association (ADA):

• Of the 20.8 million Americans with diabetes, 90 percent to 95 percent have type 2 diabetes. Of these, half are unaware they have the disease.

• People with type 2 diabetes often develop the disease after age 45, but are not aware they have diabetes until severe symptoms occur, or they are treated for one of its serious complications.

• Type 2 diabetes is more prevalent among African American, Hispanic/Latino American, and Native Americans.

• Type 2 diabetes is nearing epidemic proportions, due to an increased number of older Americans, and a greater prevalence of obesity and a sedentary lifestyle.

The exact cause of type 2 diabetes is unknown. However, there does appear to be a genetic factor which causes it to run in families. And, although a person can inherit a tendency to develop type 2 diabetes, it usually takes another factor, such as obesity, to bring on the disease.

Type 2 diabetes may be prevented or delayed by following a program to eliminate or reduce risk factors - particularly losing weight and increasing exercise. Information gathered by the Diabetes Prevention Program, sponsored by the National Institutes of Health (NIH) and the ADA, continues to study this possibility.

Always consult your physician for more information.