The FDA ( Food and Drug Administration ) has approved Januvia ( Sitagliptin ), 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 glucose.

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 glucose control.

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 ).
Over time, high blood glucose levels can increase the risk for serious complications, including heart disease, blindness, nerve damage, and kidney damage.

Januvia prolongs the activity of proteins that increase the release of insulin after blood glucose rises, such as after a meal. Januvia does this by blocking an enzyme ( dipeptidyl peptidase IV or DPP-IV ) which breaks down these proteins, leading to better blood glucose control.

Januvia was examined in a total of 2,719 patients with type 2 diabetes, in studies lasting from 12 weeks to more than a year. These studies demonstrated improved blood sugar control when Januvia was used alone or in patients not satisfactorily managed with metformin or a PPAR agonist.

The most common side effects in clinical studies were upper respiratory tract infection, sore throat, and diarrhea.

Source: FDA, 2006


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