Tradjenta Approved for Type 2 Diabetes
Tradjenta (linagliptin) tablets, combined with diet andexercise, has been approved by the U.S. Food and Drug Administration to control blood sugar in people with type 2 diabetes, the agency said Monday.
People with type 2 diabetes don't produce the pancreatic hormone insulin, or don't respond to it properly. Insulin helps control the levels of sugar (glucose) in a person's blood. People with too much blood sugar at are risk of serious complications including heart disease, blindness, kidney damage, and nerve damage, the FDA said in a news release.
Type 2 diabetes is the disease's most common form, affecting up to 95% of the estimated 24 million people with diabetes in the United States, the FDA said.
Tradjenta boosts hormones that stimulate the release of insulin after a person eats. The drug was evaluated in clinical trials involving 3,800 people with type 2 diabetes. The most common adverse reactions reported included upper respiratory infection, stuffy nose, sore throat, muscle pain and headache.
Tradjenta should not be used by people with type 1 diabetes or by those who have above-normal levels of ketones in their blood or urine, the agency advised.
The drug is co-marketed by Ridgefield, Conn.-based Boehringer Ingelheim Pharmaceuticals and Indianapolis-based Eli Lilly and Co.
-- Scott Roberts