Tradjenta (linagliptin) tablets, combined with diet and exercise, 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.
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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 percent 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.