People with type 2 diabetes do not produce the pancreatic hormone insulin, or do not properly respond to it. Insulin helps control the levels of sugar (glucose) in the blood of a person. People with too much sugar in the blood to are the risks of serious complications, including heart disease, blindness, kidney damage and nerve damage, the FDA said in a press release.
Type 2 diabetes is the most common form of the disease, affecting up to 95 per cent approximately 24 million people with diabetes to the United States, the FDA said.
Tradjenta stimulates hormones that stimulate insulin release after a person eats. The drug was evaluated in clinical trials involving 3 800 people with diabetes type 2. The most commonly reported side effects included upper respiratory tract infection, nasal congestion, sore throat, muscle aches and headaches.
Tradjenta should not be used by people with type 1 diabetes or those who have levels above normal of ketones in the blood or urine, the Agency informed.
The drug is co-marketed by Boehringer Ingelheim products pharmaceuticals of Ridgefield, Connecticut and based in Indianapolis Eli Lilly and Co.
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