FDA OKs New Type 2 Diabetes Drug Tradjenta
May 2, 2011 -- The FDA has approved Tradjenta, a once-daily tablet that helps people with type 2 diabetes control their blood sugar.
Tradjenta (linagliptin) is a DPP-4 inhibitor, in the same drug class as Januvia and Onglyza. While these drugs have the same mechanism of action, DPP-4 inhibitors appear to have significant differences in effect.
"This approval provides another treatment option for the millions of Americans with type 2 diabetes," Mary Parks, MD, director of the FDA's division of metabolism and endocrinology products, says in a news release. "It is effective when used alone or when added to existing treatment regimens."
By blocking a specific chemical messenger in gut cells, Tradjenta stimulates the release of insulin after a meal. This keeps blood sugar levels from skyrocketing while posing little risk of a dangerous drop in blood sugar (hypoglycemia).
The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache. The drug will be sold with an FDA-required "Patient Package" explaining the drug's uses and risks.
Like other DPP-4 inhibitors, Tradjenta can be taken in combination with other diabetes drugs, such as metformin.
Tradjenta is jointly marketed by Boehringer Ingelheim and Lilly.
Slideshow: Diabetes Management in 10 Minutes or Less
Tradjenta (linagliptin) is a DPP-4 inhibitor, in the same drug class as Januvia and Onglyza. While these drugs have the same mechanism of action, DPP-4 inhibitors appear to have significant differences in effect.
"This approval provides another treatment option for the millions of Americans with type 2 diabetes," Mary Parks, MD, director of the FDA's division of metabolism and endocrinology products, says in a news release. "It is effective when used alone or when added to existing treatment regimens."
By blocking a specific chemical messenger in gut cells, Tradjenta stimulates the release of insulin after a meal. This keeps blood sugar levels from skyrocketing while posing little risk of a dangerous drop in blood sugar (hypoglycemia).
The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache. The drug will be sold with an FDA-required "Patient Package" explaining the drug's uses and risks.
Like other DPP-4 inhibitors, Tradjenta can be taken in combination with other diabetes drugs, such as metformin.
Tradjenta is jointly marketed by Boehringer Ingelheim and Lilly.
Slideshow: Diabetes Management in 10 Minutes or Less