This DPP-4 inhibitor was developed by
Eli Lilly and Boehringer Ingelheim and will be marketed under the brand name of
FDA reports that 8 double-blind, placebo-controlled clinical trials in 3,800
subjects demonstrated the drug to be safe and effective in patients with type 2
The drug has been studied as a monotherapy and in
combination with other drugs as well.
Like other DPP-4 inhibitors, linagliptin can be taken
in combination with other diabetes drugs, such as metformin. However,
its use with insulin has yet to be tested
Mary Parks, MD, Director of the FDA's
Division of Metabolism and Endocrinology Products says in a recent news
approval provides another treatment option for the millions of people with type
2 diabetes. It is equally effective when used alone or when added to existing
the release of insulin
after a meal by blocking a specific chemical messenger
in intestinal cells. This keeps blood sugar levels from shooting up while
posing little risk of sudden drop in blood sugar (hypoglycemia).
Clinicians are advised not to
prescribe the drug in patients with type 1 diabetes or those who have diabetic
ketoacidosis. The most common side effects of linagliptin are upper
respiratory infection (URI), sore throat, stuffy or runny nose, headache,
It will be sold with an FDA required
"Patient Package" explaining the drug's uses and risks.