FDA Approves New Drug for Type 2 Diabetes

May 02, 2011

May 2, 2011 — The US Food and Drug Administration (FDA) today approved linagliptin (Tradjenta, Eli Lilly Co and Boehringer Ingelheim Pharmaceuticals) for improving blood glucose control in adults with type 2 diabetes, either as a stand-alone or in combination with other therapies.


Linagliptin, which comes in tablet form, boosts the level of hormones that stimulate the release of insulin after a meal by blocking an enzyme called dipeptidyl peptidase-4.

The FDA stated that 8 double-blind, placebo-controlled clinical trials demonstrated that the drug is safe and effective in patients with type 2 diabetes. It has been studied as a stand-alone treatment and in combination with other type 2 diabetes therapies, such as metformin, glimepiride (Amaryl, Accord Healthcare), and pioglitazone (Actos, Takeda Pharmaceuticals). However, the combination of linagliptin and insulin has not been studied.

Clinicians should not prescribe linagliptin for patients with type 1 diabetes or those who have diabetic ketoacidosis. The drug's most common adverse effects are upper respiratory tract infection, stuffy or runny nose, sore throat, muscle pain, and headache.

Linagliptin was discovered by Boehringer Ingelheim, based in Ingelheim, Germany. In January, Boehringer Ingelheim and Eli Lilly announced that they would jointly market the medication.

More information on linagliptin is available at the FDA Web site.