The new type 2 diabetes drug Tradjenta (linagliptin) is now available by prescription in pharmacies across the United States including Walgreens, CVS, Rite Aid following the U.S. Food and Drug Administration (FDA) approval of the drug on May 2, 2011. Tradjenta was approved as a prescription medication to be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Tradjenta should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.
Tradjenta belongs to a class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors and is the first member of its class to be approved at one dosage strength (5 mg, once daily).
Tradjenta was approved based on a clinical trial program that included approximately 4,000 adults with type 2 diabetes. Included in the program were placebo-controlled studies evaluating Tradjenta as monotherapy and in combination with some commonly prescribed medications for type 2 diabetes — metformin, sulfonylurea or pioglitazone.