The FDA has approved a supplemental new drug application for Tradjenta (linagliptin, Boehringer Ingelheim Pharmaceuticals/Eli Lilly) tablets for use as add-on therapy to insulin.
Tradjenta is a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes, such as metformin, sulfonylurea, pioglitazone or insulin. Tradjenta should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
The FDA's decision is based on data from a 52-week, phase 3 trial demonstrating the efficacy of Tradjenta in combination with insulin (with or without metformin and/or pioglitazone). 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).
Also, the new FDA-approved label includes a clinical study in people with severe chronic renal impairment.
Tradjenta seeks to lower blood sugar in a glucose-dependent manner by increasing incretin levels, which increase insulin levels after meals and throughout the day. With Tradjenta, no dose adjustment is required regardless of declining renal function or hepatic impairment, according to the Indianapolis-based Eli Lilly and the Ridgefield, Conn.-based Boehringer.