Linagliptin, Boehringer Ingelheim Pharmaceuticals and Eli Lilly’s 5 mg drug used to treat type 2 diabetes, has received approval from the European Commission. The drug, marketed as Tradjenta, is approved for use in combination with metformin and metformin plus sulfonylurea.
Additionally, the drug is approved as a monotherapy for patients with inadequately controlled diet and exercise and for those who are unable to tolerate metformin.
The drug was approved for use in the U.S. in May. The companies urged that the drug not be used in type 1 diabetic patients to treat diabetic ketoacidosis. The drug also has been approved in other countries such as Japan under the trade name Trazenta, according to the Ridgefield, Conn.-based Boehringer and Indianapolis-based Eli Lilly.
Previous clinical trials have shown linagliptin to reduce hemoglobin A1c levels by nearly 0.6 percent to 0.7 percent compared to placebo. The European approval was based on a clinical trial that enrolled 6,000 type 2 diabetics who received either linagliptin or placebo. Adverse events were similar in patients treated with placebo and the drug, 53.8 percent vs. 55 percent, respectively.
"Linagliptin is primarily excreted unmetabolized via bile and gut, meaning no dose adjustment is needed in adult patients with kidney or liver impairment," said Anthony Barnett, PhD, professor of medicine and clinical director of the department of diabetes and endocrinology, Heart of England NHS Foundation Trust, Birmingham, U.K. "This means that linagliptin is available at only one dose."