Eli Lilly, Boehringer Ingelheim’s Tradjenta garners expanded FDA approval for use with insulin

Eli Lilly and Boehringer Ingelheim on Friday announced that the FDA expanded approval of Tradjenta (linagliptin) as an add-on therapy to insulin in adults with type 2 diabetes. John Smith, senior vice president for clinical development and medical affairs at Boehringer Ingelheim, noted that "many people with type 2 diabetes taking insulin also require additional medication," and that the DPP-4 inhibitor can "be an effective add-on therapy with a demonstrated safety profile to help adult patients on insulin to improve their [glucose] control."

The decision was based on data from a Phase III trial evaluating Tradjenta in combination with insulin, when used with or without metformin and/or pioglitazone. The study enrolled 1261 patients with type 2 diabetes inadequately controlled on insulin glargine, insulin detemir, or NPH insulin. Results showed that adding Tradjenta to insulin produced better glucose control than insulin alone, with similar incidence of hypoglycaemia between the two groups.

Findings from a second trial involving 133 patients with type 2 diabetes who also suffered from severe chronic renal impairment demonstrated that Tradjenta provided statistically significant improvement in glycated haemoglobin, compared with placebo, the companies said.

The drug was approved in May 2011 as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes, such as metformin, sulphonylurea, pioglitazone or insulin.

To read more Top Story articles, click here.