The labelling for Boehringer Ingelheim and Eli Lilly's DPP-4 inhibitor Tradjenta has been updated in the US to include the drug's use as an add-on to insulin therapy in diabetes.
The approval is based on a phase III trial of Tradjenta (linagliptin) given in combination with insulin - with or without metformin and/or pioglitazone - in patients with type 2 diabetes.
The year-long study showed that patients on Tradjenta plus insulin had improved blood glucose control than those on insulin alone, and that adding Boehringer and Lilly's drug did not increase the risk of low blood sugar episodes (hypoglycaemia).
The two companies also provided data from a study in patients with renal impairment to check if the combination was safe for use in patients with reduced kidney function - a common complication of later-stage diabetes - and found no cause for concern.
John Smith, senior vice president for clinical development and medical affairs at Boehringer, said that many people with type 2 diabetes who are initially treated with oral drugs eventually go on to require insulin therapy as well.
"Tradjenta can be an effective add-on therapy with a demonstrated safety profile to help adult patients on insulin to improve their blood sugar control," he added, noting that Tradjenta is the only once-daily, one-dose drug in the DPP-4 inhibitor class which does not need dose adjustment in cases of declining renal function or liver impairment.
Tradjenta - known as Trajenta in Europe - was approved in the US in 2011 to improve glycaemic control in adults with type 2 diabetes, with a line extension called Jentadueto (linagliptin plus metformin) given a green light earlier this year.
The DPP-4 inhibitors are an important treatment option in the $16.9bn US diabetes market, thanks to their reduced tendency to cause weight gain compared to older oral antidiabetic agents.
Tradjenta was the third DPP-4 inhibitor to reach the market as a monotherapy in the US after Merck & Co's Januvia (sitagliptin) and Bristol-Myers Squibb/AstraZeneca's Onglyza (saxagliptin).