A combined tablet formulation of empagliflozin and linagliptin has been approved for adults with type 2 diabetes by the Food and Drug Administration, according to Boehringer Ingelheim Pharmaceuticals.

The approved indication is to improve glycemic control, as an adjunct to diet and exercise, in adults with type 2 diabetes, when both agents are appropriate treatments, the company said in a statement issued Feb 2.

Empagliflozin (marketed as Jardiance) is a sodium glucose cotransporter–2 (SGLT2) inhibitor, which reduces renal absorption of glucose and increases the excretion of urinary glucose. It was approved in August 2014. Linagliptin (marketed as Tradjenta) is a dipeptidyl peptidase–4 (DPP-4) inhibitor, which increases the concentrations of incretin hormones, “stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation,” according to the prescribing information . It was approved in 2011. In 2012, linagliptin was approved in a combination tablet with metformin (Jentadueto).

Approval was based on a phase III study of 677 patients with type 2 diabetes not adequately controlled on at least 1,500 mg of metformin a day. At 24 weeks, those randomized to treatment with empagliflozin 10 mg or 25 mg in combination with 5 mg of linagliptin, as the fixed-dose combination tablet, had statistically significant improvements in hemoglobin A1c and fasting blood glucose levels at 24 weeks, compared with those on the individual components. Reductions with empagliflozin 10 mg/linagliptin 5 mg were significantly greater than with the individual components, and reductions with empagliflozin 25 mg/linagliptin 5 mg were significantly greater, compared with linagliptin 5 mg but not compared with empagliflozin 25 mg, according to the trial results, published online Jan. 29 (Diabetes Care 2015 [ doi:10.2337/dc14-2365 ]) . The approved product contains 10 mg empagliflozin/5 mg linagliptin, to be taken once daily in the morning.

The most common adverse reactions associated with the combination were urinary tract infections (in 11.4%-12.5% of treated patients), as well as nasopharyngitis and upper respiratory tract infections, according to the prescribing information .

The combination tablets will be marketed as Glyxambi by Boehringer Ingelheim and Eli Lilly. This is the first product that combines these two drug classes into one tablet, according to the release.

Serious adverse events associated with this product and other drugs should be reported to the FDA at 800-332-1088 or www.fda.gov/Safety/MedWatch.



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