Twice-daily type 2 diabetes drug gets EU thumbs up

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The marketing authorization from the European Commission has granted Boehringer Ingelheim and Eli Lilly regulatory approval of Jentadueto (linagliptin/metformin hydrochloride) tablets, a medicine combining the DPP-4 inhibitor, linagliptin (the active ingredient in Tradjenta tablets, marketed under the trade name Trajenta in Europe) and metformin in a single tablet taken twice daily.

The European Commission has approved Jentadueto for use alongside diet and exercise to improve glycemic control in adults with type 2 diabetes who are inadequately controlled on their maximally tolerated dose of metformin alone, metformin and a sulfonylurea, or those already being treated with the combination of linagliptin and metformin. It may be used with a sulfonylurea, as well.

Jentadueto provides a single-tablet treatment option, taken twice daily, for adults with type 2 diabetes who need to improve control of their blood glucose. Jentadueto was approved by the FDA in January as a prescription medicine used along with diet and exercise that seeks to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate. The Jentadueto U.S. label contains a boxed warning for the risk of lactic acidosis, a metabolic complication that can occur due to metformin accumulation during treatment with Jentadueto.

Adverse reactions reported in greater than or equal to 5 percent of patients treated with Jentadueto and more commonly than in patients treated with placebo included nasopharyngitis (common cold) and diarrhea. Hypoglycemia was more commonly reported in patients treated with the combination of Jentadueto and sulfonylurea compared with those treated with the combination of placebo, sulfonylurea and metformin. Pancreatitis was reported more often in patients randomized to linagliptin (one per 538 person-years versus zero in 433 person-years for comparator), according to the company's reporting.

Linagliptin (5 mg, once daily) is marketed as Trajenta across Europe and Canada, as Tradjenta in the U.S., and Trazenta in Japan, as well as in additional markets.