The European Medicines Agency’s (EMA) medicinal committee has recommended the approval of Jentadueto, a type 2 diabetes drug, from Boehringer Ingelheim and Eli Lilly. Jentadueto (linagliptin/metformin hydrochloride) tablets are a medicine combining the DPP-4 inhibitor, linagliptin (the active ingredient in Tradjenta tablets, marketed under the trade name Trajenta inEurope) and metformin in a single tablet taken twice daily.The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of 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 or those already being treated with the combination of linagliptin and metformin. If approved by the European Commission, Jentadueto will provide a new, single-tablet treatment option, to be taken twice daily, for adults with type 2 diabetes who need to improve control of their blood glucose. It is not known if Jentadueto is safe and effective when used with insulin.
Jentadueto was approved by the U.S. FDA in January 2012 as a prescription medicine used along with diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate. In clinical studies, initial combination therapy with Jentadueto was superior to metformin monotherapy and to placebo in improving hemoglobin A1c (HbA1c or A1C) and fasting plasma glucose, with a similar safety and tolerability profile. No meaningful change in body weight was noted in any treatment group.
Jentadueto is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
