Jentadueto™ (linagliptin/metformin hydrochloride) tablets recommended for approval in the treatment of adults with Type 2 Diabetes in Europe
Ingelheim, Germany, 25 May, 2012 – Boehringer Ingelheim and Eli Lilly and Company today announced that they have received a positive opinion from the European Medicines Agency's (EMA) medicinal committee recommending approval of Jentadueto™, which combines the DPP-4 inhibitor, linagliptin (the active ingredient in Trajenta® tablets) and metformin in a single tablet. 1 If approved by the European Commission, linagliptin/metformin hydrochloride (HCl) will provide a new, single-tablet treatment option, taken twice-daily, for adults with Type 2 Diabetes who need to improve control of their blood glucose. 1 In clinical studies, linagliptin/metformin HCl demonstrated benefit to patients by offering another dosing option with effective glycaemic control and a favourable side effect profile.
The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of linagliptin/metformin hydrochloride (HCl) for use alongside diet and exercise to improve glycaemic control in adults with Type 2 Diabetes who are inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of linagliptin and metformin. In clinical trials, statistically significant, placebo-corrected mean reductions in haemoglobin A1c (HbA1c or A1C) levels of -1.7 percent were observed in patients with inadequate glycaemic control when the maximum dose of 2.5 mg linagliptin/1,000 mg metformin HCI was administered twice daily. 1 HbA1c is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months. In clinical studies, linagliptin/metformin HCl did not cause any significant change in body weight, and can be used alone or in combination with a sulphonylurea, a commonly prescribed medication for Type 2 Diabetes.