FDA approves Jentadueto™ (linagliptin/metformin hydrochloride) tablets for the treatment of adults with Type 2 Diabetes

New treatment combines DPP-4 inhibitor, linagliptin (the active ingredient in Trajenta™ [linagliptin] tablets), and metformin in a single tablet, taken twice-daily, to lower blood glucose in adults with Type 2 Diabetes - For Non-U.S. and Non-UK Media

Ingelheim, Germany and Indianapolis, USA, 31 January, 2012 – Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) have announced that the U.S. Food and Drug Administration (FDA) has approved Jentadueto™ (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. 1 Linagliptin/metformin hydrochloride (HCl) provides 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 Linagliptin (5 mg, once-daily) is marketed in the U.S. as Tradjenta™ (linagliptin) tablets, as Trajenta™ across Europe and Canada, and Trazenta™ in Japan, as well as in further markets. 2,3

Linagliptin/metformin HCl is a prescription medication used along with diet and exercise to improve glycaemic control in adults with Type 2 Diabetes when treatment with both linagliptin and metformin is appropriate. At the maximum dose, linagliptin/metformin HCl demonstrated placebo-corrected reductions in haemoglobin A 1c (HbA 1c or A1C) levels of up to 1.7 percent (+0.1 percent for placebo and -1.6 percent for linagliptin/metformin HCl). A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months. Linagliptin/metformin HCl did not cause any meaningful change in body weight. Linagliptin/metformin HCl can be used alone or in combination with a sulphonylurea, a commonly prescribed medication for Type 2 Diabetes. Linagliptin/metformin HCl are not for the treatment of Type 1 Diabetes or diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin. The linagliptin/metformin HCl label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with linagliptin/metformin HCl. 1