CHMP recommends use of Tradjenta (Boehringer/Eli Lilly) with Insulin in Type 2 Diabetes patients - 25-Sep-2012

Boehringer Ingelheim and Eli Lilly and Company have announced that they have received a Positive Opinion from the European Medicines Agency’s (EMA) medicinal committee recommending expanding the therapeutic indication for the DPP-4 inhibitor Trajenta (linagliptin). If approved by the European Commission, this will expand the indicated use of Trajenta by the combination with insulin in adults with Type 2 Diabetes. The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of linagliptin in combination with insulin with or without metformin, when this regimen alone, with diet and exercise does not provide adequate glycaemic control. The CHMP’s Positive Opinion is based on data from a number of clinical studies, including efficacy data from a phase III trial of at least 52 weeks duration demonstrating the efficacy and safety of linagliptin in combination with basal insulin (primary endpoint: efficacy after 24 weeks). The trial results showed that after 24 weeks, adding linagliptin to insulin produced better glucose control than insulin alone, without an additional risk of hypoglycaemia.