European approval granted for Trajenta® (linagliptin) tablets as add-on therapy to insulin in adults with Type 2 Diabetes
BusinessWire · Oct. 26, 2012
Boehringer Ingelheim and Eli Lilly and Companytoday announced that the European Commission has approved an expanded therapeutic indication for the DPP-4 inhibitor Trajenta® (linagliptin) to include use in combination with insulin in adults with Type 2 Diabetes.
"We are delighted that approval has been granted for the use of linagliptin as an add-on to insulin in adults with Type 2 Diabetes," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, "This expanded indication shows that linagliptin is an effective treatment for patients at various stages of Type 2 Diabetes."
The approval means linagliptin is now indicated for use in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
The approval 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 profile 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.1
The US FDA approved linagliptin for use as add on to insulin in adults with Type 2 Diabetes in August 2012.
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