The European Commission has approved an extension of the indications of the DPP-4 Linagliptin inhibitor, marketed by Boehringer and Lilly with the name of 'Suitanta', to allow its use combined with insulin in adult patients with type 2 diabetes.
According to this approval, the drug may be used in combination with insulin with or without metformin, when treatment only with diet and exercise does not provide adequate glycemic control.
The approval is based on the data of several clinical studies, including efficacy data of a phase III trial of 52 weeks, which demonstrates the efficacy and safety profile of linagliptin in combination with basal insulin (main valuation criteria: Effectiveness later24 weeks of treatment).
Specifically, this trial has shown that, after 24 weeks, the combination of linagliptin with insulin produces better glucose control than insulin alone, without an additional risk of hypoglycemia.
"We are delighted with the approval of linagliptin for use as a complement to insulin in adults with type 2 diabetes," says Professor Klaus Dugi, a senior corporate vice president of Medicine of Boehringer Ingelheim, who adds that "this extension shows that linagliptin is aEffective treatment for patients in various phases of type 2 diabetes ".
This decision adds to the adopted last August by the American Drug Agency (FDA), which already giving green light to the use of linagliptin in combination with insulin.
