New Phase IIIb trial (DUAL VII) results with Xultophy (IDegLira), which was approved by the US Food and Drug Administration last month, were presented today.
The open-label trial investigated the efficacy and safety of Danish diabetes giant Novo Nordisk’s (NOV: N) Xultophy compared with insulin glargine U100 in combination with insulin aspart at all main meals, after 26 weeks of treatment in 506 adults with type 2 diabetes.
The trial successfully achieved its objective by demonstrating that treatment with Xultophy is non-inferior to insulin glargine U100 in combination with insulin aspart with regards to lowering of HbA1c. From a mean baseline HbA1c of 8.2%, both patient groups reached a similar HbA1c level of 6.7% after 26 weeks of treatment. At the end of the trial, people treated with Xultophyrequired 40.1 units compared to a total of 84.6 units of insulin for people treated with insulin glargine U100 in combination with insulin aspart. 3
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