Positive results in DUAL V phase III trial of Xultophy (insulin degludec plus liraglutide) in type 2 diabetes- Novo Nordisk

New findings from the DUAL V phase IIIb clinical trial showed greater improvements in treatment-related satisfaction and patient-reported physical health in people treated with Xultophy (insulin degludec plus liraglutide), from Novo Nordisk, versus insulin glargine U100. The DUAL V trial evaluated the efficacy and safety of Xultophy, also known as IDegLira, a once-daily single-injection combination of Tresiba (insulin degludec) and Victoza (liraglutide) compared to further intensification with insulin glargine U100 in adults with type 2 diabetes uncontrolled on insulin glargine U100. In addition, findings from the DUAL V clinical trial demonstrated that people with type 2 diabetes treated with Xultophy versus insulin glargine U100 achieved superior HbA1c reductions (1.8% vs 1.1%), body weight change (1.4 kg decrease vs 1.8 kg increase, a 3.2 kg difference) and a 57% lower rate of confirmed hypoglycaemia (2.2 vs 5.1 events per patient year exposure). The findings based on validated patient-reported outcomes (PRO) questionnaires completed by participants in the DUAL V trial were announced at the 51st European Association for the Study of Diabetes.

Comment: Xultophy is approved in Europe, but the combination treatment's US potential is undecided after the FDA rejected Tresiba (insulin degludec) last year over cardiovascular risks. The FDA required Novo to provide long-term CV outcomes data. Novo resubmitted its application in the US in April 2015 together with an interim analysis from the ongoing DEVOTE study.