Phase IIIb trial (DUAL VII) results with Xultophy (IDegLira) positive for treatment of type 2 diabetes.-Novo Nordisk.

Novo Nordisk announced new phase IIIb trial (DUAL VII) results with Xultophy (IDegLira). Xultophy is a once-daily, single injection fixed combination of a long-acting basal insulin (insulin degludec) and a glucagon-like peptide-1 (GLP-1) receptor agonist (liraglutide).

The open-label trial investigated the efficacy and safety of 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 Xultophy required 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. People treated with Xultophy showed a superior reduction of 89% in the rate of severe or blood glucose confirmed symptomatic hypoglycaemic episodes compared to insulin glargine U100 in combination with insulin aspart. Furthermore, from a mean baseline body weight of 87.7 kg, people treated with Xultophy experienced weight loss of 0.9 kg compared with weight gain of 2.6 kg for people treated with the basal-bolus regimen; a superior weight difference of -3.6 kg.

DUAL VII was a phase IIIb, 26-week, randomised, open-label, multicentre trial conducted in 12 countries with 506 patients.The trial was designed to investigate the safety and efficacy of Xultophy vs basal-bolus therapy in adults with type 2 diabetes previously treated with insulin glargine U100 and metformin.