Novo Nordisk today announced new phase 3b 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). 1 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 (estimated treatment difference (ETD): -0.02, 95% confidence interval (CI): -0.16; 0.12; p<0.0001).
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 (estimated rate ratio: [episodes per 100 patient year exposure] 0.11, 95% CI: 0.08; 0.17; p<0.0001).
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 (p<0.0001).
“We are excited about the results of DUAL VII, showing the important benefits Xultophy® offers for people inadequately controlled on insulin glargine U100 as an alternative to intensification with basal-bolus therapy” said Mads Krogsgaard Thomsen, executive vice president and chief science officer, Novo Nordisk A/S. “Xultophy® shows these impressive results, including reduction in hypoglycaemia and body weight, with a much lower dose compared to insulin glargine U100 in combination with insulin aspart at the end of the study.”
The safety profile of Xultophy® in DUAL VII was generally consistent with previous Xultophy® clinical trials.
The complete trial results will be presented in the first half of 2017.