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New phase 3b results from Novo Nordisk

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Novo Nordisk has 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 HbA1cof 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.

“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.