Novo Nordisk have announced the UK launch of Xultophy®, the first ever single-device combination of insulin degludec, a long-acting basal insulin analogue, and liraglutide, a glucagon-like peptide-1 receptor agonist.
Xultophy, which is known generically as IDegLira, is approved by the European Medicines Agency to improve glycaemic control in adults with type 2 diabetes, in combination with oral glucose-lowering drugs when these alone or combined with basal insulin do not provide adequate glycaemic control. It is administered in “dose steps”, whereby each dose step contains 1 unit of insulin and 0.036 mg of liraglutide.
The manufacturers have priced Xultophy lower than the sum of its two constituents, with a set of five 3-mL prefilled pens (each with 300 dose steps) costing £159.22. A typical user who switches from basal insulin will begin treatment on 16 dose steps per day, costing approximately £1.70 per day.
The agent has been launched following results of the phase IIIb DUAL V study, presented at the 75th Annual Scientific Sessions of the American Diabetes Association (Boston, MA, USA). In this 26-week study conducted in 557 people with type 2 diabetes who had failed to achieve glycaemic control whist receiving insulin glargine (mean, 32 units), Xultophy recipients had significantly greater reductions in HbA1c compared with participants who continued with dose escalation of glargine (mean reduction, 14.7 mmol/mol [1.8%] vs 12.0 mmol/mol [1.1%]; P<0.001). They also had a 57% lower rate of confirmed hypoglycaemia, a decrease in body weight of 1.4 kg, compared with an increase of 1.8 kg, and a significantly lower insulin requirement (final dose, 41 units of the insulin degludec component of Xultophy vs 66 units of insulin glargine).
Commenting on the launch, Gwen Hall (Independent Diabetes Specialist Nurse and Associate Clinical Teacher, Surrey) said: “Many people with type 2 diabetes would benefit from intensifying their basal insulin treatment but face additional barriers in terms of hypoglycaemia, weight gain and a potential increase in the number of daily injections they have to take, meaning their diabetes is not optimally controlled. The data from the clinical trials suggest that once-daily Xultophy could help to reduce some of the obstacles people face and it is very welcome news that it is available for patients.”
The Summary of Product Characteristics of Xultophy can be found here.
