Xultophy (IDegLira) + metformin superior to insulin glargine + metformin in reduction of HbA1c in type 2 diabetes- Novo Nordisk

New phase IIIb findings showed adults with type 2 diabetes treated with Xultophy (IDegLira- insulin degludec + liraglutide), a once-daily, single-injection combination of insulin degludec and liraglutide from Novo Nordisk,demonstrated statistically significant reduction in HbA1c (average blood glucose over the previous three months), change in body weight and a lower rate of hypoglycaemia compared with patients treated with insulin glargine. Findings from the phase IIIb DUAL V 26-week trial that compared the efficacy and safety of Xultophy versus insulin glargine, both added on to metformin, in patients with type 2 diabetes uncontrolled on insulin glargine (20–50 units/day), were presented today at the 75th Annual Scientific Sessions of the American Diabetes Association (ADA) in Boston, Massachusetts, United States. At 26 weeks, patients randomised to Xultophy treatment achieved a statistically significant mean reduction in HbA1c of 1.8% from baseline (8.4% to 6.6%) compared with a 1.1% reduction (8.2% to 7.1%) achieved by patients who further increased their dose of insulin glargine (p<0.001). In the Xultophy group, 72% of patients achieved an HbA1c of <7% at the end of the trial, compared with 47% of patients in the insulin glargine group (p?0.001). Furthermore, 39% of patients treated with Xultophy achieved an HbA1c <7% without hypoglycaemia and weight gain versus 12% treated with insulin glargine (p<0.001).

There was a 57% lower rate of confirmed hypoglycaemia with Xultophy compared with insulin glargine (2.23 episodes/patient-year vs 5.05 episodes/patient-year; p<0.001). Additionally, there was a significant difference of 3.2 kg (7.1 lb) in change in body weight between treatment groups (p<0.001); body weight decreased by 1.4 kg (3.0 lb) from baseline for patients treated with Xultophy and increased by 1.8 kg (4.0 lb) for patients treated with insulin glargine. Patients treated with Xultophy required significantly less insulin than patients treated with insulin glargine, demonstrated by the end-of- trial dose of 41 units of the insulin degludec component in Xultophy versus 66 units respectively (p<0.001). In the DUAL V trial, there were similar rates of overall and serious adverse events in the two treatment groups.

Comment: Xultophy is approved in Europe, but the combination treatment's U.S. 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.