Single-Shot Xultophy Outperforms Basal-Bolus Insulin Regimen for Type 2 Diabetes

New clinical trial data presented at the American Diabetes Association’s 77th Scientific Sessions showed that a once-daily shot of Xultophy100/3.6 (insulin degludec and liraglutide injection; Novo Nordisk) was more effective and less costly compared with multiple daily insulin injections among patients with type 2 diabetes who are unable to control their blood glucose using basal insulin alone.

The research was part of the phase 3b DUAL VII clinical trials, which studied the efficacy of Xultophy compared with basal-bolus therapy in patients with type 2 diabetes. 

“The results of DUAL VII show that Xultophy 100/3.6 provided a similar reduction in A^1C compared to basal-bolus therapy while significantly reducing the number of hypoglycemic events along with a reduction in weight,” Todd Hobbs, MD, chief medical officer of Novo Nordisk in the United States, said in a press release. “These findings reinforce the importance of the ongoing development of new medicines to help adults better manage their type 2 diabetes.”

Liana K Billings, MD, of the department of medicine at the NorthShore University HealthSystem, presented the DUAL VII trial results. Dr Billings and colleagues conducted a 26-week, open-label trial, with 506 adult patients with type 2 diabetes. Study patients were unable to manage their type 2 Diabetes using metformin or insulin glargine. The researchers randomized the study participants to receive a once-daily shot of Xultophy or basal-bolus therapy injections 4 times a day. The basal-bolus group received a single shot of Lantus (insulin glargine injection; Sanofi) and three shots of NovoLog (insulin aspart [rDNA origin] injection; Novo Nordisk) daily.

Study results showed that at 26 weeks HbA^1C levels were comparable between both the Xultophy group and the basal-bolus group. However, the proportion of patients in the Xultophy group who achieved HbA^1C of less than 7% without hypoglycemia or weight gain was 10 times higher compared with the basal-bolus group.

Results also showed that patients in the Xultophy group experienced significantly lower rates of hypoglycemia. Furthermore, body weight increased among the patients in the basal-bolus group and decreased in the Xultophy group
(P < .0001).

Dr Billings and colleagues noted that patients required lower daily insulin dose in the Xultophy group (P < .0001), and the adverse events were similar across both study groups. 

Another analysis of the Dual VII trial data presented at American Diabetes Association’s 77th Scientific Sessions examined the cost-effectiveness of Xultophy compared with the basal-bolus regimen. The researchers found that the annual cost of Xultophy was lower, especially when costs associated with weight gain and hypoglycemia were included in the analysis. 

“These data suggest that [Xultophy] is a cost-effective treatment for patients failing to achieve glycemic control on basal insulin in the USA,” Dr Billings and colleagues concluded. 

This study was conducted with funding from Novo Nordisk. —David Costill