It was found that once-daily Xultophy was more effective at managing diabetes than a basal-bolus insulin regimen requiring multiple daily injections for Type 2 patients whose blood sugar was not controlled on insulin glargine U100 with metformin.
The trial employed a patient-reported outcomes analysis to quantify benefits presented by Xultophy in diabetes management. As part of the trial, the 506 participants assessed their mental and physical health, as well as factors specific to their condition via the validated Treatment-Related Impact Measure-Diabetes (TRIM-D) questionnaire and Short Form Health Survey 36 v2 (SF-36). It was found that the patients treated with Xultophy reported better experiences in outcome measures related to diabetes management, treatment burden and compliance.
“Adding insulin injections at mealtime is an effective option to achieve desired blood glucose levels when basal insulin is not enough, but this raises the level of complexity in the patients' daily management of their diabetes,” explained Professor Esteban Jódar, University Hospital Quirón Salud in Madrid. “It can also lead to an increased risk of hypoglycaemia (low blood sugar) or weight gain. In the main analysis of the DUAL VII trial, Xultophy delivered similar glucose reductions to a basal-bolus regimen alongside weight loss, as opposed to weight gain, and fewer episodes of hypoglycaemia. We now see that it also reduces treatment burden.”
From the analysis of a separate real-world evidence trial, it was also found that the company’s Tresiba demonstrated the ability to regulate blood sugar levels when patients switched to it from another basal insulin therapy.
In those with Type 2 diabetes whose blood sugar levels are controlled with basal insulin prior to switching, Tresiba reduced hypoglycaemia rates by 67% over six months, with an 11% lower dose of insulin. In those with uncontrolled type 1 or 2 forms of the condition, switching to Tresiba produced “significantly improved glycaemic control” without a higher hypoglycaemia risk or insulin dose, with results sustained for up to 12 months after making the switch.
In controlled forms of type 1 diabetes, switching to Novo’s drug showed a 16% reduction in hypoglycaemia rates over six months, maintaining blood sugar control with a 13% reduction in insulin dose.
“This new analysis shows that people with diabetes who have switched to Tresiba in the real world benefit from this change, regardless of whether they did so to improve blood glucose control or reduce the risk of hypoglycaemia,” commented Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer at Novo Nordisk. “This confirms that the benefits of Tresiba seen in clinical trials are being reproduced in clinical practice.”