Patient-reported outcomes with IDegLira versus BB therapy in patients with T2D: DUAL VII trial

Background and aims: Basal-bolus (BB) insulin therapy is considered the gold standard regimen for treating patients with T2D who do not achieve glycaemic control with basal insulin, but fear of hypoglycaemia and weight gain are barriers to therapy intensification. The aim of this analysis was to see whether IDegLira could provide an alternative intensification option that was more acceptable to patients. Materials and Methods: 26-week open-label trial, 506 adult patients with T2D, HbA1c 7-10% on metformin (Met) and 20-50 units insulin glargine 100 units/mL (IGlar U100) were randomised 1:1 to receive once-daily (OD) IDegLira or BB (OD IGlar U100 + insulin aspart <4 times a day). Patients’ perceived health status and treatment experiences were quantified using PROs questionnaires. Results: Patients on IDegLira had an equal reduction in HbA1c, lower burden of hypoglycaemia, fewer injections/day, and weight loss vs. BB. Treatment-Related Impact Measure-Diabetes (TRIM-D) showed greater improvements in favour of IDegLira vs. BB in all domains and Total Score (estimated treatment difference [ETD] 6.50 [95% CI 4.44; 8.57] p<0.0001). The greatest improvements were in diabetes management (likely driven by items on avoiding hypoglycaemia/ weight gain), treatment burden and compliance. SF-36 ETD was in favour of IDegLira vs. BB for the mental component summary (1.83 [95% CI 0.26; 3.40] p=0.023), driven by an improvement in mental health (ETD 2.29 [95% CI 0.62; 3.96] p=0.0074). In a motivation survey 26 weeks after randomisation, 84.5% of IDegLira patients were willing to stay on study therapy vs. 68.1% of BB patients (OR 2.54 [95% CI 1.63; 3.98] p<0.0001) 16.8% of IDegLira patients preferred pre-trial therapy vs. 28.0% BB (OR 0.52 [95% CI 0.33; 0.81] p=0.004). Conclusion: IDegLira induced greater improvements in PROs, mainly in diabetes management and treatment burden, whilst achieving similar glycaemic control versus BB in patients with HbA1c 7-10% switched from Met and IGlar U100.