Improved treatment satisfaction with once-weekly IcoSema vs daily basal-bolus therapy in adults with type 2 diabetes inadequately controlled on daily basal insulin: COMBINE 3

초록

Background and aims: COMBINE 3 evaluated the efficacy and safety of IcoSema, a once-weekly combination of basal insulin icodec and the glucagon-like peptide-1 analogue semaglutide, vs daily basal-bolus therapy (BBT) in adults with type 2 diabetes (T2D). At week 52, the increase from baseline in the Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) total treatment satisfaction score was statistically significantly greater with IcoSema vs daily BBT (estimated change from baseline: +4.47 vs +1.40; estimated treatment difference [95% CI]: 3.06 [2.04; 4.09], p<0.0001). Here, we report changes in the individual DTSQs item scores. Materials and methods: In COMBINE 3, a 52-week, open-label, treat-to-target, phase 3a trial, adults (aged ≥ 18 years) with T2D (HbA1c: 7.0-10.0%) receiving daily basal insulin (20-80 U/day) were randomised 1:1 to once-weekly IcoSema (n=340) or daily BBT (glargine U100 + aspart; n=339). Participants completed the DTSQs at baseline and week 52. Results: At week 52, statistically significantly greater increases from baseline were reported with IcoSema vs daily BBT on the following DTSQs items: participants’ satisfaction with current treatment, convenience, flexibility, participants’ willingness to recommend treatment to others and satisfaction to continue trial treatment (p<0.0001 for all; Figure A). There were statistically significant reductions with IcoSema vs daily BBT in the perception of having unacceptable hyperglycaemia (p=0.0001) and hypoglycaemia (p<0.0001). The estimated odds of achieving a clinical meaningful improvement (>0.5 SD increase from baseline) in the DTSQs total treatment satisfaction score as well as the following DTSQs items - treatment convenience, flexibility, willingness to recommend treatment to others and satisfaction to continue trial treatment - were all statistically significantly greater with IcoSema vs daily BBT (p<0.05 for all; Figure B). For IcoSema vs daily BBT, there were statistically significantly higher estimated odds of achieving a clinically meaningful reduction (>0.5 SD decrease from baseline) in the perception of having unacceptable hyperglycaemia (p<0.0001) and hypoglycaemia (p<0.0001). Conclusion: The statistically significant estimated improvement in the total treatment satisfaction score with once-weekly IcoSema vs daily BBT appeared to be driven by satisfaction with current treatment, convenience, flexibility, willingness to recommend treatment to others and satisfaction to continue trial treatment.