Intensification of IDegAsp Twice Daily (Adding Insulin Aspart vs. Switching To Basal–Bolus): Exploratory Randomized Trial in Type 2 Diabetes

Introduction In a preceding trial comparing two different titration schemes, insulin degludec/insulin aspart (IDegAsp) showed good efficacy for achieving HbA1c Method A 26-week, randomized, open-label, phase 3b, treat-to-target trial in which 40 patients with T2D who had not reached target HbA1c ≤7.0% following previous 26-week treatment intensification with IDegAsp BID ±3 oral antidiabetic agents (OADs) were randomized (1:1) to receive IDegAsp BID + IAsp OD (n = 20) or IDeg OD + IAsp TID (n = 20). Results Mean baseline HbA1c was 7.9% in the IDegAsp BID + IAsp OD group and 7.7% in the IDeg OD + IAsp TID group. After 26 weeks, the estimated mean change in HbA1c from baseline was 0.05% points in the IDegAsp BID + IAsp OD group and −0.49% points for IDeg OD + IAsp TID: estimated treatment difference (ETD) [95% confidence interval] 0.54% [0.09; 0.99], p = 0.021. Few achieved HbA1c Conclusion When used as intensification regimens in patients who failed to achieve target HbA1c during 26-week IDegAsp BID treatment, HbA1c improvements were numerically greater with IDeg OD + IAsp TID compared with IDegAsp BID + IAsp OD. No new safety issues were identified. However, the small, selective sample means clinical generalizations should be made with caution. Funding Novo Nordisk. Clinicaltrials.gov identifier NCT01814137.