IDegAsp is the first coformulation of long-acting basal (degludec) and bolus (IAsp) insulin with no need for re-suspension. This 26-week, phase 3, open-label, treat-to-target, 2:1, randomized trial assessed the efficacy and safety of IDegAsp BID vs. BIAsp 30 BID ±metformin in Chinese adults (N=541) with T2D inadequately controlled on pre-/self-mix or basal insulin ±metformin (NCT02762578). Hierarchical testing was used with non-inferiority of A1C change from baseline to week 26 as the primary endpoint and superiority for secondary endpoints. Non-inferiority of A1C change from baseline to week 26 and statistical superiority of IDegAsp BID vs. BIAsp 30 BID for change in fasting plasma glucose, nocturnal (00:01-05:59 hours inclusive) confirmed hypoglycemic and confirmed hypoglycemic episodes (severe or plasma glucose <56mg/dL with or without symptoms) was confirmed (Table). Significantly more patients reached A1C <7% without confirmed hypoglycemia with IDegAsp BID vs. BIAsp 30 BID by week 26. Daily insulin dose (U/kg [SD]) was lower in patients receiving IDegAsp BID vs. BIAsp 30 BID at week 26 (0.78 [0.35] vs. 0.95 [0.35]). No new safety signals were identified. These results demonstrate the efficacy and safety of IDegAsp in Chinese patients with T2D, confirming results from other international trials comparing the two treatment modalities (NCT02762578).
W. Yang: None. J. Ma: None. T. Hong: Advisory Panel; Self; Novo Nordisk A/S, AstraZeneca. M. Liu: None. H. Miao: None. Y. Peng: None. C. Wang: None. X. Xu: None. T. Yang: None. A. Moeller Nielsen: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. L. Pan: Employee; Self; Novo Nordisk (China). W. Liu: Employee; Self; Novo Nordisk (China). Z. Weigang: None.