Efficacy and safety of insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Chinese adults with type 2 diabetes: A phase III, open-label, 2:1 randomized, treat-to-target trial

Abstract

Aims: To assess the efficacy and safety of twice-daily insulin degludec/insulin aspart (IDegAsp) versus biphasic insulin aspart 30 (BIAsp 30) twice daily, both ± metformin, in Chinese adults (N = 543) with type 2 diabetes (T2D) inadequately controlled on premixed/self-mixed or basal insulin ± metformin.

Materials and methods: We conducted a 26-week, phase III, open-label, treat-to-target, 2:1 randomized trial. Hierarchical testing was used with non-inferiority of glycated haemoglobin (HbA1c) change from baseline to week 26 as the primary endpoint and superiority for the confirmatory secondary endpoints which were as follows: change from baseline in fasting plasma glucose (FPG); nocturnal confirmed hypoglycaemic episodes (12:01-5:59 am, inclusive); total confirmed hypoglycaemic episodes (severe or plasma glucose <3.1 mmol/L with/without symptoms); body weight; and percentage of responders (HbA1c <53 mmol/mol [<7.0%]) without confirmed hypoglycaemic episodes.

Results: Non-inferiority for change from baseline to week 26 in HbA1c and superiority of IDegAsp twice daily versus BIAsp 30 twice daily for change in FPG, nocturnal confirmed and total confirmed hypoglycaemic episodes, was demonstrated. Estimated rates of nocturnal confirmed and total confirmed hypoglycaemic episodes were 47% and 43% lower, respectively, with IDegAsp twice daily versus BIAsp 30 twice daily. Superiority for change in body weight was not confirmed. Participants were more likely to reach the HbA1c goal of <53 mmol/mol (<7.0%) without confirmed hypoglycaemia with IDegAsp twice daily versus BIAsp 30 twice daily by trial end. No new safety signals were identified.

Conclusions: The efficacy and safety of IDegAsp in Chinese patients with T2D was demonstrated, confirming results from international trials.

Keywords: biphasic insulin aspart; insulin aspart; insulin degludec; insulin treatment; intensive insulin therapy; type 2 diabetes.

Figure 1

Participant disposition. Three participants who were previously treated with bolus insulin were randomized in error: two participants in the IDegAsp group who had been treated with bolus insulin with metformin and one participant in the BIAsp 30 group who was categorized as receiving “premixed/self‐mixed insulin” but had previously received basal plus bolus medication. BIAsp 30, biphasic insulin aspart 30; IDegAsp, insulin degludec/insulin aspart; n, number of participants; N, total number of participants

Figure 2

Confirmed endpoints between baseline and week 26: A, glycated haemoglobin (HbA1c); B, fasting plasma glucose (FPG) levels; C, nocturnal confirmed hypoglycaemic episodes; and D, confirmed hypoglycaemic episodes. HbA1c (A) and FPG (B) data are shown for all randomized participants; hypoglycaemia data (C and D) are shown for participants who were exposed to treatment. Data at week 26 are last observed values. BIAsp 30, biphasic insulin aspart 30; IDegAsp, insulin degludec/insulin aspart; n, number of patients