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Clinical Trial
. 2019 Jul;21(7):1652-1660.
doi: 10.1111/dom.13703. Epub 2019 Apr 4.

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

Wenying Yang  1 , Jianhua Ma  2 , Tianpei Hong  3 , Ming Liu  4 , Heng Miao  5 , Yongde Peng  6 , Changjiang Wang  7 , Xiangjin Xu  8 , Tao Yang  9 , Anne M Nielsen  10 , Lili Pan  11 , Weihong Liu  11 , Weigang Zhao  12
Affiliations
Clinical Trial

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

Wenying Yang et al. Diabetes Obes Metab. 2019 Jul.

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.

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Conflict of interest statement

A.M.N. is an employee and a stock/shareholder of Novo Nordisk A/S. W.L. and L.P. are employees of Novo Nordisk (China) Pharmaceuticals Co. Ltd. T.H. is on an advisory panel and is a speakers' bureau member for Novo Nordisk, Sanofi, AstraZeneca and Merck Serono, is on an advisory panel for Merck Sharp & Dohme, and is a speakers' bureau member for Eli Lilly and Bayer. W.Y., J.M., M.L., H.M., Y.P., C.W., X.X., T.Y. and Z.W. have no conflicts of interest to declare. No other potential conflicts of interest relevant to this article are reported.

Figures

Figure 1
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
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
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References

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