Insulin degludec/insulin aspart vs biphasic insulin aspart 30 twice daily in Japanese patients with type 2 diabetes: A randomized controlled trial

Yukiko Onishi, Kenichi Yamada, Jeppe Zacho, Jan Ekelund, Yasuhiko Iwamoto, Yukiko Onishi, Kenichi Yamada, Jeppe Zacho, Jan Ekelund, Yasuhiko Iwamoto

Abstract

Aims/introduction: Insulin degludec/insulin aspart (IDegAsp) is a soluble combination of insulin degludec (70%) and insulin aspart (30%). The present exploratory trial investigated the safety of switching unit-to-unit from twice-daily basal or pre-mix insulin to twice-daily IDegAsp in Japanese patients with type 2 diabetes.

Materials and methods: In this 6-week, open-label, parallel-group, controlled trial, 66 participants were randomized (1:1) to receive either IDegAsp or biphasic insulin aspart 30 (BIAsp 30) twice daily at the same total daily dose as pre-trial insulin. During the trial, insulin doses were adjusted according to a pre-specified algorithm to achieve pre-breakfast and pre-dinner plasma glucose of 4.4-7.2 mmol/L.

Results: No severe hypoglycemic episodes occurred. There were no statistically significant differences in rates of confirmed hypoglycemia (rate ratio IDegAsp/BIAsp 30: 0.63, 95% confidence interval: 0.31-1.30) and confirmed nocturnal hypoglycemia (rate ratio: 0.49, 95% confidence interval: 0.10-2.38) for IDegAsp vs BIAsp 30. The hypoglycemia rate for IDegAsp was constant over the 6 weeks of treatment. IDegAsp and BIAsp 30 were both safe and well tolerated. Reduction in fasting plasma glucose was statistically significantly greater for IDegAsp than for BIAsp 30 (estimated treatment difference, IDegAsp-BIAsp 30: -1.6 mmol/L, 95% confidence interval: -2.4 to -0.8). The apparent decrease in mean postprandial plasma glucose increment (IDegAsp: 4.2-3.8 mmol/L; BIAsp 30: 4.5-2.8 mmol/L) was not statistically significantly different between treatments (estimated treatment difference: 1.0 mmol/L, 95% confidence interval: -0.1 to 2.2).

Conclusions: Switching unit-to-unit from basal or pre-mix insulin to IDegAsp seems not to be associated with any concerns related to hypoglycemia or general safety in Japanese patients with type 2 diabetes.

Keywords: Insulin degludec/insulin aspart; Japanese; Type 2 diabetes.

© 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Figures

Figure 1
Figure 1
Trial flow diagram. The full analysis set included all randomized and exposed participants with at least one time‐point of fasting plasma glucose or nine‐point self‐measured plasma glucose profile after start of treatment. The safety analysis set included all randomized participants who received at least one dose of the trial product. BIAsp 30, biphasic insulin aspart 30; IDegAsp, insulin degludec/insulin aspart.
Figure 2
Figure 2
(a) Mean fasting plasma glucose over time, and (b) nine‐point self‐measured plasma glucose at 6 weeks for insulin degludec/insulin aspart (IDegAsp; circles) and biphasic insulin aspart 30 (BIAsp 30; squares). Data are mean ± standard error of the mean. FPG, fasting plasma glucose; SMPG, self‐measured plasma glucose.

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