Efficacy and safety of once-daily insulin degludec dosed flexibly at convenient times vs fixed dosing at the same time each day in a Japanese cohort with type 2 diabetes: A randomized, 26-week, treat-to-target trial

Takashi Kadowaki, Hideaki Jinnouchi, Kohei Kaku, Malene L Hersløv, Jacob Hyllested-Winge, Shuji Nakamura, Takashi Kadowaki, Hideaki Jinnouchi, Kohei Kaku, Malene L Hersløv, Jacob Hyllested-Winge, Shuji Nakamura

Abstract

Aims/introduction: This trial assessed the efficacy and safety of the possibility of varying the daily injection time of once-daily, long-acting basal insulin degludec (IDeg) in Japanese patients with type 2 diabetes inadequately controlled with insulin glargine.

Materials and methods: This was a 26-week, multicenter, open-label, randomized, treat-to-target trial, with a 2 × 2 factorial design comparing IDeg flexible (allowing dosing ±8 h from an agreed dosing time) with IDeg fixed dosing (at the same time each day). It was carried out in 458 adult patients who were inadequately controlled on insulin glargine with or without oral antidiabetic drugs.

Results: The majority of doses were taken within 2 h of the agreed dosing time, showing a high level of adherence among Japanese patients. After 26 weeks, IDeg flexible was non-inferior to IDeg fixed with respect to change in glycated hemoglobin from baseline, estimated treatment difference 0.08% points (95% confidence interval -0.05; 0.22). Fasting plasma glucose decreased to a similar level with IDeg flexible and IDeg fixed, estimated treatment difference -0.18 mmol/L (95% confidence interval -0.48; 0.12). The rates of confirmed and nocturnal confirmed hypoglycemia were numerically, but not significantly, higher with IDeg flexible vs IDeg fixed dosing. The rates of adverse events with IDeg flexible and IDeg fixed dosing were similar.

Conclusions: These results showed the efficacy and safety of allowing patients to vary the time they dosed IDeg, when necessary, in Japanese patients with type 2 diabetes. Dosing of IDeg at a time convenient to the patient was non-inferior, with respect to glycated hemoglobin, to dosing at the same time each day.

Keywords: Basal insulin; Clinical trial; Type 2 diabetes mellitus.

© 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
Study design. HbA1c, glycated hemoglobin; IDeg, insulin degludec; IGlar, insulin glargine; OADs, oral antidiabetic drugs; T2D, type 2 diabetes; V, visit.
Figure 2
Figure 2
Patient disposition. FAS, full analysis set; IDeg, insulin degludec; SAS, safety analysis set.
Figure 3
Figure 3
Glycated hemoglobin (HbA1c) over time. Data are full analysis set; last observation carried forward. CI, confidence interval; IDeg, insulin degludec.

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