Open AccessEfficacy 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
Author(s) -
Kadowaki Takashi,
Jinnouchi Hideaki,
Kaku Kohei,
Hersløv Malene L,
HyllestedWinge Jacob,
Nakamura Shuji
Publication year - 2016
Publication title -
journal of diabetes investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.089
H-Index - 50
eISSN - 2040-1124
pISSN - 2040-1116
DOI - 10.1111/jdi.12502
Subject(s) - medicine , dosing , insulin glargine , glycated hemoglobin , hypoglycemia , insulin degludec , confidence interval , type 2 diabetes , diabetes mellitus , adverse effect , insulin , endocrinology
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 ( ID eg) 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 ID eg flexible (allowing dosing ±8 h from an agreed dosing time) with ID eg 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, ID eg flexible was non‐inferior to ID eg 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 ID eg flexible and ID eg 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 ID eg flexible vs ID eg fixed dosing. The rates of adverse events with ID eg flexible and ID eg fixed dosing were similar. Conclusions These results showed the efficacy and safety of allowing patients to vary the time they dosed ID eg, when necessary, in Japanese patients with type 2 diabetes. Dosing of ID eg at a time convenient to the patient was non‐inferior, with respect to glycated hemoglobin, to dosing at the same time each day.