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.

Autor: Kadowaki T; Department of Metabolic Diseases, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Japan., Jinnouchi H; Iryo Houjin Shadan Jinnouchikai, Jinnouchi Hospital, Kumamoto, Japan., Kaku K; Department of Internal Medicine, Kawasaki Medical School, Okayama, Japan., Hersløv ML; Medical & Science, Novo Nordisk A/S, Søborg, Denmark., Hyllested-Winge J; Medical & Scientific Affairs, Novo Nordisk Pharma Ltd, Tokyo, Japan., Nakamura S; Iryo Houjin Shadan Kowakai Heiwadai Hospital, Miyazaki, Japan.
Jazyk: angličtina
Zdroj: Journal of diabetes investigation [J Diabetes Investig] 2016 Sep; Vol. 7 (5), pp. 711-7. Date of Electronic Publication: 2016 Apr 01.
DOI: 10.1111/jdi.12502
Abstrakt: 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.
(© 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.)
Databáze: MEDLINE
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