Safety and glycemic control with insulin degludec use in clinical practice: results from a 3-year Japanese post-marketing surveillance study

Takashi Murata; Lise Lotte N Husemoen; Satoko Nemoto; Munehide Matsuhisa

doi:10.1007/s13340-023-00657-7

Safety and glycemic control with insulin degludec use in clinical practice: results from a 3-year Japanese post-marketing surveillance study

Diabetol Int. 2023 Aug 18;15(1):76-85. doi: 10.1007/s13340-023-00657-7. eCollection 2024 Jan.

Authors

Takashi Murata^{1

2}, Lise Lotte N Husemoen³, Satoko Nemoto⁴, Munehide Matsuhisa⁵

Affiliations

¹ Department of Clinical Nutrition, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
² Diabetes Center, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
³ Novo Nordisk A/S, Søborg, Denmark.
⁴ Novo Nordisk Pharma Ltd, Tokyo, Japan.
⁵ Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University, 3-18-15 Kuramoto-cho, Tokushima, 770-8503 Japan.

PMID: 38264229
PMCID: PMC10800319 (available on 2024-08-18)
DOI: 10.1007/s13340-023-00657-7

Abstract

Introduction: Insulin degludec (degludec) is a basal insulin with a long duration of action. This post-marketing surveillance study monitored safety and glycemic control during use of degludec for 3 years in normal clinical practice in Japan.

Materials and methods: This multicenter, open-label, observational study included patients with diabetes receiving degludec in Japan between 2013 and 2019. The primary outcome was incidence of adverse events occurring over 3 years of treatment. The pre-specified, secondary outcomes were severe hypoglycemic episodes and changes in HbA1c and fasting plasma glucose levels.

Results: Of 4167 patients enrolled, 4022 were included in the safety assessments and 3918 in the assessments of glycemic control. Mean age was 58.9 years; 74.1% of patients had type 2 diabetes, and mean HbA1c at baseline was 8.7%. Adverse events and serious adverse events were observed in 19.1% and 8.9% of patients, respectively. Cardiac disorders and neoplasms were reported in 2.0% and 1.8% of patients, respectively, with the majority of these incidents reported as serious adverse events. Adverse drug reactions were seen in 8.0% of patients, mainly hypoglycemia. Hypoglycemic events were observed in 5.6% of patients, and severe hypoglycemic events in 1.7%. No serious allergic or injection-site reactions were seen. Respective changes (from baseline to 3 years' observation) in HbA1c and fasting plasma glucose levels were - 0.55% and - 36.3 mg/dL, and 19.6% of patients reached HbA1c < 7.0%.

Conclusions: Using degludec for 3 years in normal clinical practice had a good safety and tolerability profile. Improvements in glycemic control were also seen.

Supplementary information: The online version contains supplementary material available at 10.1007/s13340-023-00657-7.

Keywords: Basal insulin; Diabetes mellitus; Insulin; Observational study; Safety.

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