Insulin glargine in pediatric patients with type 1 diabetes in Japan

Abstract

BackgroundWe evaluated the safety and effectiveness of insulin glargine in Japanese pediatric patients with type 1 diabetes in clinical settings based on post-marketing surveillance data.MethodsClinical data were collected from Japanese pediatric patients with type 1 diabetes for 24 weeks after initiation of glargine treatment. Baseline characteristics, hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), previous/concomitant medication, height, bodyweight, and adverse events were analyzed.ResultsOne-hundred and thirteen patients were enrolled from 20 medical institutions in Japan in 2003 and 2004. Of these patients, 73 were included in the safety analysis, and 70 of these patients were also included in the efficacy analysis. The 73 patients included 28 boys and 45 girls, with a mean age of 11.8 years at entry. Hypoglycemia occurred in three patients (three events) and was severe in two patients (two events); all patients recovered. In the efficacy evaluation, HbA1c at baseline and final assessment was 9.10% and 8.09% (P < 0.001) in all patients; 8.96% and 7.85% (P < 0.001) in patients aged 7–12 years (Group 1); and 9.28% and 8.37% (P = 0.010) in patients aged 13–15 years (Group 2). FPG significantly decreased in all patients and in Group 1. No significant changes were observed in body mass index or degree of obesity during the study.ConclusionsGlargine therapy for Japanese pediatric patients with type 1 diabetes resulted in good glycemic control in terms of HbA1c and FPG as well as good safety in clinical settings. Glargine had little effect on the physical build of patients.

Efficacy and safety of switching from insulin glargine to insulin degludec in young people with type 1 diabetes

“…Insulin glargine (IGlar) has long been widely used as the main form of La, and reportedly lasts for up to 24 hours, though a waning effect can be seen at approximately 20 hours after the injection [9]. Approximately 70-80% of patients using IGlar give themselves a once-daily injection, whereas others require twice-daily injections to cover their 24-hour basal insulin supplementation [8][9][10][11]. Patients requiring twice-daily injections of basal insulin tend to need a higher dose of insulin to attain optimal glycemic targets, and experience more frequent episodes of hypoglycemia [8,10].…”

A randomized crossover study of the efficacy and safety of switching from insulin glargine to insulin degludec in children with type 1 diabetes

“…Several reports have indicated that most patients using insulin glargine (IGlar) must administer more than twice-daily injections to cover their 24-hour basal insulin supplementation [6][7][8]. Insulin degludec (IDeg) is an ultra-La recently developed by Nordisk (Bagsvaerd, Denmark) that constitutes soluble multihexamers after subcutaneous injection; these molecules slowly dissociate and allow a slow and stable release of monomers into the circulation, and thus extending the action of basal insulin formula to more than 40 hours.…”

Switching From Glargine to Degludec: The Effect on Metabolic Control and Safety During 1-Year of Real Clinical Practice in Children and Adolescents With Type 1 Diabetes

“…Approximately 70-80% of patients using IGlar need a once-daily injection, whereas others require twice-daily injections to cover their 24 h basal insulin supplementation. These latter patients were demonstrated to need a higher dose of insulin to attain optimal glycemic targets and to experience more frequent episodes of hypoglycemia ( 13 ).…”