Insulin glargine in pediatric patients with type 1 diabetes in Japan.
BACKGROUND
We 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.


METHODS
Clinical 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.


RESULTS
One-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.


CONCLUSIONS
Glargine 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.
Department of Pediatrics, Nihon University School of Medicine, Tokyo, Japan.
Tatsuhiko
T
Urakami
Department of Medical Operations, Sanofi K.K., Tokyo, Japan.
Yusuke
Y
Naito
Division of Diabetes, Clinical Nutrition and Endocrinology, Kansai Electric Power Hospital, Osaka, Japan.
Yutaka
Y
Seino
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D000069036:Insulin Glargine / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies
D007004:Hypoglycemic Agents; D000069036:Insulin Glargine
degree of obesity; glycemic control; hypoglycemia; insulin glargine; pediatric patients with type 1 diabetes