title: A 1-year, prospective, observational study of Japanese outpatients with type 1 and type 2 diabetes switching from insulin glargine or detemir to insulin degludec in basal-bolus insulin therapy (Kumamoto Insulin Degludec Observational study).
abstract: OBJECTIVE
  The aim of the present prospective observational study was to assess long-term efficacy and safety of insulin degludec as a part of a basal-bolus therapy for Japanese patients with type 1 or type 2 diabetes in routine clinical practice.
  
  
  METHODS
  In the present study, 93 type 1 diabetes patients and 135 type 2 diabetes patients treated with insulin glargine or detemir were switched from their basal insulin to insulin degludec. The primary end-points were the changes in glycated hemoglobin (HbA1c) from baseline at 3, 6 and 12 months. The secondary end-points were changes in body mass index, insulin dose, frequency of hypoglycemia and adverse events.
  
  
  RESULTS
  HbA1c levels from baseline were significantly reduced at 3, 6, and 12 months by 0.4, 0.4 and 0.3% in type 1 diabetes patients, respectively, and by 0.5, 0.5 and 0.3% in type 2 diabetes patients, respectively. Body mass index in type 1 diabetes patients increased significantly (P < 0.05), whereas that in type 2 diabetes patients did not change. Basal insulin dose decreased significantly at 3 months after switching (P < 0.05), and returned baseline dose at 12 months in type 1 diabetes and type 2 diabetes patients. The frequency of both total and nocturnal hypoglycemia decreased significantly in type 1 diabetes and type 2 diabetes patients (P < 0.05). The result of multiple regression analysis showed that baseline HbA1c was a significant independent variable of the percentage change in HbA1c with switching.
  
  
  CONCLUSIONS
  In both type 1 diabetes and type 2 diabetes patients, switching from insulin glargine or insulin detemir to insulin degludec led to improvement of glycemic control with a significant reduction of hypoglycemia.
authors.affiliation: Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Seiya
authors.initials: S
authors.lastname: Shimoda
authors.affiliation: Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Miki
authors.initials: M
authors.lastname: Sato
authors.affiliation: Kumamoto General Hospital, Japan Community Healthcare Organization, Kumamoto, Japan.|Sekigami Clinic, Kumamoto, Japan.
authors.forename: Taiji
authors.initials: T
authors.lastname: Sekigami
authors.affiliation: Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Motoshima
authors.affiliation: Yoshimura Clinic, Kumamoto, Japan.
authors.forename: Ryohei
authors.initials: R
authors.lastname: Yoshimura
authors.affiliation: Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.|Amakusa Central General Hospital, Japan Community Healthcare Organization, Kumamoto, Japan.
authors.forename: Kazuki
authors.initials: K
authors.lastname: Fukuda
authors.affiliation: Saiseikai Kumamoto Hospital, Kumamoto, Japan.
authors.forename: Yasuto
authors.initials: Y
authors.lastname: Matsuo
authors.affiliation: Hitoyoshi General Hospital, Kumamoto, Japan.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Noda
authors.affiliation: Kumamoto Chuo Hospital, Kumamoto, Japan.
authors.forename: Mina
authors.initials: M
authors.lastname: Okubo
authors.affiliation: Kumamoto Municipal Ueki Hospital, Kumamoto, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Ichimori
authors.affiliation: Minamata City Hospital and Medical Center, Kumamoto, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Fujisawa
authors.affiliation: Kumamoto General Hospital, Japan Community Healthcare Organization, Kumamoto, Japan.
authors.forename: Makiko
authors.initials: M
authors.lastname: Fukunaga
authors.affiliation: Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Eiichi
authors.initials: E
authors.lastname: Araki
mesh_terms: D000368:Aged; D044466:Asian People; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069057:Insulin Detemir / Q000009:adverse effects / Q000627:therapeutic use*; D000069036:Insulin Glargine / Q000009:adverse effects / Q000627:therapeutic use*; D049528:Insulin, Long-Acting / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069057:Insulin Detemir; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; C517652:hemoglobin A1c protein, human; C571886:insulin degludec
keywords: Insulin degludec; Insulin detemir; Insulin glargine