title: Efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes.
abstract: BACKGROUND
  The aim of this study was to investigate the clinical efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes.
  
  
  METHODS
  A total of 3,247 subjects treated with sitagliptin were retrospectively recruited. Glucose parameters were collected at baseline, and 1, 3 and 6 months after initiation of sitagliptin. In addition, we explored factors that can be used to predict sitagliptin-induced reduction in HbA1c using linear mixed effect model. Factors associated with hypoglycemic events were examined by logistic analyses.
  
  
  RESULTS
  We analyzed the available data of 3,201 subjects (1,287 females). Treatment of sitagliptin significantly reduced HbA1c level from 7.44±1.20% at baseline to 6.73±0.99% at 6 months (P < 0.0001). Linear mixed effect model analyses demonstrated that reduction of HbA1c was associated with higher baseline HbA1c level, younger age, lower BMI and sitagliptin monotherapy. During this study, 82 cases of hypoglycemia were recorded. Logistic analyses indicated that hypoglycemic events were more frequent in female patients, and patients with low BMI, long history of type 2 diabetes, high HbA1c and on combination therapy experienced. Other adverse events were rare and mild.
  
  
  CONCLUSIONS
  Sitagliptin is effective for diabetic management and generally well tolerated in Japanese patients with type 2 diabetes. This trial was registered with UMIN (no. 000004121).
authors.affiliation: Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo 113-8421, Japan.
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Ohmura
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo 113-8421, Japan.
authors.forename: Tomoya
authors.initials: T
authors.lastname: Mita
authors.affiliation: Taneda Clinic, Iwaki, Fukushima 973-8402, Japan.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Taneda
authors.affiliation: Sugawara Medical Clinic, Tokyo 177-0041, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Sugawara
authors.affiliation: Funayama Clinic, Tokyo 135-0047, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Funayama
authors.affiliation: Department Center for Lifetime Cancer Education, Juntendo University Graduate School of Medicine, Tokyo 113-0033, Japan.
authors.forename: Joe
authors.initials: J
authors.lastname: Matsuoka
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo 113-8421, Japan.
authors.forename: Hirotaka
authors.initials: H
authors.lastname: Watada
authors.affiliation: Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo 113-8421, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Daida
keywords: DPP-4 inhibitor; Treatment efficacy; Treatment safety