title: Sitagliptin monotherapy has better effect on insulinogenic index than glimepiride monotherapy in Japanese patients with type 2 diabetes mellitus: a 52-week, multicenter, parallel-group randomized controlled trial.
abstract: BACKGROUND
  The 52-week monotherapy with the dipeptidyl peptidase-4 inhibitor sitagliptin and the sulphonylurea glimepiride on early-phase insulin secretion in Japanese patients with type 2 diabetes mellitus (T2DM) is not known.
  
  
  METHODS
  A randomized, parallel-group, open-label trial was conducted at 18 centers between February, 2011 and March, 2013. 171 outpatients with T2DM were recruited and randomly assigned to glimepiride or sitagliptin by minimization. Doses of glimepiride (0.25-1.0 mg/day) and sitagliptin (25-100 mg/day) were adjusted for hemoglobin A1c (HbA1c) > 6.9 %. Analyses were performed on full analysis set (FAS) of randomized subjects taking medications as allocated, and underwent 75 g oral glucose tolerance test (OGTTs) before and after treatment. The primary outcome was insulinogenic index to quantify early-phase insulin secretion after treatment, which was evaluated by analysis of covariance (ANCOVA).
  
  
  RESULTS
  Of 171 enrolled subjects, 68 in the sitagliptin group and 65 in the glimepiride group were included in the FAS (mean age, 64 years; baseline (HbA1c), 7.4 %). The primary outcome revealed a significantly higher insulinogenic index in the sitagliptin group than that in the glimepiride group (p = 0.036). Sitagliptin also reduced plasma glucose levels at 60 and 120 min during OGTT compared with glimepiride, while achieving a similar improvement in HbA1c during treatment. Body weight did not change in either of the two groups, and one case of hypoglycemia was observed in the glimepiride group.
  
  
  CONCLUSIONS
  Sitagliptin shows better effects on insulinogenic index after 52-week treatment compared with glimepiride in Japanese patients with T2DM. Trial registration University hospital Medical Information Network (UMIN) Clinical Trials Registry, No.00004791.
authors.affiliation: Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507 Japan ; Department of Internal Medicine, Kyoto Kizugawa Hospital, Joyo, Japan.
authors.forename: Yaeko
authors.initials: Y
authors.lastname: Kondo
authors.affiliation: Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507 Japan ; Nagisa Clinic, Hirakata, Japan.
authors.forename: Norio
authors.initials: N
authors.lastname: Harada
authors.affiliation: Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507 Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Hamasaki
authors.affiliation: Division of Diabetes/Endocrinology/Lifestyle-related Disease, Takatsuki Red Cross Hospital, Takatsuki, Japan.
authors.forename: Shizuka
authors.initials: S
authors.lastname: Kaneko
authors.affiliation: Department of Diabetology and Endocrinology, Osaka Saiseikai Noe Hospital, Osaka, Japan.
authors.forename: Koichiro
authors.initials: K
authors.lastname: Yasuda
authors.affiliation: Department of Diabetes and Endocrinology, Shiga Medical Center for Adults, Moriyama, Japan.
authors.forename: Eiichi
authors.initials: E
authors.lastname: Ogawa
authors.affiliation: Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507 Japan.
authors.forename: Shin-Ichi
authors.initials: S
authors.lastname: Harashima
authors.affiliation: Department of Diabetes Mellitus, The Japan Baptist Medical Foundation, The Japan Baptist Hospital, Kyoto, Japan.
authors.forename: Hiroko
authors.initials: H
authors.lastname: Yoneda
authors.affiliation: Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507 Japan ; Nishio Clinic, Uji, Japan.
authors.forename: Yoshihito
authors.initials: Y
authors.lastname: Fujita
authors.affiliation: Department of Internal Medicine, Hyogo Prefectural Tsukaguchi Hospital, Amagasaki, Japan.
authors.forename: Norikazu
authors.initials: N
authors.lastname: Kitano
authors.affiliation: Division of Diabetes and Endocrinology, Department of Internal Medicine, Hyogo Prefectural Amagasaki Hospital, Amagasaki, Japan.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Nakamura
authors.affiliation: Statcom Company Limited, Bunkyo-Ku, Japan.
authors.forename: Fujio
authors.initials: F
authors.lastname: Matsuo
authors.affiliation: Statcom Company Limited, Bunkyo-Ku, Japan.
authors.forename: Megumi
authors.initials: M
authors.lastname: Shinji
authors.affiliation: Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.
authors.forename: Shiro
authors.initials: S
authors.lastname: Hinotsu
authors.affiliation: Department of Health Informatics, School of Public Health, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors.forename: Takeo
authors.initials: T
authors.lastname: Nakayama
authors.affiliation: Department of Diabetes, Endocrinology and Nutrition, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507 Japan.
authors.forename: Nobuya
authors.initials: N
authors.lastname: Inagaki
keywords: Clinical trial; DPP-4 inhibitor; Insulin secretion; Sulphonylurea; Type 2 diabetes