title: Factors Predicting Therapeutic Efficacy of Combination Treatment With Sitagliptin and Insulin in Type 2 Diabetic Patients: The ASSIST-K Study.
abstract: BACKGROUND
  It is unclear whether dipeptidyl peptidase-4 inhibitors decrease hemoglobin A1c (HbA1c) in a glucose-dependent manner in patients on insulin therapy who have impaired insulin secretion. This study investigated factors influencing the efficacy of sitagliptin when used concomitantly with insulin to treat type 2 diabetes mellitus (T2DM) in the real-world setting.
  
  
  METHODS
  A retrospective study was conducted of 1,004 T2DM patients at 36 Japanese clinics associated with the Diabetes Task Force of the Kanagawa Physicians Association. Eligible patients had been on insulin for at least 6 months, with a baseline HbA1c of 7.0% (53 mmol/mol) or higher. Baseline characteristics and laboratory data from 495 patients were subjected to multiple regression analysis to identify factors influencing the change of HbA1c.
  
  
  RESULTS
  Most patients (n = 809) received sitagliptin at a dose of 50 mg. In the 1,004 patients, HbA1c decreased by 0.74% (6 mmol/mol) and body weight increased by 0.1 kg after 6 months of combination therapy. Multiple regression analysis showed that a higher baseline HbA1c, older age, and lower body mass index influenced the change of HbA1c after 6 months. Hypoglycemic symptoms occurred in 7.4%, but none were severe.
  
  
  CONCLUSIONS
  These results emphasize the importance of a higher HbA1c at the commencement of sitagliptin therapy in patients on insulin. Glucose-dependent suppression of glucagon secretion by sitagliptin may be useful in patients with impaired insulin secretion. Sitagliptin can be used concomitantly with insulin irrespective of the insulin regimen, duration of insulin treatment, and concomitant medications.
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Masashi
authors.initials: M
authors.lastname: Ishikawa
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Takai
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Hajime
authors.initials: H
authors.lastname: Maeda
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Kanamori
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Kubota
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Hikaru
authors.initials: H
authors.lastname: Amemiya
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Iizuka
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Kotaro
authors.initials: K
authors.lastname: Iemitsu
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Iwasaki
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Goro
authors.initials: G
authors.lastname: Uehara
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Umezawa
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Obana
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Kaneshige
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Mizuki
authors.initials: M
authors.lastname: Kaneshiro
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Takehiro
authors.initials: T
authors.lastname: Kawata
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Nobuo
authors.initials: N
authors.lastname: Sasai
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Saito
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Takuma
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Takeda
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Keiji
authors.initials: K
authors.lastname: Tanaka
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Tsurui
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Nakajima
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Hoshino
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Shin
authors.initials: S
authors.lastname: Honda
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Hideo
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authors.lastname: Machimura
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Kiyokazu
authors.initials: K
authors.lastname: Matoba
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Fuyuki
authors.initials: F
authors.lastname: Minagawa
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Minami
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Miyairi
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Atsuko
authors.initials: A
authors.lastname: Mokubo
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Motomiya
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Manabu
authors.initials: M
authors.lastname: Waseda
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Miyakawa
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Naka
authors.affiliation: Department of Endocrinology and Metabolism, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Terauchi
authors.affiliation: Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki City, Kanagawa 216-8511, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: The Study Group of the Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, Yokoyama City, Kanagawa 231-0037, Japan.
authors.forename: Ikuro
authors.initials: I
authors.lastname: Matsuba
keywords: Body weight; Combination therapy; HbA1c; Insulin; Multiple regression analysis; Sitagliptin; Type 2 diabetes