title: Efficacy and Safety of Ipragliflozin in Japanese Patients With Type 2 Diabetes: Interim Outcome of the ASSIGN-K Study.
abstract: BACKGROUND
  Ipragliflozin is a sodium-glucose co-transporter 2 inhibitor that can improve glycemic control and reduce body weight and blood pressure in patients with type 2 diabetes mellitus (T2DM). We evaluated the efficacy and safety of ipragliflozin in the real-world clinical setting, with a focus on the changes of body composition up to 3 months of treatment.
  
  
  METHODS
  This was a prospective multicenter interventional trial. We investigated changes of the blood pressure, body composition, blood glucose, hemoglobin A1c (HbA1c), ketone bodies, lipids, and insulin after treatment with ipragliflozin (50 - 100 mg/day) for 12 weeks in Japanese patients with T2DM who showed poor glycemic control despite receiving diet and exercise therapy with or without oral antidiabetic drugs for more than 12 weeks.
  
  
  RESULTS
  Two hundred and fifty-seven subjects were included in the efficacy analysis up to 12 weeks of treatment and 301 subjects were included in the safety analysis. From baseline to 12 weeks, HbA1c showed a change of -0.68% (95% confidence interval (CI): -0.83, -0.53) and fasting blood glucose showed a change of -23.9 mg/dL (95% CI: -30.5, -17.2), with both parameters displaying a significant reduction (P < 0.001). The difference of body weight from baseline was -1.82 kg (95% CI: -2.14, -1.50), and it also showed significant reduction (P < 0.001). Analysis of body composition revealed that body fat changed by -1.46 kg (95% CI: -1.79, -1.14, P < 0.001) and body water changed by -0.37 kg (95% CI: -0.60, -0.14, P < 0.01). Laboratory tests demonstrated improvement of liver function and the lipid profile. Adverse events (AEs) occurred in 22.6% of the subjects, with frequent events being vulvovaginal candidiasis in 2.7% and cystitis in 2.0%. Serious AEs occurred in three subjects.
  
  
  CONCLUSIONS
  In patients with T2DM, ipragliflozin improved glycemic control after 1 month of treatment and caused weight loss by reducing body fat more than body water.
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Iizuka
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Kotaro
authors.initials: K
authors.lastname: Iemitsu
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Takihata
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Takai
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Nakajima
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Minami
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Umezawa
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Kanamori
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Takeda
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Takehiro
authors.initials: T
authors.lastname: Kawata
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Shogo
authors.initials: S
authors.lastname: Ito
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Taisuke
authors.initials: T
authors.lastname: Kikuchi
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Hikaru
authors.initials: H
authors.lastname: Amemiya
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Mizuki
authors.initials: M
authors.lastname: Kaneshiro
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Atsuko
authors.initials: A
authors.lastname: Mokubo
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Takuma
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Machimura
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Keiji
authors.initials: K
authors.lastname: Tanaka
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Taro
authors.initials: T
authors.lastname: Asakura
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Kubota
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Sachio
authors.initials: S
authors.lastname: Aoyagi
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Hoshino
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Masashi
authors.initials: M
authors.lastname: Ishikawa
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Matsuzawa
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Obana
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Nobuo
authors.initials: N
authors.lastname: Sasai
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Kaneshige
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Fuyuki
authors.initials: F
authors.lastname: Minagawa
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Saito
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Shinoda
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Miyakawa
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan; Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kanagawa, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: Department of Endocrinology and Diabetes, Yokohama City University Medical Center, Kanagawa, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Terauchi
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Ikuro
authors.initials: I
authors.lastname: Matsuba
keywords: Antidiabetic agent; Body composition; Ipragliflozin; Sodium-glucose co-transporter 2 inhibitor; Type 2 diabetes mellitus