PMID- 28811858
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 1918-3003 (Print)
IS  - 1918-3011 (Electronic)
IS  - 1918-3003 (Linking)
VI  - 9
IP  - 9
DP  - 2017 Sep
TI  - Effectiveness of Ipragliflozin for Reducing Hemoglobin A1c in Patients With a 
      Shorter Type 2 Diabetes Duration: Interim Report of the ASSIGN-K Study.
PG  - 793-801
LID - 10.14740/jocmr3116w [doi]
AB  - BACKGROUND: Ipragliflozin is a selective sodium glucose co-transporter 2 
      inhibitor. The ASSIGN-K study is investigating the efficacy and safety of 
      ipragliflozin for type 2 diabetes mellitus (T2DM) in the real-world clinical 
      setting. METHODS: Japanese T2DM patients with inadequate glycemic control despite 
      diet and exercise with/without pharmacotherapy were enrolled in an 
      investigator-driven, multicenter, prospective, observational study examining the 
      efficacy and safety of ipragliflozin treatment (50 mg/day for 52 weeks). We 
      performed interim analysis after 24 weeks. RESULTS: In 367 patients completing 
      24-week ipragliflozin therapy, hemoglobin A1c (HbA1c) decreased significantly 
      from 8.07% at baseline to 7.26% in week 24 (P < 0.001). The change in HbA1c from 
      treatment initiation to week 24 was -0.88% in patients < 65 years old versus 
      -0.55% in those >/= 65 years and -0.92% in men versus -0.70% in women (all P < 
      0.001). When baseline HbA1c was < 7%, 7% to < 8%, and >/= 8%, the change was 
      -0.18%, -0.45%, and -1.48%, respectively (P = 0.5352, P < 0.001, and P < 0.001, 
      respectively). When baseline body mass index (BMI) was < 25, 25 to < 30, and >/= 
      30, the change was -1.05%, -0.65%, and -0.87%, respectively (all P < 0.001). 
      Multiple regression analysis showed that HbA1c decreased more in patients with a 
      higher baseline HbA1c or shorter duration of diabetes. An HbA1c < 7% was achieved 
      in 33.3% of the patients, and their baseline HbA1c was significantly lower than 
      that of patients failing to achieve it (P < 0.001). Adverse events (AEs) occurred 
      in 106/451 patients (23.5%), including 29.1% of patients aged 65 or older. Common 
      AEs were vulvovaginal candidiasis (3.1%) and genital pruritus (1.8%). Serious AEs 
      included urinary tract infection, unstable angina, and ketosis, which occurred in 
      patients who did not suspend medication during acute illness. CONCLUSIONS: 
      Ipragliflozin significantly improved HbA1c in T2DM patients with inadequate 
      glycemic control. Improvement in HbA1c was significant irrespective of age, sex, 
      baseline HbA1c, or BMI, but efficacy was greater with a higher baseline HbA1c and 
      shorter duration of diabetes. For safe continuation of treatment, patients should 
      be advised to suspend medication during acute illness.
FAU - Iemitsu, Kotaro
AU  - Iemitsu K
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Kawata, Takehiro
AU  - Kawata T
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Iizuka, Takashi
AU  - Iizuka T
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Takihata, Masahiro
AU  - Takihata M
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Takai, Masahiko
AU  - Takai M
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Nakajima, Shigeru
AU  - Nakajima S
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Minami, Nobuaki
AU  - Minami N
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Umezawa, Shinichi
AU  - Umezawa S
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Kanamori, Akira
AU  - Kanamori A
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Takeda, Hiroshi
AU  - Takeda H
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Ito, Shogo
AU  - Ito S
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Kikuchi, Taisuke
AU  - Kikuchi T
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Amemiya, Hikaru
AU  - Amemiya H
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Kaneshiro, Mizuki
AU  - Kaneshiro M
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Mokubo, Atsuko
AU  - Mokubo A
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Takuma, Tetsuo
AU  - Takuma T
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Machimura, Hideo
AU  - Machimura H
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Tanaka, Keiji
AU  - Tanaka K
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Asakura, Taro
AU  - Asakura T
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Kubota, Akira
AU  - Kubota A
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Aoyanagi, Sachio
AU  - Aoyanagi S
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Hoshino, Kazuhiko
AU  - Hoshino K
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Ishikawa, Masashi
AU  - Ishikawa M
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Matsuzawa, Yoko
AU  - Matsuzawa Y
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Obana, Mitsuo
AU  - Obana M
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Sasai, Nobuo
AU  - Sasai N
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Kaneshige, Hideaki
AU  - Kaneshige H
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Minagawa, Fuyuki
AU  - Minagawa F
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Saito, Tatsuya
AU  - Saito T
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Shinoda, Kazuaki
AU  - Shinoda K
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Miyakawa, Masaaki
AU  - Miyakawa M
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
FAU - Tanaka, Yasushi
AU  - Tanaka Y
AD  - Department of Internal Medicine, Division of Metabolism and Endocrinology, St. 
      Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, 
      Kanagawa 216-8511, Japan.
FAU - Terauchi, Yasuo
AU  - Terauchi Y
AD  - Department of Molecular Endocrinology and Diabetes Internal Medicine, Yokohama 
      City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, 
      Yokohama-shi, Kanagawa 236-0004, Japan.
FAU - Matsuba, Ikuro
AU  - Matsuba I
AD  - Diabetes Committee, Kanagawa Physicians Association, 3-1 Fujimi-cho, Naka-ku, 
      Yokohama-shi, Kanagawa 231-0037, Japan.
LA  - eng
PT  - Journal Article
DEP - 20170727
PL  - Canada
TA  - J Clin Med Res
JT  - Journal of clinical medicine research
JID - 101538301
PMC - PMC5544486
OTO - NOTNLM
OT  - Body fat mass
OT  - Glycemic control
OT  - Ipragliflozin
OT  - Sodium glucose co-transporter 2 inhibitor
OT  - Type 2 diabetes mellitus
EDAT- 2017/08/16 06:00
MHDA- 2017/08/16 06:01
PMCR- 2017/07/27
CRDT- 2017/08/17 06:00
PHST- 2017/05/25 00:00 [received]
PHST- 2017/06/13 00:00 [accepted]
PHST- 2017/08/17 06:00 [entrez]
PHST- 2017/08/16 06:00 [pubmed]
PHST- 2017/08/16 06:01 [medline]
PHST- 2017/07/27 00:00 [pmc-release]
AID - 10.14740/jocmr3116w [doi]
PST - ppublish
SO  - J Clin Med Res. 2017 Sep;9(9):793-801. doi: 10.14740/jocmr3116w. Epub 2017 Jul 
      27.