title: Factors Influencing Changes in Hemoglobin A1c and Body Weight During Treatment of Type 2 Diabetes With Ipragliflozin: Interim Analysis of the ASSIGN-K Study.
abstract: BACKGROUND
  Ipragliflozin is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor that blocks glucose reabsorption in the proximal tubules. SGLT2 inhibitors are expected to be effective in patients with insulin resistance and obesity, but it is important to select treatment according to patient background factors that minimizes the risk of adverse events. There have been a limited number of investigations into the relationship between the clinical efficacy (reducing hemoglobin A1c (HbA1c) and body weight (BW)) or safety of SGLT2 inhibitors and patient characteristics.
  
  
  METHODS
  ASSIGN-K is an investigator-initiated, multicenter, prospective observational study examining the efficacy and safety of ipragliflozin (50 - 100 mg/day for 52 weeks) in Japanese patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with HbA1c ≥ 6.0% (National Glycohemoglobin Standardization Program) despite diet and exercise therapy or diet and exercise plus antidiabetic drug therapy. We conducted an interim analysis of the relationship between changes in HbA1c or BW and characteristics in patients who had been on treatment for more than 12 weeks.
  
  
  RESULTS
  In 257 patients completing 12 weeks of treatment, HbA1c decreased significantly from 8.23% to 7.55% (-0.68%, P < 0.01). The change in HbA1c after 12 weeks was -0.17%, -0.33%, and -1.16% when baseline HbA1c was < 7%, 7% to < 8%, and ≥ 8%, respectively (P < 0.05, P < 0.01, and P < 0.01, respectively), and -1.30%, -0.62%, and -0.62% when baseline body mass index (BMI) was < 25, 25 to < 30, and ≥ 30, respectively (all P < 0.01). Stratified analysis showed that age, gender, or BMI did not have a significant influence on the improvement in HbA1c. Multiple regression analysis showed that reduction in HbA1c was greater as baseline HbA1c increased and the duration of diabetes decreased. A higher baseline HbA1c was associated with less weight loss.
  
  
  CONCLUSIONS
  Ipragliflozin significantly improved HbA1c in patients with T2DM. HbA1c improved more when baseline HbA1c was higher and the duration of diabetes was shorter, suggesting that current treatment policies for diabetes could be re-examined.
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Kotaro
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authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Takashi
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authors.lastname: Iizuka
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Masahiro
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authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Masahiko
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authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Shigeru
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authors.lastname: Nakajima
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Nobuaki
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authors.lastname: Minami
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Shinichi
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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
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authors.lastname: Kawata
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Shogo
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authors.lastname: Ito
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Taisuke
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authors.lastname: Kikuchi
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Hikaru
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authors.lastname: Amemiya
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Mizuki
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authors.lastname: Kaneshiro
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Atsuko
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authors.lastname: Mokubo
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Tetsuro
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authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Hideo
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authors.lastname: Machimura
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Keiji
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authors.lastname: Tanaka
authors.affiliation: Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Taro
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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
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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: 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: 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: Body weight; Hemoglobin A1c; Interim analysis; Ipragliflozin; Patient characteristics; Selective sodium glucose co-transporter 2 inhibitor; Type 2 diabetes