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Ipragliflozin improves glycemic control in Japanese patients with type 2 diabetes mellitus: the BRIGHTEN study

BRIGHTEN: double-blind randomized study of ipragliflozin to show its efficacy as monotherapy in T2DM patients

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Abstract

Ipragliflozin is a sodium–glucose co-transporter 2 inhibitor under clinical development for treating type 2 diabetes mellitus (T2DM). In this Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, 129 Japanese patients with T2DM were randomized to either 50 mg ipragliflozin (n = 62) or placebo (n = 67) once daily for 16 weeks. Hemoglobin A1c (HbA1c) levels decreased significantly from baseline to the end of treatment in the ipragliflozin group (−0.76 %) but increased in the placebo group (+0.54 %), resulting in a placebo-adjusted mean change from baseline of −1.24 % (P < 0.001). Fasting plasma glucose (FPG) levels also decreased significantly in the ipragliflozin group (−40.2 mg/dL) but not in the placebo group (+6.3 mg/dL). The changes in body weight (−2.31 kg vs. −1.03 kg, P < 0.001) and waist circumference (−1.61 cm vs. −0.41 cm, P = 0.028) from baseline to the end of treatment were significantly greater in the ipragliflozin group than in the placebo group. Treatment-emergent adverse events occurred in 53.2 % and 59.7 % of patients in the ipragliflozin and placebo groups, respectively. All of the events were mild to moderate in severity. Hypoglycemia (ipragliflozin vs. placebo 1.6 % vs. 0 %), genital infections (3.2 % vs. 0 %), and urinary tract infection (0 % vs. 1.5 %) were rare. In conclusion, treatment with 50 mg ipragliflozin once daily for 16 weeks achieved significant improvements in HbA1c, FPG, body weight, and waist circumference compared with placebo in Japanese patients with T2DM. Ipragliflozin was well tolerated with low rates of genital infection and hypoglycemia.

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Acknowledgments

The authors thank Kathy Boon, PhD from Excerpta Medica, Nicholas D. Smith, PhD, and ELMCOM™ for providing writing/editorial assistance for this work, which was supported by Astellas Pharma Inc.

Conflict of interest

Ipragliflozin (ASP1941) is under development by Astellas Pharma Inc. and Kotobuki Pharmaceutical Co., Ltd. A. Kashiwagi is a consultant for and has received consulting fees/honoraria from Astellas Pharma Inc. K. Kazuta, Y. Takinami, S. Yoshida, A. Utsuno, and I. Nagase are employees of Astellas Pharma Inc., Tokyo, Japan.

Author information

Authors and Affiliations

  1. Shiga University of Medical Science, Shiga, Japan

    Atsunori Kashiwagi

  2. Astellas Pharma Inc., 3-17-1 Hasune, Itabashi, Tokyo, 174-8612, Japan

    Kenichi Kazuta, Yuusuke Takinami, Satoshi Yoshida, Atsushi Utsuno & Itsuro Nagase

Authors
  1. Atsunori Kashiwagi
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  2. Kenichi Kazuta
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  3. Yuusuke Takinami
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  4. Satoshi Yoshida
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  5. Atsushi Utsuno
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  6. Itsuro Nagase
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Corresponding author

Correspondence to Kenichi Kazuta.

Additional information

ClinicalTrials.gov identifier: NCT01057628.

Primary investigators

Primary investigators

Hiroki Yokoyama (Jiyugaoka Medical Clinic, Internal Medicine), Hiroaki Seino (Seino Internal Medicine Clinic), Kouichi Kawai (Medical Corporation TDC Kawai Clinic), Hiroyuki Asano and Hideto Ishii (Asano Internal Medicine Clinic, Medical Corporation Yukeikai), Tsuyoshi Yamato (Kouwa Clinic, Medical Corporation Kouwakai), Koutaro Fujimoto (Fujimoto Clinic), Bunrei Goto (Medical Corporation Gotou Medical Clinic), Makoto Kunisaki (Kunisaki Makoto Clinic, Medical Corporation Shinaikai), Hideaki Jinnouchi (Jinnouchi Hospital), Yoshiharu Kitakaze (Takamori Clinic), Tomio Tsukazaki (Aozora Total Clinic), Yoichi Wakana (Kabashima Hospital), Takaaki Iwai (Sagamino Central Hospital), Fuyuki Minagawa (Minagawa Internal Medicine Clinic), Ichitaro Takada (Takada Internal Medicine Clinic), Noboru Miyachi (Miyachi Internal Medicine Clinic), Toru Takeuchi (Hokusetsu General Hospital, Medical Corporation Senyoukai), Takehiko Kobayashi (Kobayashi Shinryosho), Kunihiro Ekawa (Saiseikai Wakayama Hospital), Mitsuru Ozaki (Kitade Hospital), Kunihiko Nakamura (Tenjingawa Nakamura Medical Clinic), Yoshio Ohashi (Tokyo Ekimae-building Clinic).

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Kashiwagi, A., Kazuta, K., Takinami, Y. et al. Ipragliflozin improves glycemic control in Japanese patients with type 2 diabetes mellitus: the BRIGHTEN study. Diabetol Int 6, 8–18 (2015). https://doi.org/10.1007/s13340-014-0164-0

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  • DOI: https://doi.org/10.1007/s13340-014-0164-0

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