Safety and efficacy of canagliflozin in Japanese patients with type 2 diabetes mellitus: post hoc subgroup analyses according to body mass index in a 52-week open-label study

Abstract

Background: The safety and efficacy of sodium glucose co-transporter 2 inhibitors in non-obese compared with obese patients with type 2 diabetes mellitus is unknown.

Methods: We conducted post hoc analyses of the results of a 52-week open-label study of Japanese type 2 diabetes mellitus patients treated with 100 or 200 mg canagliflozin. Patients were divided into four subgroups according to their baseline body mass index (BMI): group I, BMI < 22 kg/m²; group II, BMI ≥ 22 to < 25 kg/m²; group III, BMI ≥ 25 to < 30 kg/m² and group IV, BMI ≥ 30 kg/m².

Results: The overall safety was similar among the four BMI subgroups, although there were slight differences in terms of the incidences of hypoglycemia, asymptomatic hypoglycemia, female genital infections and proportions of patients with total ketone body levels exceeding 1000 μmol/l at any time for both canagliflozin doses. Hemoglobin A1c, fasting plasma glucose and body weight decreased significantly from baseline to week 52 at both canagliflozin doses. The changes in hemoglobin A1c, and fasting plasma glucose were not significantly different among the four BMI subgroups for either dose.

Conclusion: Canagliflozin was tolerated in patients irrespective of their BMI at the start of treatment, although some caution may be needed.

Keywords:

• body mass index
• canagliflozin
• Japanese
• safety
• type 2 diabetes mellitus

Author contributions

N Inagaki supervised the design and protocol of the study, and contributed to the interpretation and discussion of the results. N Maruyama contributed to the development of the protocol and the design, and prepared the data. S Yokota contributed to the data processing and statistical analysis. M Goda and H Iijima contributed to the preparation of the outline of the paper, and the interpretation and discussion of the data. All authors contributed to manuscript preparation and have approved the final draft.

Declaration of interest

N Inagaki has received consulting fees and research support from and has served on speakers bureaus for Mitsubishi Tanabe Pharma Corp.; has received consulting fees and/or research support from Astellas Pharma Inc., AstraZeneca K.K., Bristol-Myers K.K., Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., GlaxoSmithKline K.K., Japan Tobacco Inc., Kissei Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., MSD K.K., Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma K.K., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Pfizer Japan Inc., Roche Diagnostics K.K., Sanofi K.K., Shiratori Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Taisho Pharmaceutical Co., Ltd. and Takeda Pharmaceutical Co., Ltd.; and has served on speakers bureaus for AstraZeneca K.K., Daiichi Sankyo Co., Ltd., Kowa Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., MSD K.K., Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma K.K., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Sanofi K.K., Sumitomo Dainippon Pharma Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd. and Takeda Pharmaceutical Co., Ltd. All other authors are employees of Mitsubishi Tanabe Pharma Corp. Canagliflozin was developed by Mitsubishi Tanabe Pharma Corp. in collaboration with Janssen Research & Development, LLC. This study was funded by Mitsubishi Tanabe Pharma Corp. The authors thank ND Smith, PhD, for providing editorial support, which was funded by Mitsubishi Tanabe Pharma Corp. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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