Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A subanalysis of a post‐marketing study (J‐STEP/EL Study)

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Abstract

Aims/Introduction

This subanalysis aimed to assess the safety and effectiveness of tofogliflozin by using data from the Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients in an Observational Study of the Elderly to categorize elderly Japanese patients with type 2 diabetes mellitus by the number of concomitant oral antidiabetic drugs (OADs) and insulin use at baseline.

Materials and Methods

Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients in an Observational Study of the Elderly is a 1‐year prospective, observational and multicenter post‐marketing study that enrolled all patients with type 2 diabetes mellitus aged ≥65 years who started tofogliflozin during the first 3 months after its launch in May 2014 in Japan.

Results

The safety and effectiveness analysis sets included 1,497 and 1,422 patients, respectively. Overall, 18.10 and 2.20% of the patients experienced adverse drug reactions (ADRs) and serious ADRs, respectively. ADRs of special interest in the total, 0 OAD, one OAD, two OADs, three or more OADs and insulin groups occurred in 12.22, 10.04, 12.35, 13.32, 11.27 and 14.91% of patients, respectively. Volume depletion‐related events were the most frequently observed ADRs of special interest. Hypoglycemia occurred in 1.07% of patients. Overall, glycated hemoglobin and bodyweight were significantly decreased, but the estimated glomerular filtration rate was not significantly changed.

Conclusions

Our finding suggests that tofogliflozin could be safely and effectively used in elderly Japanese patients with type 2 diabetes mellitus, irrespective of the number of OADs and the use of insulin.

Abstract

This subanalysis suggests that tofogliflozin could be safely and effectively used in elderly Japanese patients with type 2 diabetes mellitus in a real‐world clinical setting irrespective of the numbers of oral antidiabetic drugs and insulin use.

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Most cited references 28

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Diabetes in older adults: a consensus report.

M. Sue Kirkman, Vanessa Briscoe, Nathaniel Clark … (2012)

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Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities.

N. N. Zammitt, B. Frier (2005)

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Is Open Access

Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus: a combined Phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study

Kohei Kaku, Hirotaka Watada, Yasuhiko Iwamoto … (2014)

Background In recent years, several oral antidiabetic drugs with new mechanisms of action have become available, expanding the number of treatment options. Sodium/glucose cotransporter-2 (SGLT2) inhibitors are a new class of oral antidiabetic drugs with an insulin-independent mechanism promoting urinary glucose excretion. We report the results of a combined Phase 2 and 3 clinical study (Japic CTI-101349) of the SGLT2 inhibitor tofogliflozin (CSG452, RG7201) in Japanese patients with type 2 diabetes mellitus. Methods The efficacy and safety of tofogliflozin were assessed in this multicenter, placebo-controlled, randomized, double-blind parallel-group study involving 230 patients with type 2 diabetes mellitus with inadequate glycemic control on diet/exercise therapy. Between 30 October 2010 and 28 February 2012, patients at 33 centers were randomized to either placebo (n = 56) or tofogliflozin (10, 20, or 40 mg; n = 58 each) orally, once daily for 24 weeks. The primary efficacy endpoint was the change from baseline in HbA1c at week 24. Results Overall, 229 patients were included in the full analysis set (placebo: n = 56; tofogliflozin 10 mg: n = 57; tofogliflozin 20 and 40 mg: n = 58 each). The least squares (LS) mean change (95% confidence interval) from baseline in HbA1c at week 24 was −0.028% (−0.192 to 0.137) in the placebo group, compared with −0.797% (−0.960 to −0.634) in the tofogliflozin 10 mg group, −1.017% (−1.178 to −0.856) in the tofogliflozin 20 mg group, and −0.870% (−1.031 to −0.709) in the tofogliflozin 40 mg group (p < 0.0001 for the LS mean differences in all tofogliflozin groups vs placebo). There were also prominent decreases in fasting blood glucose, 2-h postprandial glucose, and body weight in all tofogliflozin groups compared with the placebo group. The main adverse events were hyperketonemia, ketonuria, and pollakiuria. The incidence of hypoglycemia was low. Furthermore, most adverse events were classified as mild or moderate in severity. Conclusions Tofogliflozin 10, 20, or 40 mg administered once daily as monotherapy significantly decreased HbA1c and body weight, and was generally well tolerated in Japanese patients with type 2 diabetes mellitus. Phase 3 studies were recently completed and support the findings of this combined Phase 2 and 3 study. Trial registration This study was registered in the JAPIC clinical trials registry (ID: Japic CTI-101349).

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Author and article information

Contributors

Kohei Kaku:

ORCID: https://orcid.org/0000-0003-1574-0565

kka@med.kawasaki-m.ac.jp

Journal

Journal ID (nlm-ta): J Diabetes Investig

Journal ID (iso-abbrev): J Diabetes Investig

Journal ID (doi): 10.1111/(ISSN)2040-1124

Journal ID (publisher-id): JDI

Title: Journal of Diabetes Investigation

Publisher: John Wiley and Sons Inc. (Hoboken )

ISSN (Print): 2040-1116

ISSN (Electronic): 2040-1124

Publication date (Electronic): 05 September 2019

Publication date (Print): March 2020

Volume: 11

Issue: 2 ( doiID: 10.1111/jdi.v11.2 )

Pages: 405-416

Affiliations

[ ¹ ] Department of Medicine Kawasaki Medical School Kurashiki Japan

[ ² ] Diabetes & Cardiovascular Medical Operations Sanofi K.K. Tokyo Japan

[ ³ ] Medical Affairs Sanofi K.K. Tokyo Japan

[ ⁴ ] Post Marketing Surveillance Department Kowa Company, Ltd. Nagoya Japan

[ ⁵ ] Center for Preventive Medicine The Jikei University School of Medicine Tokyo Japan

Author notes

[*] [* ] Correspondence

Kohei Kaku

Tel.: +81‐86‐462‐1111

Fax: +81‐86‐462‐7897

E‐mail address: kka@ 123456med.kawasaki-m.ac.jp

Author information

Kohei Kaku https://orcid.org/0000-0003-1574-0565

Masayuki Senda https://orcid.org/0000-0001-6673-1429

Yuji Kurihara https://orcid.org/0000-0002-3464-0669

Article

Publisher ID: JDI13125

DOI: 10.1111/jdi.13125

PMC ID: 7078101

PubMed ID: 31390166

SO-VID: 84d87a4b-1768-4634-ad05-25dfa86aa0cb

License:

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

History

Date received : 31 March 2019

Date revision received : 18 July 2019

Date accepted : 29 July 2019

Page count

Figures: 1, Tables: 4, Pages: 12, Words: 11219

Funding

Funded by: Kowa Company, Ltd.

Funded by: Sanofi K.K.

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cover-date March 2020

details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.8 mode:remove_FC converted:17.03.2020

Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A subanalysis of a post‐marketing study (J‐STEP/EL Study)

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Most cited references 28

Diabetes in older adults: a consensus report.

Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities.

Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus: a combined Phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study

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