You are here

  • Home
  • Archive
  • Volume 8, Issue 2
  • Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND): study design and baseline characteristics of patients with type 2 diabetes newly initiating oral antidiabetic drug monotherapy in Japan

Article Text

Article menu
XML
Clinical care/Education/Nutrition
Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND): study design and baseline characteristics of patients with type 2 diabetes newly initiating oral antidiabetic drug monotherapy in Japan
  1. Daisuke Yabe1,2,3,
  2. Hiroko Higashiyama4,
  3. Takashi Kadowaki5,6,
  4. Hideki Origasa7,
  5. Iichiro Shimomura8,
  6. Hirotaka Watada9,
  7. Keisuke Tobe10,
  8. Kristy Iglay11,
  9. Shigeru Tokita10,
  10. Yutaka Seino12,13
  1. 1Kansai Electric Power Medical Research Institute, Kobe, Japan
  2. 2Department of Diabetes and Endocrinology, Gifu University Graduate School of Medicine, Gifu, Japan
  3. 3Division of Molecular and Metabolic Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
  4. 4Division of Medical Education, Kansai Electric Medical Research Institute, Osaka, Japan
  5. 5Department of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
  6. 6Toranomon Hospital, Tokyo, Japan
  7. 7Department of Biostatistics and Clinical Epidemiology, The University of Toyama School of Medicine, Toyama, Japan
  8. 8Department of Metabolic Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan
  9. 9Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan
  10. 10MSD K.K, Tokyo, Japan
  11. 11Merck & Co., Inc, Kenilworth, New Jersey, USA
  12. 12Kansai Electric Power Hospital, Osaka, Japan
  13. 13Kansai Electric Power Medical Research Institute, Osaka, Japan
  1. Correspondence to Dr Yutaka Seino; seino.yutaka{at}e2.kepco.co.jp

Abstract

Introduction To investigate factors affecting glycemic control, oral antidiabetic drug (OAD) treatment distribution and self-care activities among patients with type 2 diabetes mellitus (T2DM) who newly initiate OAD monotherapy in a real-world setting in Japan.

Research design and methods A Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND) is an ongoing, prospective, observational cohort study with follow-up at 6, 12, 18 and 24 months. Primary objectives include OAD treatment patterns (cross-sectional and longitudinal) among diabetes specialists versus non-specialists; adherence to diabetes self-care activities; quality of life; treatment satisfaction among patients and target attainment rates of parameters, including glycated hemoglobin. Here, we present the study design and baseline data.

Results Of 1506 patients enrolled (June 2016–May 2017; 174 sites in Japan), 1485 were included in the baseline analysis (617 treated by specialists, 868 by non-specialists). Most patients were prescribed dipeptidyl peptidase-4 inhibitors (DPP-4Is) (specialist vs non-specialist, 54.1% vs 57.1%), then sodium-glucose cotransporter 2 inhibitors (13.9% vs 22.2%), metformin (20.3% vs 12.9%) and other OADs (<5% individually in both groups). Regardless of age, body mass index and glycated hemoglobin, DPP-4Is were the most commonly prescribed OADs by both specialists and non-specialists. About one-fifth and one-third of patients visiting specialists and non-specialists, respectively, received no advice on diet and exercise. The proportion of patients following self-care recommendations for diet and exercise (2/5 items on the Summary of Diabetes Self-Care Activities) was significantly higher among those visiting specialists than non-specialists.

Conclusion The use of newer OAD was common across a broad range of clinical characteristics in patients with T2DM who newly initiated monotherapy in Japan. However, patient-related and physician-related factors could affect the treatment changes during the following course of treatment. In addition, treatment outcome could vary with the observed difference in the level of patient education provided by diabetes specialists versus non-specialists.

  • hypoglycemic agents
  • education
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjdrc-2020-001361

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Supplementary materials

    • Supplementary Data

      This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    Footnotes

    • Contributors All authors contributed to the study design, the interpretation of the results and the critical review of the manuscript. DY, KT, KI, ST and YS were involved in the conception of the study and drafted the manuscript. DY and KT were responsible for data analysis.

    • Funding This study was funded by MSD K.K., Tokyo, Japan.

    • Competing interests DY has received personal fees from MSD during the conduct of the study. His relevant financial activities outside the submitted work are grants and personal fees from Nippon Boehringer Ingelheim and Novo Nordisk and grants from Ono, Taisho Toyama, Takeda, Terumo and Arkray. HH has received personal fees and non-financial support from MSD during the conduct of the study and grants from Novartis outside the submitted work. TK has received consulting fees from MSD for the work under consideration for publication. His relevant financial activities outside the submitted work are contract research funds from AstraZeneca and Takeda; joint research funds from Daiichi Sankyo; grants from Astellas, Daiichi Sankyo, Eli Lilly, Kissei, Mitsubishi Tanabe, MSD, Novo Nordisk, Ono, Sanofi, Sumitomo Dainippon, Taisho and Takeda and fees for consulting and/or lectures from Abbott, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Cosmic, Daiichi Sankyo, Eli Lilly, Fujifilm, Johnson & Johnson, Kissei, Kowa, Kyowa Hakko Kirin, Medical Review, Medical View, Medscape Education, Medtronic Sofamor Danek, Mitsubishi Tanabe, MSD, Musashino Foods, Nipro, Novartis, Novo Nordisk, Ono, Sanofi, Sanwa Kagaku, Sumitomo Dainippon, Taisho, Takeda and Terumo. He has also been an Endowed Chair for Asahi Mutual Life Insurance, Boehringer Ingelheim, Kowa, Mitsubishi Tanabe, MSD, Novo Nordisk, Ono and Takeda. HO has received personal fees from MSD during the conduct of the study. IS has received grants and personal fees from MSD during the conduct of the study. His relevant financial activities outside the submitted work are grants and personal fees from Astellas, AstraZeneca, Mitsubishi Tanabe, Eli Lilly, Novo Nordisk, Ono, Sanofi and Takeda; grants from Daiichi Sankyo, Kissei, Kowa, Kyowa Hakko Kirin, Mochida, Novartis, Rohto, Shionogi, Sumitomo Dainippon, Teijin and Terumo and personal fees from Kowa, Nippon Boehringer Ingelheim and Sanwa Kagaku. HW has received grants and personal fees from MSD during the conduct of the study. His relevant financial activities outside the submitted work are grants and personal fees from Astellas, Daiichi Sankyo, Eli Lilly, Mitsubishi Tanabe, Nippon Boehringer Ingelheim, Novartis, Novo Nordisk, Ono, Sanofi, Sanwa Kagaku, Sumitomo Dainippon and Takeda; grants from Johnson & Johnson, Teijin, Yakult, Kissei, Kowa, Kyowa Hakko Kirin, Pfizer and Taisho Toyama and personal fees from Fujifilm, Terumo and AstraZeneca. KI was employed by Merck & Co., Inc., Kenilworth, New Jersey, USA, during the conduct of this study and owns stock. YS has received personal fees from MSD during the conduct of the study. His relevant financial activities outside the submitted work are grants and personal fees from Novo Nordisk and Taisho Toyama; grants from Arkray Marketing, Bayer, Boehringer Ingelheim, Ono, Sumitomo Dainippon and Terumo and personal fees from Kao, Nippon Becton Dickinson, Nippon Boehringer Ingelheim, Taisho and Takeda. KT and ST are employees of MSD K.K. and own stock.

    • Patient consent for publication Not required.

    • Ethics approval This study was approved by Toukeikai Kitamachi Clinic ethical review board (Approval number MSD04820) and was conducted in compliance with the principles of the Declaration of Helsinki.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available on reasonable request. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA’s data sharing policy, including restrictions, is available at http://engagezone.msd.com/ds_documentation.php. Requests for access to the study data can be submitted through the EngageZone site or via email to dataaccess@merck.com.