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Multicenter Study
. 2024 Aug;15(8):1047-1056.
doi: 10.1111/jdi.14219. Epub 2024 May 6.

PIONEER REAL Japan: Baseline characteristics of a multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in clinical practice in Japan

Ryo Suzuki  1 , Hanan Amadid  2 , Atheline Major-Pedersen  3 , Daisuke Yabe  4   5   6
Affiliations
Multicenter Study

PIONEER REAL Japan: Baseline characteristics of a multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in clinical practice in Japan

Ryo Suzuki et al. J Diabetes Investig. 2024 Aug.

Abstract

Aims/introduction: PIONEER REAL Japan was a non-interventional, multicenter, prospective study investigating oral semaglutide in adults with type 2 diabetes in routine clinical practice. We report baseline characteristics of participants enrolled in this study.

Materials and methods: Adults aged ≥20 years with type 2 diabetes but no previous treatment with injectable glucose-lowering medication were enrolled. Participants initiated oral semaglutide at their treating physician's discretion and were followed for 34-44 weeks. Participants were stratified into <75-year-old and ≥75-year-old subgroups.

Results: A total of 624 participants initiated the study. The mean (standard deviation) age was 64.1 years (14.1), the mean (standard deviation) body weight was 72.4 kg (16.1), and the mean (standard deviation) body mass index was 27.5 kg/m2 (5.0). Participants had a median (interquartile range) type 2 diabetes duration of 9.3 years (4.2, 15.2) and mean (standard deviation) glycated hemoglobin 7.7% (1.1). Most (75.6%) participants were taking glucose-lowering medications at baseline; the most common was metformin (51.9%). The main reasons for initiating oral semaglutide were glycemic control and weight loss. Most (86.0%) participants had an individualized target for glycemic control of glycated hemoglobin ≤7%. The <75-year-old subgroup was heavier (mean [standard deviation] body mass index 28.6 kg/m2 [5.2] vs 25.1 kg/m2 [3.4]) but had comparable glycated hemoglobin levels (mean [standard deviation] 7.7% [1.2] vs 7.8% [1.0]) to the ≥75-year-old subgroup.

Conclusions: PIONEER REAL Japan describes the characteristics of individuals with type 2 diabetes prescribed oral semaglutide. The baseline characteristics provide insights into Japanese individuals with type 2 diabetes prescribed oral semaglutide in clinical practice.

Keywords: Prospective studies; Semaglutide; Type 2 diabetes.

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Conflict of interest statement

RS received lecture fees from Novo Nordisk. HA and AM‐P report employment with, and being shareholders in, Novo Nordisk. DY received consulting/lecture fees from Novo Nordisk Pharma Ltd, Nippon Boehringer Ingelheim, Eli Lilly Japan K.K., and Kyowa Kirin Co. Ltd; and grants from Arkray Inc., Novo Nordisk Pharma Ltd, Nippon Boehringer Ingelheim, Taisho Pharmaceutical Co. Ltd, and Terumo Corporation. DY is an Editorial Board member of the Journal of Diabetes Investigation and a co‐author of this article. To minimize bias, they were excluded from all editorial decision‐making related to the acceptance of this article for publication.

Approval of the research protocol: The protocol for this research project has been approved by suitably constituted Ethics Committees or Institutional Review Boards of the institutions and it conforms to the provisions of the Declaration of Helsinki. Ethics Committees, Institutional Review Boards and approval numbers are listed in the Supporting Information.

Informed consent: All informed consent was obtained from the participants and/or guardians.

Registration no. of the study/trial: This study is registered with ClinicalTrials.gov (NCT04878393; first submitted May 5, 2021).

Animal studies: Not applicable.

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