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; Hanan Amadid; Atheline Major-Pedersen; Daisuke Yabe

doi:10.1111/jdi.14219

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

J Diabetes Investig. 2024 May 6. doi: 10.1111/jdi.14219. Online ahead of print.

Authors

Ryo Suzuki¹, Hanan Amadid², Atheline Major-Pedersen³, Daisuke Yabe^{4

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Affiliations

¹ Department of Diabetes, Metabolism, and Endocrinology, Tokyo Medical University, Tokyo, Japan.
² Global Clinical Drug Development, Novo Nordisk A/S, Søborg, Denmark.
³ Global Safety, Novo Nordisk A/S, Søborg, Denmark.
⁴ Department of Diabetes, Endocrinology, and Metabolism and Department of Rheumatology and Clinical Immunology, Gifu University Graduate School of Medicine, Gifu, Japan.
⁵ Center for One Medicine Innovative Translational Research, Gifu University, Gifu, Japan.
⁶ Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kyoto, Japan.

PMID: 38711208
DOI: 10.1111/jdi.14219

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.

Grants and funding

Novo Nordisk