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Introduction <p>Once-weekly semaglutide has proven to be a safe and effective treatment for type 2 diabetes; however, clinical trial data on Asian populations are limited, warranting real-world data (RWD). In this study we assessed the effectiveness and safety of semaglutide in Japanese patients with type 2 diabetes using RWD.</p> Methods <p>A retrospective analysis was conducted at five diabetes centers in Japan between December 2019 and June 2022. Changes in hemoglobin A1C (HbA1c), body weight (BW), lipid parameters, liver/kidney function, and adverse events were assessed over 52&#xa0;weeks. Subgroup analyses were stratified by glucagon-like peptide-1 receptor agonist (GLP-1RA)-naïve users versus prior GLP-1RA users (GLP-1RA switch group), baseline body mass index (BMI) (&lt; 30 or ≥ 30&#xa0;kg/m<sup>2</sup>), and alanine aminotransferase (ALT) level (≤ 30 or &gt; 30 U/L).</p> Results <p>Of the 503 patients included in the study, 270 (mean age 53&#xa0;years; 61.8% men; mean duration of diabetes 10.7&#xa0;years) were included in the per-protocol analysis. Mean (± standard deviation) baseline HbA1c and BMI were 8.1 ± 1.5% and 31.7 ± 6.2&#xa0;kg/m<sup>2</sup>, respectively; 52% patients were prior GLP-1RA users. HbA1c level had fallen by approximately 0.9% at both 26 and 52&#xa0;weeks after treatment initiation (<i>p</i> &lt; 0.001), with BW reductions of − 3.2&#xa0;kg at 26&#xa0;weeks and − 4.3&#xa0;kg at 52&#xa0;weeks (<i>p</i> &lt; 0.001). Lipid profiles and liver function improved significantly (<i>p</i> &lt; 0.001). Compared to prior GLP-1RA users, GLP-1RA–naïve patients showed greater reductions in HbA1c level (− 1.2% vs. − 0.8%, <i>p</i> = 0.009) and BMI (− 1.6 vs. − 1.2&#xa0;kg/m<sup>2</sup>, <i>p</i> = 0.03). Patients with BMI ≥ 30&#xa0;kg/m<sup>2</sup> had a larger reduction in BMI than those with BMI &lt; 30 &#xa0;kg/m<sup>2</sup> (− 1.7 vs. − 1.1&#xa0;kg/m<sup>2</sup>, <i>p</i> = 0.002), and those with ALT &gt; 30 U/L showed greater HbA1c reduction (− 1.2% vs. − 0.8%, <i>p</i> = 0.04) and improved liver function than those with ALT ≤ 30 U/L. Gastrointestinal adverse events occurred in 53.7% of patients, leading to discontinuation of treatment in 7.6%.</p> Conclusions <p>Once-weekly semaglutide improved glycemic control, BW, lipid profiles, and liver function in Japanese patients with type 2 diabetes in RWD and subgroup analyses, supporting a broad effectiveness range. The rate of gastrointestinal adverse events in the RWD was comparable to that in prospective clinical studies.</p> Registration <p>University hospital Medical Information Network Clinical Trial Registry No.: UMIN000050499).</p>

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Effectiveness and Safety of Once-Weekly Semaglutide in Japanese Patients with Type 2 Diabetes: A Retrospective Observational Multicenter Study (ORIGAMI Study)

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  • 发表日期：

    2025年11月18日

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  • Yoko Iwata,
  • Fukumi Yoshikawa,
  • Manabu Saito,
  • Ayako Fuchigami,
  • Genki Sato,
  • Atsuhito Saiki,
  • Takamasa Ichijyo,
  • Nobuyuki Sato,
  • Tadamasa Ohashi,
  • Takahisa Hirose,
  • Hiroshi Uchino

摘要

Introduction

Once-weekly semaglutide has proven to be a safe and effective treatment for type 2 diabetes; however, clinical trial data on Asian populations are limited, warranting real-world data (RWD). In this study we assessed the effectiveness and safety of semaglutide in Japanese patients with type 2 diabetes using RWD.

Methods

A retrospective analysis was conducted at five diabetes centers in Japan between December 2019 and June 2022. Changes in hemoglobin A1C (HbA1c), body weight (BW), lipid parameters, liver/kidney function, and adverse events were assessed over 52 weeks. Subgroup analyses were stratified by glucagon-like peptide-1 receptor agonist (GLP-1RA)-naïve users versus prior GLP-1RA users (GLP-1RA switch group), baseline body mass index (BMI) (< 30 or ≥ 30 kg/m2), and alanine aminotransferase (ALT) level (≤ 30 or > 30 U/L).

Results

Of the 503 patients included in the study, 270 (mean age 53 years; 61.8% men; mean duration of diabetes 10.7 years) were included in the per-protocol analysis. Mean (± standard deviation) baseline HbA1c and BMI were 8.1 ± 1.5% and 31.7 ± 6.2 kg/m2, respectively; 52% patients were prior GLP-1RA users. HbA1c level had fallen by approximately 0.9% at both 26 and 52 weeks after treatment initiation (p < 0.001), with BW reductions of − 3.2 kg at 26 weeks and − 4.3 kg at 52 weeks (p < 0.001). Lipid profiles and liver function improved significantly (p < 0.001). Compared to prior GLP-1RA users, GLP-1RA–naïve patients showed greater reductions in HbA1c level (− 1.2% vs. − 0.8%, p = 0.009) and BMI (− 1.6 vs. − 1.2 kg/m2, p = 0.03). Patients with BMI ≥ 30 kg/m2 had a larger reduction in BMI than those with BMI < 30  kg/m2 (− 1.7 vs. − 1.1 kg/m2, p = 0.002), and those with ALT > 30 U/L showed greater HbA1c reduction (− 1.2% vs. − 0.8%, p = 0.04) and improved liver function than those with ALT ≤ 30 U/L. Gastrointestinal adverse events occurred in 53.7% of patients, leading to discontinuation of treatment in 7.6%.

Conclusions

Once-weekly semaglutide improved glycemic control, BW, lipid profiles, and liver function in Japanese patients with type 2 diabetes in RWD and subgroup analyses, supporting a broad effectiveness range. The rate of gastrointestinal adverse events in the RWD was comparable to that in prospective clinical studies.

Registration

University hospital Medical Information Network Clinical Trial Registry No.: UMIN000050499).