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Introduction <p>The PIONEER REAL Italy study examined the clinical outcomes associated with oral semaglutide in real-world settings.</p> Methods <p>This was a multicenter, prospective, non-interventional, single-arm study in adults with type 2 diabetes (T2D) who were treatment-naive to injectable glucose-lowering medications. Participants initiated oral semaglutide at doses of 3, 7, or 14&#xa0;mg, and were followed for 34–44&#xa0;weeks. The primary endpoint was the change in glycated hemoglobin (HbA<sub>1c</sub>) from baseline to the end of study (EoS). Secondary endpoints were the change in body weight (BW), the percentage of participants attaining HbA<sub>1c</sub> &lt; 7%, composite endpoints of HbA<sub>1c</sub> reduction ≥ 1%-point plus BW reduction (≥ 3%/ ≥ 5%), and treatment satisfaction measured using Diabetes Treatment Satisfaction Questionnaires (DTSQ) status. Safety was assessed in participants who received ≥ 1 dose of oral semaglutide.</p> Results <p>Of 445 eligible participants, 398 completed the study; 351 (78.9%) remained on oral semaglutide at EoS. The median time of treatment follow-up was 40&#xa0;weeks for each participant. At baseline, participants had a mean (standard deviation [SD]) age of 62.9 (10.2) years, HbA<sub>1c</sub> of 7.8% (1.3), T2D duration of 8.0 (6.9) years, and BW of 87.8 (19.0) kg. The estimated changes (95% confidence interval) from baseline to EoS in HbA<sub>1c</sub> and BW were −&#xa0;0.9%-points (−&#xa0;1.01 to −&#xa0;0.82;<i> p</i> &lt; 0.0001) and −&#xa0;3.8&#xa0;kg (−&#xa0;4.45 to −&#xa0;3.24; <i>p</i> &lt; 0.0001), respectively. At EoS, 65.1% achieved HbA<sub>1c</sub> &lt; 7%; 25.5% and 19.1% reached HbA<sub>1c</sub> reduction ≥ 1%-point plus ≥ 3% and ≥ 5% reduction in BW, respectively. DTSQ status improved significantly at EoS (estimated change + 5.24; 95% CI, 5.24 to 6.61, <i>p</i> &lt; 0.0001). Of participants who remained on oral semaglutide at EoS, 72.6% received a 7-mg dose. No new safety signals were observed.</p> Conclusions <p>In Italy, the real-world clinical outcomes associated with oral semaglutide in adults with T2D complemented the findings from clinical trials. This reassures oral semaglutide usage in routine clinical practice.</p> Trial Registration <p>NCT05230615.</p>

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PIONEER REAL Italy: Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月25日

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  • Roberta Manti,
  • Salvatore De Cosmo,
  • Paolo Desenzani,
  • Lidia Ferrara,
  • Angela Girelli,
  • Giuseppe Memoli,
  • Alessandro Bisio,
  • Uffe Christian Braae,
  • Alisa Deinega,
  • Cesare Berra,
  • Massimiliano Anzaldi,
  • Maria Cassone Faldetta,
  • Pasquale De Cata,
  • Chiara Di Loreto,
  • Marco Gallo,
  • Daniela Gioia,
  • Carla Giordano,
  • Francesco Manetti,
  • Alberto Marangoni,
  • Pasqualina Memoli,
  • Marco Mirani,
  • Agostino Paccagnella,
  • Alessia Scatena,
  • Rosalia Serra,
  • Marco Strazzabosco,
  • Claudio Ventura

摘要

Introduction

The PIONEER REAL Italy study examined the clinical outcomes associated with oral semaglutide in real-world settings.

Methods

This was a multicenter, prospective, non-interventional, single-arm study in adults with type 2 diabetes (T2D) who were treatment-naive to injectable glucose-lowering medications. Participants initiated oral semaglutide at doses of 3, 7, or 14 mg, and were followed for 34–44 weeks. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline to the end of study (EoS). Secondary endpoints were the change in body weight (BW), the percentage of participants attaining HbA1c < 7%, composite endpoints of HbA1c reduction ≥ 1%-point plus BW reduction (≥ 3%/ ≥ 5%), and treatment satisfaction measured using Diabetes Treatment Satisfaction Questionnaires (DTSQ) status. Safety was assessed in participants who received ≥ 1 dose of oral semaglutide.

Results

Of 445 eligible participants, 398 completed the study; 351 (78.9%) remained on oral semaglutide at EoS. The median time of treatment follow-up was 40 weeks for each participant. At baseline, participants had a mean (standard deviation [SD]) age of 62.9 (10.2) years, HbA1c of 7.8% (1.3), T2D duration of 8.0 (6.9) years, and BW of 87.8 (19.0) kg. The estimated changes (95% confidence interval) from baseline to EoS in HbA1c and BW were − 0.9%-points (− 1.01 to − 0.82; p < 0.0001) and − 3.8 kg (− 4.45 to − 3.24; p < 0.0001), respectively. At EoS, 65.1% achieved HbA1c < 7%; 25.5% and 19.1% reached HbA1c reduction ≥ 1%-point plus ≥ 3% and ≥ 5% reduction in BW, respectively. DTSQ status improved significantly at EoS (estimated change + 5.24; 95% CI, 5.24 to 6.61, p < 0.0001). Of participants who remained on oral semaglutide at EoS, 72.6% received a 7-mg dose. No new safety signals were observed.

Conclusions

In Italy, the real-world clinical outcomes associated with oral semaglutide in adults with T2D complemented the findings from clinical trials. This reassures oral semaglutide usage in routine clinical practice.

Trial Registration

NCT05230615.