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

📖 Top 20% JournalMar 25, 2025Diabetes therapy : research, treatment and education of diabetes and related disorders

Daily Oral Semaglutide Use in Adults with Type 2 Diabetes in Real-Life Italy

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Abstract

A median treatment follow-up of 40 weeks resulted in an estimated change in glycated hemoglobin of -0.9%-points and a body weight reduction of -3.8 kg.

A total of 398 out of 445 eligible participants completed the study.
At the end of the study, 65.1% of participants achieved a glycated hemoglobin level of less than 7%.
25.5% and 19.1% of participants experienced a reduction in glycated hemoglobin of at least 1%-point along with at least a 3% or 5% reduction in body weight, respectively.
Treatment satisfaction, as measured by the Diabetes Treatment Satisfaction Questionnaires, improved significantly.
No new safety signals were observed throughout the study.

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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 () from baseline to the end of study (EoS). Secondary endpoints were the change in body weight (BW), the percentage of participants attaining HbA < 7%, composite endpoints of HbAreduction ≥ 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. 1c1c1c

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, HbAof 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 HbAand 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 HbA < 7%; 25.5% and 19.1% reached HbAreduction ≥ 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. 1c1c1c1c

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.

Key numbers

-0.9%-points

Reduction in

Change in from to .

-3.8 kg

Body Weight Reduction

Change in body weight from to .

65.1%

Achieved < 7%

Percentage of participants achieving < 7% at .

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Abstract

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