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. 2025 Sep;62(9):1469-1478.
doi: 10.1007/s00592-025-02475-6. Epub 2025 Feb 27.

Long-term efficacy of daily oral semaglutide as add-on or switch therapy in adults with type 2 diabetes: a 12-month real-world retrospective study

Daniela Sansone  1 , Francesca Garino  2 , Cristina Gottero  2 , Carlotta Gauna  2 , Alessandra Clerico  2 , Ginevra Corneli  2 , Fabiana Di Noi  2 , Alessandra Rita Mainolfi  2 , Claudio Rossi  2 , Lisa Marafetti  2 , Cristina Matteoda  2 , Marcella Libera Balbo  2 , Giuliana Petraroli  2 , Nadia Bonelli  2 , Claudia Chiara M Toscano  2 , Licia Visconti  2 , Salvatore Oleandri  2
Affiliations

Long-term efficacy of daily oral semaglutide as add-on or switch therapy in adults with type 2 diabetes: a 12-month real-world retrospective study

Daniela Sansone et al. Acta Diabetol. 2025 Sep.

Abstract

Aims: To evaluate the efficacy of oral semaglutide, either as an add-on or replacement therapy, in improving glycemic control, body weight, and cardiovascular parameters in patients with type 2 diabetes mellitus (T2DM).

Methods: This real-world study evaluated changes in glycated hemoglobin (HbA1c), body weight, and parameters of cardiovascular risk from baseline to a 12-month follow-up visit. The primary endpoint was the change in HbA1c between baseline and follow-up. Secondary endpoints included changes in body weight, the proportion of patients achieving HbA1c ≤ 7%, and combined reductions in HbA1c (≥ 1%) and body weight (≥ 5%). Exploratory endpoints were evaluated as well.

Results: Data from 950 patients, predominantly female (63.7%) and with a mean age of 68.3 ± 10.1 years, were included in the study. Prior to starting semaglutide, most patients were on sulfonylureas, either as monotherapy or in combination with metformin or basal insulin. At baseline, mean HbA1c was 8.0 ± 1.3% (64.0 ± 14.2 mmol/mol), and body weight was 82.5 kg. Following 12 months of oral semaglutide treatment, HbA1c decreased significantly of -0.84% (p < 0.001) and 53% of patients achieved HbA1c ≤ 7%. HbA1c reductions were influenced by baseline levels and patient's age. Body weight decreased by 2.28 kg (p < 0.001) and 18.4% of patients achieved both ≥ 1% reduction in HbA1c and ≥ 5% in body weight. Diastolic blood pressure and LDL levels decreased significantly (p < 0.001), while systolic blood pressure and eGFR remained stable.

Conclusions: When used as an add-on or replacement therapy, oral semaglutide significantly improves glycemic control, body weight, renal and cardiovascular risk factors in T2DM patients.

Keywords: Body weight; Cardiovascular risk; GLP1-RA; HbA1c; Oral semaglutide; Real-word evidence; Type 2 diabetes mellitus.

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Conflict of interest statement

Declarations. Conflict of interest: All authors have nothing to declare. Ethical statement: The study was approved by the relevant ethics committee and adhered to the Good Clinical Practice guidelines concerning clinical investigations on human subjects and the Declaration of Helsinki. Informed consent: All participants provided written informed consent to participate in the study.

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