Real-World Use of Oral Semaglutide in Adults with Type 2 Diabetes in the PIONEER REAL Netherlands Multicentre, Prospective, Observational Study

Jun 11, 2024Diabetes therapy : research, treatment and education of diabetes and related disorders

Use of Oral Semaglutide in Adults with Type 2 Diabetes in Real-Life Settings in the Netherlands

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Abstract

Oral semaglutide use resulted in a significant 1.16%-point reduction in HbA1c over 34-44 weeks in adults with type 2 diabetes.

A total of 187 participants initiated treatment, with 94.1% completing the study and 78.6% remaining on treatment at the end of the study.
The mean baseline HbA1c was 8.6%, while the mean body weight was 103.1 kg.
At the end of the study, 47.5% of participants achieved an HbA1c level below 7.0%.
Significant weight loss was observed, with an average reduction of -5.84 kg.
Treatment satisfaction improved, with a change score increase of 10.8 points on the Diabetes Treatment Satisfaction Questionnaire.
Most adverse events were mild or moderate, primarily involving gastrointestinal disorders.

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INTRODUCTION: In this phase 4, multicentre, prospective, non-interventional PIONEER REAL Netherlands study, we assessed clinical outcomes associated with once-daily oral semaglutide use in real-world clinical practice in adults living with type 2 diabetes (T2D) naïve to injectable glucose-lowering medication.

METHODS: Participants initiated on oral semaglutide were followed for 34-44 weeks. Change in glycated haemoglobin (HbA1c) from baseline (BL) to end of study (EOS) was the primary endpoint; secondary endpoints included change in body weight (BW) from BL to EOS, the proportion of participants with HbA1c < 7.0% at EOS and the composite endpoints of HbA1c reduction ≥ 1.0%-points with BW reduction ≥ 3% or ≥ 5% at EOS. Treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ status/change). Safety was evaluated in all participants who initiated oral semaglutide treatment.

RESULTS: Oral semaglutide was initiated in 187 participants; 94.1% completed the study and 78.6% remained on treatment at EOS. At BL, 54.0% of participants were male, mean age was 58.8 years, mean duration of T2D was 8.7 years and mean body mass index was 35.1 kg/m; mean HbA1c was 8.6% and mean BW was 103.1 kg. Significant improvements from BL to EOS were observed for HbA1c and BW (estimated change [95% confidence interval]: - 1.16%-points [- 1.48 to - 0.85]; p < 0.0001, and - 5.84 kg [- 6.88 to - 4.80]; p < 0.0001, respectively). At EOS, 47.5% of participants had an HbA1c level < 7.0%; 41.8% and 35.5% of participants achieved composite endpoints of HbA1c reduction ≥ 1.0%-points plus BW reduction ≥ 3% or ≥ 5%, respectively. DTSQ status and change scores improved by 2.1 (p = 0.0003) and 10.8 points (p < 0.0001), respectively. Oral semaglutide was easy or very easy to consume for 81.5% of participants. Adverse events were mostly mild/moderate, with gastrointestinal disorders being the most common. 2

CONCLUSION: In this real-world population, we reported clinically significant reductions in HbA1c and BW, improved treatment satisfaction and no new safety concerns. A graphical abstract is available with this article.

CLINICAL TRIAL REGISTRATION: NCT04601740.

Key numbers

1.16%-points

HbA1c Reduction

Change in HbA1c from baseline to end of study

5.84 kg

Body Weight Reduction

Change in body weight from baseline to end of study

10.8 points

Treatment Satisfaction Score Improvement

Change in Diabetes Treatment Satisfaction Questionnaire score

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Real-World Use of Oral Semaglutide in Adults with Type 2 Diabetes in the PIONEER REAL Netherlands Multicentre, Prospective, Observational Study

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