Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies

📖 Top 20% JournalNov 13, 2024Diabetes therapy : research, treatment and education of diabetes and related disorders

Oral Semaglutide use in type 2 diabetes: combined clinical and patient-reported results from seven real-world studies

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Abstract

Oral semaglutide treatment resulted in an estimated 1.0%-point reduction in (HbA) and a 5.0% decrease in body weight by week 38.

A total of 1615 participants initiated oral semaglutide treatment, with 1222 (76%) remaining on treatment by the end of the study.
Significant improvements in treatment satisfaction were reported throughout the study duration.
Younger individuals with shorter type 2 diabetes duration experienced greater reductions in HbA and body weight.
Higher baseline HbA levels were associated with more significant decreases in HbA during treatment.
No significant differences in clinical outcomes were observed based on age or whether care was provided in a specialist or primary care setting.

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INTRODUCTION: Oral semaglutide is a (GLP-1RA) approved for improving glycemic control in adults with type 2 diabetes (T2D). The PIONEER REAL program evaluates clinical and patient-reported outcomes of oral semaglutide treatment as part of routine clinical practice across 13 countries. Here, data from Canada, Denmark, Italy, the Netherlands, Sweden, Switzerland, and the UK are pooled and analyzed to address treatment satisfaction as well as (HbA) and body weight changes in relevant subgroup analyses. 1C

METHODS: This pooled analysis encompasses seven country-specific, non-interventional, multicenter, phase 4, prospective, single-arm clinical studies assessing the use of oral semaglutide in adults with T2D. Primary endpoint was the change in HbAfrom baseline to end of study (EOS), and secondary endpoints included changes in body weight and treatment satisfaction. For the analyses, results were stratified by age, T2D duration, and oral semaglutide dose at EOS as well as baseline HbA, body weight, and body mass index. 1C1C

RESULTS: Oral semaglutide treatment was initiated by 1615 participants. At EOS, 1222 (76%) participants out of the 1483 (92%) who completed the study were on treatment. Estimated changes in HbAand body weight from baseline to week 38 were - 1.0%-point (95% CI - 1.08 to - 0.97; P < 0.0001) and - 5.0% (CI - 5.37 to - 4.72; P < 0.0001). Treatment satisfaction increased significantly during the study. Shorter T2D duration interacted with higher HbAreduction and body weight loss. Interaction was also observed between higher baseline HbAand more pronounced decrease in HbA. No significant interactions were detected between clinical outcomes and age or physician setting. 1C1C1C1C

CONCLUSION: The PIONEER REAL pooled analysis shows that people initiating oral semaglutide treatment experience improved glycemic control and body weight loss across age groups and T2D duration. This occurs regardless of specialist or primary care practice setting and is accompanied by an increased treatment satisfaction.

CLINICAL TRIAL REGISTRATIONS: NCT04559815 (Canada), NCT04537637 (Denmark), NCT05230615 (Italy), NCT04601740 (the Netherlands), NCT04601753 (Sweden), NCT04537624 (Switzerland), NCT04862923 (UK).

Key numbers

-1.0%-point

Reduction

Change in from to week 38

-5.0%

Body Weight Reduction

Change in body weight from to week 38

3.5 points

Treatment Satisfaction Increase

Increase in treatment satisfaction score at

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Abstract

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