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Long-term comparative effectiveness of once-weekly semaglutide versus alternative treatments in a real-world US adult population with type 2 diabetes: a randomized pragmatic clinical trial

J. Buse,Helene Nordahl Christensen,Brian J Harty,M. Cziraky,Vincent J Willey,Simon Skibsted

Published 2025 in BMJ Open Diabetes Research & Care

ABSTRACT

Introduction This study evaluated the long-term effectiveness of once-weekly subcutaneous semaglutide versus alternative treatment in adults with type 2 diabetes (T2D) in routine clinical practice. Research design and methods The SEmaglutide PRAgmatic (SEPRA) was a 2-year, randomized, open-label, pragmatic clinical trial (NCT03596450). Adults with T2D and inadequate glycemic control on one or two oral antidiabetic medications were randomized to receive once-weekly subcutaneous semaglutide or alternative treatment (chosen by the treating physician) as add-on therapy. Endpoints included proportion of participants achieving glycated hemoglobin (HbA1c)<7.0% at year 1 (primary endpoint) and year 2; changes in HbA1c (percentage point), body weight, and patient-reported outcomes (PROs) at years 1 and 2; and treatment changes (baseline to year 2). Missing data were imputed for some analyses. Results Participants were randomized to semaglutide (n=644) or alternative treatment (n=634). Proportions of participants achieving HbA1c <7.0% were significantly higher with semaglutide versus alternative treatment at years 1 (53.1% vs 45.5%; OR (95% CI): 1.36 (1.03 to 1.79); p=0.033) and 2 (49.9% vs 38.9%; OR (95% CI): 1.56 (1.13 to 2.16); p=0.007). Mean HbA1c decreases were larger with semaglutide versus alternative treatment at year 1 (−1.35% vs −1.16%; estimated treatment difference (ETD) (95% CI): −0.20% (−0.39% to 0.00%); p=0.046) and year 2 (−1.27% vs −0.96%; ETD (95% CI): −0.31% (−0.57% to −0.05%); p=0.018). Semaglutide was associated with larger reductions in body weight at year 1 (−3.57% vs −1.91%; ETD (95% CI): −1.65% (−2.92% to −0.39%); p=0.010) but not year 2 (p=0.175). Treatment changes occurred less frequently with semaglutide than with alternative treatments. Some PROs indicated greater improvement with semaglutide versus alternative treatment. No new safety concerns were identified. Conclusions SEPRA demonstrates that semaglutide is an appropriate choice for treatment intensification among individuals with T2D in the USA who are receiving 1–2 antidiabetic medications. Findings support semaglutide as an effective and well-tolerated option in clinical practice. Trial registration number NCT03596450.

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