230-OR: Comparative Effectiveness of Semaglutide in Type 2 Diabetes—Year 2 Results of a Randomized Pragmatic Clinical Trial

The objective of this study was to generate real-world evidence to support clinical decision-making by evaluating the long-term effects of once-weekly SC semaglutide (sema) in routine clinical practice. SEPRA was a 2-year open-label, randomized, pragmatic study (NCT03596450) comparing the effectiveness of sema vs physician’s choice standard of care (SOC; any antidiabetes drug excluding sema) when added to ≤2 OADs for treatment intensification in adults with T2D. Endpoints at 2 years included percentage of patients achieving HbA1c 7%, %-point change in HbA1c from baseline, and change in body weight. Patients were randomized to receive sema (n=644) or SOC (n=634); 58% and 59% had recorded HbA1c levels at year 2, respectively. Baseline characteristics were comparable between groups (Table). Sema dosing at year 2 was 17.5% at 0.25 mg, 22.7% at 0.5 mg, and 27.5% at 1 mg (22.8% left the study, 8.9% were not on sema). Of patients receiving SOC at year 2, 37.4% were not receiving the treatment selected for intensification. At year 2, a significantly greater percentage of patients achieved HbA1c 7% and numerically greater weight loss with sema vs SOC. A lower percentage of patients required further treatment intensification with sema vs SOC. No new safety concerns were identified. SEPRA demonstrated that sema is more effective and durable than SOC for T2D treatment intensification in routine clinical practice. Disclosure J.B. Buse: Other Relationship; Novo Nordisk. Consultant; Corcept Therapeutics. Research Support; Corcept Therapeutics, Dexcom, Inc., Insulet Corporation. Consultant; Alkahest, Anji Pharmaceuticals, Aqua Medical, Altimmune Inc., AstraZeneca, Boehringer-Ingelheim, CeQur, Eli Lilly and Company, embecta, GentiBio, Glyscend Inc., Mellitus Health, Metsera, Pendulum Therapeutics, Praetego, LLC, Stability Health, Terns Pharmaceuticals, Insulet Corporation, Vertex Pharmaceuticals Incorporated, vTv Therapeutics. Other Relationship; Medtronic. Stock/Shareholder; Glyscend Inc., Mellitus Health, Pendulum Therapeutics, Praetego, LLC, Stability Health. B.P. Soule: Employee; Novo Nordisk. B.J. Harty: Research Support; Novo Nordisk. H. Nordahl: Employee; Novo Nordisk. M.J. Cziraky: Other Relationship; Carelon Research. V. Willey: Other Relationship; Carelon Research. S. Skibsted: Employee; Novo Nordisk A/S. Funding Novo Nordisk Inc.