776-P: Comparative Effectiveness of SC Semaglutide in Adults with T2D in U.S. Routine Clinical Practice—Year 1 Results of SEPRA, a Randomized Pragmatic Clinical Trial

Abstract

SEPRA, a 2-year, ongoing, open-label, randomized, pragmatic study (NCT03596450) compares the effects of once-weekly SC semaglutide (sema) with physician's choice SOC when added to ≤2 oral antidiabetic medications for treatment intensification in US health-insured adults with T2D. The objective is to generate real-world evidence to support routine clinical decision making and complement clinical trial data. The primary endpoint is the proportion of patients who achieve HbA1c <7% at 1 year. Patients (N=1278) were randomized to receive sema according to label (n=644) or SOC excluding sema (n=634). All other treatment was per routine clinical care. Baseline characteristics were comparable (Table 1). Most common SOC medications were other GLP-1RAs (71.3%) and SGLT2is (15.5%). Sema dosing at 1 year was 26.6% at 0.25 mg, 30.4% at 0.5 mg and 24.4% at 1 mg (10.6% ended study and 7.6% not on sema at year 1). Use of sema resulted in a significantly greater proportion of patients achieving HbA1c <7% and body weight reduction vs SOC at 1 year (Table 1). A lower proportion of sema patients required additional treatment intensification in year 1 of the study vs SOC. No new safety concerns were identified. SEPRA demonstrates the superior effect of sema vs physician's choice SOC and that sema is an efficacious, durable treatment option in routine clinical practice. Disclosure J.B.Buse: Consultant; Alkahest, Anji Pharmaceuticals, AstraZeneca, Bayer Inc., Biomea Fusion, Inc., Boehringer Ingelheim International GmbH, CeQur SA, Cirius Therapeutics, Inc., Corcept Therapeutics, Eli Lilly and Company, GentiBio, Glycadia, Glyscend Inc., Janssen Pharmaceuticals, Inc., Mellitus Health, Pendulum Therapeutics, Praetego, LLC, Stability Health, Terns, Inc, Valo, Other Relationship; Novo Nordisk, Research Support; Dexcom, Inc., Novo Nordisk, vTv Therapeutics, Stock/Shareholder; Glyscend Inc., Mellitus Health, Pendulum Therapeutics, PhaseBio Pharmaceuticals, Inc., Praetego, LLC, Stability Health. B.P.Soule: Employee; Novo Nordisk. B.J.Harty: Research Support; Novo Nordisk. H.N.Christensen: Employee; Novo Nordisk, Stock/Shareholder; Novo Nordisk A/S. M.J.Cziraky: Other Relationship; Novo Nordisk. V.Willey: Other Relationship; Novo Nordisk A/S. S.Skibsted: Employee; Novo Nordisk A/S. Funding Novo Nordisk