Study design and baseline profile for adults with type 2 diabetes in the once-weekly subcutaneous SEmaglutide randomized PRAgmatic (SEPRA) trial

Autor: Julie Mitchell, John B Buse, Mark Cziraky, Helene Nordahl Christensen, Brian J Harty, Benjamin P Soule, Emily Zacherle, Vincent J Willey
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: BMJ Open Diabetes Research & Care, Vol 11, Iss 3 (2023)
Druh dokumentu: article
ISSN: 2052-4897
DOI: 10.1136/bmjdrc-2022-003206
Popis: Introduction Once-weekly subcutaneous semaglutide, a glucagon-like peptide-1 analog, is approved in the USA as an adjunct to diet and exercise for adults with inadequately controlled type 2 diabetes (T2D) to improve glycemic control and reduce the risk of major adverse cardiovascular events in people with T2D and established cardiovascular disease. The Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) phase III clinical trial program demonstrated the efficacy and safety of once-weekly subcutaneous semaglutide; however, determining its effectiveness in a real-world setting could support decision-making by clinicians, payers and policy makers in routine clinical practice.Research design and methods SEmaglutide PRAgmatic (SEPRA) is an ongoing open-label, randomized, pragmatic clinical trial designed to compare the effects of once-weekly subcutaneous semaglutide versus standard of care in US health-insured adults with T2D and physician-determined inadequate glycemic control. The primary end point is the proportion of participants achieving glycated hemoglobin (HbA1c)
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