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Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin.

N Engl J Med

July 2023

From Velocity Clinical Research at Medical City (J.R.) and the Division of Endocrinology, Department of Internal Medicine, and the Peter O'Donnell Jr. School of Public Health, University of Texas Southwestern Medical Center (I.L.) - both in Dallas; Swansea University Medical School, Swansea, United Kingdom (S.C.B.); Novo Nordisk, Søborg, Denmark (A.G., B.L.); Servicio de Endocrinología y Nutrición, Hospital Universitario Quironsalud Madrid, Facultad de Medicina, Universidad Europea, Madrid (E.J.); Novo Nordisk, Tokyo (T.N.); Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo (R.T.), and the Department of Medicine and Surgery, University of Milano Bicocca, Milan (R.T.) - both in Italy; and the Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center (O.M.), and the Faculty of Medicine, Hebrew University of Jerusalem (O.M.) - both in Jerusalem.

Background: Insulin icodec is an investigational once-weekly basal insulin analogue for diabetes management.

Methods: We conducted a 78-week randomized, open-label, treat-to-target phase 3a trial (including a 52-week main phase and a 26-week extension phase, plus a 5-week follow-up period) involving adults with type 2 diabetes (glycated hemoglobin level, 7 to 11%) who had not previously received insulin. Participants were randomly assigned in a 1:1 ratio to receive once-weekly insulin icodec or once-daily insulin glargine U100.

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