The PIONEER trial protocols were approved by institutional review boards or independent ethics committees at the participating trial sites, and the studies were conducted in accordance with ICH Good Clinical Practice guidelines and the Declaration of Helsinki
These findings have led to the approval of semaglutide for the treatment of obesity and type 2 diabetes by regulatory bodies, such as the U.S
Diabetes Care 33(2):428433 Eguchi Y, Kitajima Y, Hyogo H, Takahashi H, Kojima M, Ono M et al (2015) Pilot study of liraglutide effects in non-alcoholic steatohepatitis and non-alcoholic fatty liver disease with glucose intolerance in Japanese patients (LEAN-J)
En ensayo clnico SURMOUNT-1, pacientes perdieron promedio de 16-23% de peso corporal
Safety data were analysed descriptively by treatment group (oral semaglutide 3 mg, 7 mg, 14 mg, flexibly dosed, and comparators) and background medication/insulin regimen subgroup for all patients in the trials for the incidence of adverse events (AEs), including serious AEs, gastrointestinal AEs and genitourinary AEs, as well as events leading to trial product discontinuation and hypoglycaemic episodes
Cancer-associated fibroblasts in colorectal cancer