Visual Abstract
Once-weekly (OW) semaglutide is a glucagon-like peptide-1 analog approved for the treatment of type 2 diabetes. Across the SUSTAIN clinical trials, semaglutide led to superior HbA1c and body weight (BW) reductions vs. comparators. These benefits need to be balanced against the risk of hypoglycemia and gastrointestinal adverse events (GI AEs). We conducted a post hoc analysis of the SUSTAIN 7-10 trials to evaluate composite endpoints of HbA1c, BW, hypoglycemia +/- moderate/severe GI AEs.
For each trial, logistic regression was used to assess those achieving each of two composite endpoints at end of treatment: HbA1c <7%, no weight gain and no severe or blood-glucose-confirmed symptomatic hypoglycemia (prespecified ‘triple endpoint’) and the triple endpoint plus no moderate/severe GI AEs (post hoc ‘quadruple endpoint’).
Significantly greater proportions of subjects treated with semaglutide achieved the triple (p≤0.0001) and quadruple (p<0.05) endpoints vs. comparators in all trials (Table).
In SUSTAIN 7-10, OW semaglutide was superior to comparators in achieving HbA1c <7% without weight gain or hypoglycemia. Superiority was maintained for semaglutide when moderate/severe GI AEs were included in this prespecified endpoint.
K. Khunti: Advisory Panel; Self; Amgen Inc., AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Berlin-Chemie AG, Lilly Diabetes, Merck Sharp & Dohme Corp., Napp Pharmaceuticals, Novo Nordisk, Roche Pharma, Sanofi-Aventis. C. Hindsberger: Consultant; Self; Novo Nordisk A/S, Stock/Shareholder; Self; Novo Nordisk A/S, Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. J. Lawson: Employee; Self; Novo Nordisk A/S. B. Vrhnjak: Employee; Self; Novo Nordisk A/S. C. Le roux: Advisory Panel; Self; Boehringer Ingelheim International GmbH, GI Dynamics, Herbalife International of America, Inc., Johnson & Johnson, Medtronic, Novo Nordisk A/S.
Novo Nordisk A/S
