Impact of baseline characteristics and beta-cell function on the efficacy and safety of subcutaneous once-weekly semaglutide: A patient-level, pooled analysis of the SUSTAIN 1-5 trials.

ABSTRACT: AIM:To evaluate the impact of relevant patient-level characteristics on the efficacy and safety of subcutaneous, once-weekly semaglutide in subjects with type 2 diabetes. MATERIALS AND METHODS:Exploratory post hoc analyses of pooled SUSTAIN 1-5 (phase 3a) randomized, controlled trials examined the change from baseline in HbA1c and body weight (BW), and the proportions of subjects achieving the composite endpoint (HbA1c 7.5%-8.0%, >8.0%-8.5%, >8.5%-9.0% and?>?9.0%), background medications, diabetes duration and pancreatic beta-cell function. RESULTS:Mean HbA1c (% point) reductions increased from lowest to highest HbA1c subgroups (-0.9%, -1.2%,-1.5%, -1.7% and -2.3% [effect of subgroup within treatment: P =?0.247] for semaglutide 0.5?mg, and -1.1%, -1.4%, -1.9%, -2.1% and -2.7% [P =?0.045] for semaglutide 1.0?mg), with mean HbA1c ranges at week 30 of 6.3%-7.3% and 6.1%-6.9%, respectively. The corresponding BW reductions generally decreased with increasing baseline HbA1c (-4.4, -3.9, -3.9, -3.3 and -2.9?kg [P =?0.004], and -6.4, -5.9, -5.2, -4.5 and -4.8?kg [P

SUBMITTER: Aroda VR 

PROVIDER: S-EPMC7065219 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature