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Efficacy and safety of semaglutide for type 2 diabetes by race and ethnicity: a post hoc analysis of the SUSTAIN trials

Citation

Desouza, Cyrus et al. (2019), Efficacy and safety of semaglutide for type 2 diabetes by race and ethnicity: a post hoc analysis of the SUSTAIN trials, Dryad, Dataset, https://doi.org/10.5061/dryad.34tmpg4fv

Abstract

Context: Variations in the prevalence and aetiology of type 2 diabetes (T2D) across race and ethnicity may affect treatment responses. Semaglutide is a glucagon-like peptide-1 (GLP-1) analog approved for once–weekly, subcutaneous (s.c.) treatment of T2D.

Objective: To compare semaglutide efficacy and safety in race and ethnicity subgroups across the SUSTAIN trials.

Design: Post hoc analysis of data from phase 3 randomized SUSTAIN 1–5 and 7 (pooled) and SUSTAIN 6 trials.

Participants: 3,074 subjects (SUSTAIN 1–5 and 7); 1,648 subjects (SUSTAIN 6).

Interventions: Semaglutide 0.5 or 1.0 mg, placebo or active comparator (sitagliptin 100 mg, exenatide extended release 2.0 mg, insulin glargine 100IU/ml and dulaglutide 0.75 or 1.5 mg).

Main Outcome Measures: Change in HbA1c and body weight from baseline to week 30/40/104, other efficacy and safety endpoints.

Results: HbA1c was reduced from baseline by 1.0–1.5%-points and 1.3–2.0%-points, and body weight by 2.3–4.7 kg and 3.6–6.1 kg with semaglutide 0.5 and 1.0 mg, respectively, across race and ethnicity subgroups. Minor changes in blood pressure and lipid profiles were observed. Adverse events (AEs) were reported in similar proportions of subjects across trials. More Asian vs other race subgroups discontinued treatment prematurely due to AEs. The most commonly reported AEs were gastrointestinal disorders.

Conclusion(s): In this SUSTAIN trials post hoc analysis, semaglutide was associated with consistent and clinically relevant reductions in HbA1c and body weight in subjects with T2D, with minor variations in efficacy and safety outcomes associated with race or ethnicity.

Funding

Novo Nordisk