Efficacy and safety of semaglutide for type 2 diabetes by race and ethnicity: a post hoc analysis of the SUSTAIN trials
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https://datadryad.org/dataset/doi:10.5061/dryad.34tmpg4fv
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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.
提供机构:
Dryad
创建时间:
2019-11-05



