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Region Hovedstaden - en del af Københavns Universitetshospital
E-pub ahead of print

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  • Vanita R Aroda
  • Matthew S Capehorn
  • Louis Chaykin
  • Juan P Frias
  • Nanna L Lausvig
  • Stanislava Macura
  • Jörg Lüdemann
  • Sten Madsbad
  • Julio Rosenstock
  • Omur Tabak
  • Sayeh Tadayon
  • Stephen C Bain
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AIMS: We evaluated the impact of relevant patient-level characteristics on the efficacy and safety of subcutaneous, once-weekly semaglutide in subjects with T2D.

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 <7.0% [53 mmol/mol], without weight gain or severe/blood glucose-confirmed symptomatic hypoglycaemia) at week 30 with semaglutide (0.5/1.0 mg) across clinically relevant patient subgroups: baseline HbA1c (≤7.5, >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<0.001], respectively). HbA1c and BW reductions were consistently greater for semaglutide 1.0 mg versus 0.5 mg across background medication, diabetes duration and pancreatic beta-cell function subgroups. Adverse events with semaglutide were consistent with the GLP-1RA class, with gastrointestinal events the most common.

CONCLUSIONS: Semaglutide was consistently efficacious across the continuum of diabetes care in a broad spectrum of patient subgroups with a range of clinical characteristics. This article is protected by copyright. All rights reserved.

OriginalsprogEngelsk
TidsskriftDiabetes, Obesity and Metabolism
ISSN1462-8902
DOI
StatusE-pub ahead of print - 13 okt. 2019

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This article is protected by copyright. All rights reserved.

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