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Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F22%3A00082914" target="_blank" >RIV/00023001:_____/22:00082914 - isvavai.cz</a>

  • Result on the web

    <a href="https://dom-pubs.onlinelibrary.wiley.com/doi/epdf/10.1111/dom.14710" target="_blank" >https://dom-pubs.onlinelibrary.wiley.com/doi/epdf/10.1111/dom.14710</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1111/dom.14710" target="_blank" >10.1111/dom.14710</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

    Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme

  • Original language description

    Aims To evaluate the efficacy and safety of oral semaglutide versus comparators by patient characteristic subgroups in patients with type 2 diabetes. Materials and Methods Change from baseline in glycated haemoglobin (HbA1c) and body weight, and achievement of HbA1c &lt;7.0% with oral semaglutide 7 mg, oral semaglutide 14 mg, flexibly dosed oral semaglutide (flex) and comparators were assessed across baseline subgroups (age, race, ethnicity, diabetes duration, body mass index and HbA1c) from the PIONEER programme. Treatment differences were analysed using a mixed model for repeated measurements for continuous variables and a logistic regression model for the binary endpoint. Pooled safety data were analysed descriptively. Results Changes from baseline in HbA1c and body weight, and the odds of achieving HbA1c &lt;7.0%, were greater with oral semaglutide 14 mg/flex (n = 1934) and higher or similar with oral semaglutide 7 mg (n = 823) versus comparators (n = 2077) across most subgroups. Changes in HbA1c with oral semaglutide 14 mg/flex were greater for patients with higher baseline HbA1c (HbA1c &gt;9.0%: -1.7% to -2.6%; HbA1c &lt;8.0%: -0.7% to -1.2%). In some trials, Asian patients experienced greater HbA1c reductions with oral semaglutide 14 mg/flex (-1.5% to -1.8%) than other racial groups (-0.6% to -1.6%). The overall incidence of adverse events (AEs) with oral semaglutide was similar to that with comparators and was consistent across subgroups. More gastrointestinal AEs were observed with oral semaglutide, versus comparators, across subgroups. Conclusions Oral semaglutide demonstrated consistently greater HbA1c and body weight reductions across a range of patient characteristics, with greater HbA1c reductions seen at higher baseline HbA1c levels.

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30202 - Endocrinology and metabolism (including diabetes, hormones)

Result continuities

  • Project

  • Continuities

    N - Vyzkumna aktivita podporovana z neverejnych zdroju

Others

  • Publication year

    2022

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    Diabetes, obesity and metabolism

  • ISSN

    1462-8902

  • e-ISSN

    1463-1326

  • Volume of the periodical

    24

  • Issue of the periodical within the volume

    7

  • Country of publishing house

    GB - UNITED KINGDOM

  • Number of pages

    13

  • Pages from-to

    1338-1350

  • UT code for WoS article

    000792511300001

  • EID of the result in the Scopus database

    2-s2.0-85129593478