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 <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 <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 >9.0%: -1.7% to -2.6%; HbA1c <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
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30202 - Endocrinology and metabolism (including diabetes, hormones)
Result continuities
Project
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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