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dc.contributor.author
Frechtel, Gustavo Daniel
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Sauque Reyna, Leobardo
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Choza Romero, Ricardo
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Anguiano, Luis
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Melas Melt, Lydie
dc.contributor.author
Sañudo Maury, María Elena
dc.date.available
2023-09-21T15:38:06Z
dc.date.issued
2023-05
dc.identifier.citation
Frechtel, Gustavo Daniel; Sauque Reyna, Leobardo; Choza Romero, Ricardo; Anguiano, Luis; Melas Melt, Lydie; et al.; Advancing therapy in people with suboptimally controlled basal insulin-treated type 2 diabetes: Subanalysis of the SoliMix trial in participants in Latin American countries; Wiley Blackwell Publishing, Inc; Diabetes Obesity & Metabolism; 25; 9; 5-2023; 2526-2534
dc.identifier.issn
1462-8902
dc.identifier.uri
http://hdl.handle.net/11336/212544
dc.description.abstract
Aims: This subanalysis of the SoliMix trial assessed the efficacy and safety of advancing basal insulin (BI) therapy with iGlarLixi versus BIAsp 30 in people with type 2 diabetes (T2D) living in Latin American (LATAM) countries, i.e. Argentina and Mexico (N = 160). Materials and Methods: SoliMix (EudraCT: 2017-003370-13) was a 26-week, open-label, multicentre study, where adults with T2D suboptimally controlled with BI plus one or two oral glucose-lowering drugs and glycated haemoglobin (HbA1c) ≥7.5% to ≤10% were randomized to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy endpoints were non-inferiority in HbA1c reduction (margin 0.3%) or superiority in body weight change for iGlarLixi versus BIAsp 30. Results: Both primary efficacy endpoints were met in the LATAM region. After 26 weeks, HbA1c was reduced by 1.8% with iGlarLixi and 1.4% with BIAsp 30, meeting non-inferiority [least squares mean difference −0.47% (95% confidence interval: −0.82, −0.11); p <.001]. iGlarLixi was superior to BIAsp 30 for body weight change [least squares mean difference −1.27% (95% confidence interval: −2.41, −0.14); p =.028]. iGlarLixi was also superior to BIAsp 30 for HbA1c reduction (p =.010). A greater proportion of participants achieved HbA1c <7% without weight gain and HbA1c <7% without weight gain and without hypoglycaemia with iGlarLixi versus BIAsp 30. Incidence and rates of American Diabetes Association Level 1 and 2 hypoglycaemia were lower with iGlarLixi versus BIAsp 30. Conclusions: Once-daily iGlarLixi provided better glycaemic control with weight benefit and less hypoglycaemia than twice-daily premix BIAsp 30. iGlarLixi may be a favourable alternative to premix BIAsp 30 in people with suboptimally controlled T2D to advance BI therapy in the LATAM region.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Wiley Blackwell Publishing, Inc
dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.subject
BASAL INSULIN
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GLP-1 RECEPTOR AGONIST
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SUBOPTIMAL GLYCAEMIC CONTROL
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TYPE 2 DIABETES
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Endocrinología y Metabolismo
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Medicina Clínica
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CIENCIAS MÉDICAS Y DE LA SALUD
dc.title
Advancing therapy in people with suboptimally controlled basal insulin-treated type 2 diabetes: Subanalysis of the SoliMix trial in participants in Latin American countries
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2023-09-15T11:28:52Z
dc.journal.volume
25
dc.journal.number
9
dc.journal.pagination
2526-2534
dc.journal.pais
Reino Unido
dc.journal.ciudad
Londres
dc.description.fil
Fil: Frechtel, Gustavo Daniel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Inmunología, Genética y Metabolismo. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Inmunología, Genética y Metabolismo; Argentina
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Fil: Sauque Reyna, Leobardo. Instituto de Diabetes, Obesidad y Nutrición; México
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Fil: Choza Romero, Ricardo. Centro Médico Ono; México
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Fil: Anguiano, Luis. Sanofi Pasteur; México
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Fil: Melas Melt, Lydie. Ividata Life Sciences; México
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Fil: Sañudo Maury, María Elena. Sanofi Pasteur; México
dc.journal.title
Diabetes Obesity & Metabolism
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.15125
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1111/dom.15125
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