Advancing therapy in people with suboptimally controlled basal insulin-treated type 2 diabetes: Subanalysis of the SoliMix trial in participants in Latin American countries

Autores
Frechtel, Gustavo Daniel; Sauque Reyna, Leobardo; Choza Romero, Ricardo; Anguiano, Luis; Melas Melt, Lydie; Sañudo Maury, María Elena
Año de publicación
2023
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
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.
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
Fil: Sauque Reyna, Leobardo. Instituto de Diabetes, Obesidad y Nutrición; México
Fil: Choza Romero, Ricardo. Centro Médico Ono; México
Fil: Anguiano, Luis. Sanofi Pasteur; México
Fil: Melas Melt, Lydie. Ividata Life Sciences; México
Fil: Sañudo Maury, María Elena. Sanofi Pasteur; México
Materia
BASAL INSULIN
GLP-1 RECEPTOR AGONIST
SUBOPTIMAL GLYCAEMIC CONTROL
TYPE 2 DIABETES
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/212544
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/212544
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Advancing therapy in people with suboptimally controlled basal insulin-treated type 2 diabetes: Subanalysis of the SoliMix trial in participants in Latin American countriesFrechtel, Gustavo DanielSauque Reyna, LeobardoChoza Romero, RicardoAnguiano, LuisMelas Melt, LydieSañudo Maury, María ElenaBASAL INSULINGLP-1 RECEPTOR AGONISTSUBOPTIMAL GLYCAEMIC CONTROLTYPE 2 DIABETEShttps://purl.org/becyt/ford/3.2https://purl.org/becyt/ford/3Aims: 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.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; ArgentinaFil: Sauque Reyna, Leobardo. Instituto de Diabetes, Obesidad y Nutrición; MéxicoFil: Choza Romero, Ricardo. Centro Médico Ono; MéxicoFil: Anguiano, Luis. Sanofi Pasteur; MéxicoFil: Melas Melt, Lydie. Ividata Life Sciences; MéxicoFil: Sañudo Maury, María Elena. Sanofi Pasteur; MéxicoWiley Blackwell Publishing, Inc2023-05info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/212544Frechtel, 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; 2526-25341462-8902CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.15125info:eu-repo/semantics/altIdentifier/doi/10.1111/dom.15125info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T09:52:47Zoai:ri.conicet.gov.ar:11336/212544instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-03 09:52:47.397CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Advancing therapy in people with suboptimally controlled basal insulin-treated type 2 diabetes: Subanalysis of the SoliMix trial in participants in Latin American countries
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
spellingShingle Advancing therapy in people with suboptimally controlled basal insulin-treated type 2 diabetes: Subanalysis of the SoliMix trial in participants in Latin American countries
Frechtel, Gustavo Daniel
BASAL INSULIN
GLP-1 RECEPTOR AGONIST
SUBOPTIMAL GLYCAEMIC CONTROL
TYPE 2 DIABETES
title_short Advancing therapy in people with suboptimally controlled basal insulin-treated type 2 diabetes: Subanalysis of the SoliMix trial in participants in Latin American countries
title_full Advancing therapy in people with suboptimally controlled basal insulin-treated type 2 diabetes: Subanalysis of the SoliMix trial in participants in Latin American countries
title_fullStr Advancing therapy in people with suboptimally controlled basal insulin-treated type 2 diabetes: Subanalysis of the SoliMix trial in participants in Latin American countries
title_full_unstemmed Advancing therapy in people with suboptimally controlled basal insulin-treated type 2 diabetes: Subanalysis of the SoliMix trial in participants in Latin American countries
title_sort 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.creator.none.fl_str_mv Frechtel, Gustavo Daniel
Sauque Reyna, Leobardo
Choza Romero, Ricardo
Anguiano, Luis
Melas Melt, Lydie
Sañudo Maury, María Elena
author Frechtel, Gustavo Daniel
author_facet Frechtel, Gustavo Daniel
Sauque Reyna, Leobardo
Choza Romero, Ricardo
Anguiano, Luis
Melas Melt, Lydie
Sañudo Maury, María Elena
author_role author
author2 Sauque Reyna, Leobardo
Choza Romero, Ricardo
Anguiano, Luis
Melas Melt, Lydie
Sañudo Maury, María Elena
author2_role author
author
author
author
author
dc.subject.none.fl_str_mv BASAL INSULIN
GLP-1 RECEPTOR AGONIST
SUBOPTIMAL GLYCAEMIC CONTROL
TYPE 2 DIABETES
topic BASAL INSULIN
GLP-1 RECEPTOR AGONIST
SUBOPTIMAL GLYCAEMIC CONTROL
TYPE 2 DIABETES
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.2
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv 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.
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
Fil: Sauque Reyna, Leobardo. Instituto de Diabetes, Obesidad y Nutrición; México
Fil: Choza Romero, Ricardo. Centro Médico Ono; México
Fil: Anguiano, Luis. Sanofi Pasteur; México
Fil: Melas Melt, Lydie. Ividata Life Sciences; México
Fil: Sañudo Maury, María Elena. Sanofi Pasteur; México
description 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.
publishDate 2023
dc.date.none.fl_str_mv 2023-05
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/212544
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
1462-8902
CONICET Digital
CONICET
url http://hdl.handle.net/11336/212544
identifier_str_mv 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
1462-8902
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.15125
info:eu-repo/semantics/altIdentifier/doi/10.1111/dom.15125
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Wiley Blackwell Publishing, Inc
publisher.none.fl_str_mv Wiley Blackwell Publishing, Inc
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 13.13397

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