Does Gender Influence the Effectiveness and Safety of Insulin Glargine 300 U/ml in Patients with Uncontrolled Type 2 Diabetes? Results from the REALI European Pooled Analysis

Introduction: Gender differences in risk factors and treatment outcomes for type 2 diabetes mellitus (T2DM) may exist. We used the REALI European database to investigate whether there were gender-specific differences in baseline characteristics and clinical outcomes among patients with inadequately...

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Autores: Gourdy, Pierre|||0000-0002-5362-3813, Bonadonna, Riccardo C.|||0000-0002-9809-1005, Freemantle, Nick|||0000-0001-5807-5740, Mauricio, Didac|||0000-0002-2868-0250, Müller-Wieland, Dirk|||0000-0002-8807-6442, Bigot, Gregory, Mauquoi, Celine, Ciocca, Alice, Bonnemaire, Mireille
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:280880
Acceso en línea:https://ddd.uab.cat/record/280880
https://dx.doi.org/urn:doi:10.1007/s13300-021-01179-8
Access Level:acceso abierto
Palabra clave:Europe
Gender differences
Glycaemic control
Insulin glargine 300 U/ml
Pooled analysis
Type 2 diabetes
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spelling Does Gender Influence the Effectiveness and Safety of Insulin Glargine 300 U/ml in Patients with Uncontrolled Type 2 Diabetes? Results from the REALI European Pooled AnalysisGourdy, Pierre|||0000-0002-5362-3813Bonadonna, Riccardo C.|||0000-0002-9809-1005Freemantle, Nick|||0000-0001-5807-5740Mauricio, Didac|||0000-0002-2868-0250Müller-Wieland, Dirk|||0000-0002-8807-6442Bigot, GregoryMauquoi, CelineCiocca, AliceBonnemaire, MireilleEuropeGender differencesGlycaemic controlInsulin glargine 300 U/mlPooled analysisType 2 diabetesIntroduction: Gender differences in risk factors and treatment outcomes for type 2 diabetes mellitus (T2DM) may exist. We used the REALI European database to investigate whether there were gender-specific differences in baseline characteristics and clinical outcomes among patients with inadequately controlled T2DM initiated on insulin glargine 300 U/ml (Gla-300). Methods: Data were pooled from 14 multicentre, prospective, interventional and non-interventional studies. Impact of gender on glycaemic control, insulin dose, body weight and hypoglycaemia was evaluated after 12 and 24 weeks of Gla-300 treatment. Results: Women (N = 3857) were older than men (N = 4376) (median age, 65.0 versus 63.0 years), with greater mean body mass index (32.5 versus 31.6 kg/m) and lower median estimated glomerular filtration rate (77.5 versus 84.0 ml/min/1.73 m). Peripheral arterial disease and a history of myocardial infarction were more frequent in men (20.1% versus 11.7% and 12.0% versus 5.8%, respectively). At baseline, mean haemoglobin A1c (HbA1c) was 8.74% in men and 8.79% in women. Least square (LS) mean (95% CI) reduction in HbA1c from baseline to week 24 was - 1.17% (- 1.21 to - 1.13) in men and - 1.07% (- 1.11 to - 1.02) in women, resulting in a LS mean difference of - 0.10% (- 0.15 to - 0.05; p < 0.0001). At 24 weeks, 21.6% of women and 27.2% of men achieved target HbA1c of < 7.0% (p < 0.001; chi-square). Reported incidence for symptomatic (8.5% versus 8.7%) and severe (0.3% versus 0.5%) any-time-of-the-day or symptomatic (2.4% versus 1.8%) and severe (0.1% versus 0.2%) nocturnal hypoglycaemia was overall low and comparable between men and women. Changes in daily Gla-300 dose and body weight were also similar. Conclusion: Despite some gender differences in baseline characteristics, Gla-300 treatment improved glycaemic control, with overall low hypoglycaemia incidences in both men and women. However, women had statistically significantly lower HbA1c reductions than men, although these differences were clinically modest. 22022-01-0120222022-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/280880https://dx.doi.org/urn:doi:10.1007/s13300-021-01179-8reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2808802026-06-06T12:50:31Z
dc.title.none.fl_str_mv Does Gender Influence the Effectiveness and Safety of Insulin Glargine 300 U/ml in Patients with Uncontrolled Type 2 Diabetes? Results from the REALI European Pooled Analysis
title Does Gender Influence the Effectiveness and Safety of Insulin Glargine 300 U/ml in Patients with Uncontrolled Type 2 Diabetes? Results from the REALI European Pooled Analysis
spellingShingle Does Gender Influence the Effectiveness and Safety of Insulin Glargine 300 U/ml in Patients with Uncontrolled Type 2 Diabetes? Results from the REALI European Pooled Analysis
Gourdy, Pierre|||0000-0002-5362-3813
Europe
Gender differences
Glycaemic control
Insulin glargine 300 U/ml
Pooled analysis
Type 2 diabetes
title_short Does Gender Influence the Effectiveness and Safety of Insulin Glargine 300 U/ml in Patients with Uncontrolled Type 2 Diabetes? Results from the REALI European Pooled Analysis
title_full Does Gender Influence the Effectiveness and Safety of Insulin Glargine 300 U/ml in Patients with Uncontrolled Type 2 Diabetes? Results from the REALI European Pooled Analysis
title_fullStr Does Gender Influence the Effectiveness and Safety of Insulin Glargine 300 U/ml in Patients with Uncontrolled Type 2 Diabetes? Results from the REALI European Pooled Analysis
title_full_unstemmed Does Gender Influence the Effectiveness and Safety of Insulin Glargine 300 U/ml in Patients with Uncontrolled Type 2 Diabetes? Results from the REALI European Pooled Analysis
title_sort Does Gender Influence the Effectiveness and Safety of Insulin Glargine 300 U/ml in Patients with Uncontrolled Type 2 Diabetes? Results from the REALI European Pooled Analysis
dc.creator.none.fl_str_mv Gourdy, Pierre|||0000-0002-5362-3813
Bonadonna, Riccardo C.|||0000-0002-9809-1005
Freemantle, Nick|||0000-0001-5807-5740
Mauricio, Didac|||0000-0002-2868-0250
Müller-Wieland, Dirk|||0000-0002-8807-6442
Bigot, Gregory
Mauquoi, Celine
Ciocca, Alice
Bonnemaire, Mireille
author Gourdy, Pierre|||0000-0002-5362-3813
author_facet Gourdy, Pierre|||0000-0002-5362-3813
Bonadonna, Riccardo C.|||0000-0002-9809-1005
Freemantle, Nick|||0000-0001-5807-5740
Mauricio, Didac|||0000-0002-2868-0250
Müller-Wieland, Dirk|||0000-0002-8807-6442
Bigot, Gregory
Mauquoi, Celine
Ciocca, Alice
Bonnemaire, Mireille
author_role author
author2 Bonadonna, Riccardo C.|||0000-0002-9809-1005
Freemantle, Nick|||0000-0001-5807-5740
Mauricio, Didac|||0000-0002-2868-0250
Müller-Wieland, Dirk|||0000-0002-8807-6442
Bigot, Gregory
Mauquoi, Celine
Ciocca, Alice
Bonnemaire, Mireille
author2_role author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Europe
Gender differences
Glycaemic control
Insulin glargine 300 U/ml
Pooled analysis
Type 2 diabetes
topic Europe
Gender differences
Glycaemic control
Insulin glargine 300 U/ml
Pooled analysis
Type 2 diabetes
description Introduction: Gender differences in risk factors and treatment outcomes for type 2 diabetes mellitus (T2DM) may exist. We used the REALI European database to investigate whether there were gender-specific differences in baseline characteristics and clinical outcomes among patients with inadequately controlled T2DM initiated on insulin glargine 300 U/ml (Gla-300). Methods: Data were pooled from 14 multicentre, prospective, interventional and non-interventional studies. Impact of gender on glycaemic control, insulin dose, body weight and hypoglycaemia was evaluated after 12 and 24 weeks of Gla-300 treatment. Results: Women (N = 3857) were older than men (N = 4376) (median age, 65.0 versus 63.0 years), with greater mean body mass index (32.5 versus 31.6 kg/m) and lower median estimated glomerular filtration rate (77.5 versus 84.0 ml/min/1.73 m). Peripheral arterial disease and a history of myocardial infarction were more frequent in men (20.1% versus 11.7% and 12.0% versus 5.8%, respectively). At baseline, mean haemoglobin A1c (HbA1c) was 8.74% in men and 8.79% in women. Least square (LS) mean (95% CI) reduction in HbA1c from baseline to week 24 was - 1.17% (- 1.21 to - 1.13) in men and - 1.07% (- 1.11 to - 1.02) in women, resulting in a LS mean difference of - 0.10% (- 0.15 to - 0.05; p < 0.0001). At 24 weeks, 21.6% of women and 27.2% of men achieved target HbA1c of < 7.0% (p < 0.001; chi-square). Reported incidence for symptomatic (8.5% versus 8.7%) and severe (0.3% versus 0.5%) any-time-of-the-day or symptomatic (2.4% versus 1.8%) and severe (0.1% versus 0.2%) nocturnal hypoglycaemia was overall low and comparable between men and women. Changes in daily Gla-300 dose and body weight were also similar. Conclusion: Despite some gender differences in baseline characteristics, Gla-300 treatment improved glycaemic control, with overall low hypoglycaemia incidences in both men and women. However, women had statistically significantly lower HbA1c reductions than men, although these differences were clinically modest.
publishDate 2022
dc.date.none.fl_str_mv 2
2022-01-01
2022
2022-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/280880
https://dx.doi.org/urn:doi:10.1007/s13300-021-01179-8
url https://ddd.uab.cat/record/280880
https://dx.doi.org/urn:doi:10.1007/s13300-021-01179-8
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
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