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Similar glycaemic control and risk of hypoglycaemia with patient- versus physician-managed titration of insulin glargine 300 U/mL across subgroups of patients with T2DM: a post hoc analysis of ITAS

AIMS: The Italian Titration Approach Study (ITAS) demonstrated comparable HbA(1c) reductions and similarly low hypoglycaemia risk at 6 months in poorly controlled, insulin-naïve adults with T2DM who initiated self- or physician-titrated insulin glargine 300 U/mL (Gla-300) in the absence of sulphonyl...

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Autores principales: Giaccari, Andrea, Bonadonna, R. C., Buzzetti, R., Perseghin, G., Cucinotta, D., Fanelli, C., Avogaro, A., Aimaretti, G., Larosa, M., Pagano, V., Bolli, G. B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Milan 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8110495/
https://www.ncbi.nlm.nih.gov/pubmed/33586058
http://dx.doi.org/10.1007/s00592-021-01675-0
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author Giaccari, Andrea
Bonadonna, R. C.
Buzzetti, R.
Perseghin, G.
Cucinotta, D.
Fanelli, C.
Avogaro, A.
Aimaretti, G.
Larosa, M.
Pagano, V.
Bolli, G. B.
author_facet Giaccari, Andrea
Bonadonna, R. C.
Buzzetti, R.
Perseghin, G.
Cucinotta, D.
Fanelli, C.
Avogaro, A.
Aimaretti, G.
Larosa, M.
Pagano, V.
Bolli, G. B.
author_sort Giaccari, Andrea
collection PubMed
description AIMS: The Italian Titration Approach Study (ITAS) demonstrated comparable HbA(1c) reductions and similarly low hypoglycaemia risk at 6 months in poorly controlled, insulin-naïve adults with T2DM who initiated self- or physician-titrated insulin glargine 300 U/mL (Gla-300) in the absence of sulphonylurea/glinide. The association of patient characteristics with glycaemic and hypoglycaemic outcomes was assessed. METHODS: This post hoc analysis investigated whether baseline patient characteristics and previous antihyperglycaemic drugs were associated with HbA(1c) change and hypoglycaemia risk in patient- versus physician-managed Gla-300 titration. RESULTS: HbA(1c) change, incidence of hypoglycaemia (any type) and nocturnal rates were comparable between patient- and physician-managed arms in all subgroups. Hypoglycaemia rates across subgroups (0.03 to 3.52 events per patient-year) were generally as low as observed in the full ITAS population. Small increases in rates of 00:00–pre-breakfast and anytime hypoglycaemia were observed in the ≤ 10-year diabetes duration subgroup in the patient- versus physician-managed arm (heterogeneity of effect; p < 0.05). CONCLUSIONS: Comparably fair glycaemic control and similarly low hypoglycaemia risk were achieved in almost all patient subgroups with patient- versus physician-led Gla-300 titration. These results reinforce efficacy and safety of Gla-300 self-titration across a range of phenotypes of insulin-naïve people with T2DM. CLINICAL TRIAL REGISTRATION: EudraCT 2015-001167-39 SUPPLEMENTARY INFORMATION: The online version of this article (10.1007/s00592-021-01675-0) contains supplementary material, which is available to authorized users.
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spelling pubmed-81104952021-05-12 Similar glycaemic control and risk of hypoglycaemia with patient- versus physician-managed titration of insulin glargine 300 U/mL across subgroups of patients with T2DM: a post hoc analysis of ITAS Giaccari, Andrea Bonadonna, R. C. Buzzetti, R. Perseghin, G. Cucinotta, D. Fanelli, C. Avogaro, A. Aimaretti, G. Larosa, M. Pagano, V. Bolli, G. B. Acta Diabetol Original Article AIMS: The Italian Titration Approach Study (ITAS) demonstrated comparable HbA(1c) reductions and similarly low hypoglycaemia risk at 6 months in poorly controlled, insulin-naïve adults with T2DM who initiated self- or physician-titrated insulin glargine 300 U/mL (Gla-300) in the absence of sulphonylurea/glinide. The association of patient characteristics with glycaemic and hypoglycaemic outcomes was assessed. METHODS: This post hoc analysis investigated whether baseline patient characteristics and previous antihyperglycaemic drugs were associated with HbA(1c) change and hypoglycaemia risk in patient- versus physician-managed Gla-300 titration. RESULTS: HbA(1c) change, incidence of hypoglycaemia (any type) and nocturnal rates were comparable between patient- and physician-managed arms in all subgroups. Hypoglycaemia rates across subgroups (0.03 to 3.52 events per patient-year) were generally as low as observed in the full ITAS population. Small increases in rates of 00:00–pre-breakfast and anytime hypoglycaemia were observed in the ≤ 10-year diabetes duration subgroup in the patient- versus physician-managed arm (heterogeneity of effect; p < 0.05). CONCLUSIONS: Comparably fair glycaemic control and similarly low hypoglycaemia risk were achieved in almost all patient subgroups with patient- versus physician-led Gla-300 titration. These results reinforce efficacy and safety of Gla-300 self-titration across a range of phenotypes of insulin-naïve people with T2DM. CLINICAL TRIAL REGISTRATION: EudraCT 2015-001167-39 SUPPLEMENTARY INFORMATION: The online version of this article (10.1007/s00592-021-01675-0) contains supplementary material, which is available to authorized users. Springer Milan 2021-02-14 2021 /pmc/articles/PMC8110495/ /pubmed/33586058 http://dx.doi.org/10.1007/s00592-021-01675-0 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Article
Giaccari, Andrea
Bonadonna, R. C.
Buzzetti, R.
Perseghin, G.
Cucinotta, D.
Fanelli, C.
Avogaro, A.
Aimaretti, G.
Larosa, M.
Pagano, V.
Bolli, G. B.
Similar glycaemic control and risk of hypoglycaemia with patient- versus physician-managed titration of insulin glargine 300 U/mL across subgroups of patients with T2DM: a post hoc analysis of ITAS
title Similar glycaemic control and risk of hypoglycaemia with patient- versus physician-managed titration of insulin glargine 300 U/mL across subgroups of patients with T2DM: a post hoc analysis of ITAS
title_full Similar glycaemic control and risk of hypoglycaemia with patient- versus physician-managed titration of insulin glargine 300 U/mL across subgroups of patients with T2DM: a post hoc analysis of ITAS
title_fullStr Similar glycaemic control and risk of hypoglycaemia with patient- versus physician-managed titration of insulin glargine 300 U/mL across subgroups of patients with T2DM: a post hoc analysis of ITAS
title_full_unstemmed Similar glycaemic control and risk of hypoglycaemia with patient- versus physician-managed titration of insulin glargine 300 U/mL across subgroups of patients with T2DM: a post hoc analysis of ITAS
title_short Similar glycaemic control and risk of hypoglycaemia with patient- versus physician-managed titration of insulin glargine 300 U/mL across subgroups of patients with T2DM: a post hoc analysis of ITAS
title_sort similar glycaemic control and risk of hypoglycaemia with patient- versus physician-managed titration of insulin glargine 300 u/ml across subgroups of patients with t2dm: a post hoc analysis of itas
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8110495/
https://www.ncbi.nlm.nih.gov/pubmed/33586058
http://dx.doi.org/10.1007/s00592-021-01675-0
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