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Glycaemic Control with Insulin Glargine 300 U/mL in Individuals with Type 2 Diabetes and Chronic Kidney Disease: A REALI European Pooled Data Analysis
INTRODUCTION: Management of type 2 diabetes mellitus (T2DM) in patients with chronic kidney disease is complex. Using the REALI European pooled database, we determined the impact of baseline renal function on the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) initiated in adults wit...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7994474/ https://www.ncbi.nlm.nih.gov/pubmed/33751403 http://dx.doi.org/10.1007/s13300-021-01031-z |
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author | Mauricio, Didac Gourdy, Pierre Bonadonna, Riccardo C. Freemantle, Nick Bigot, Gregory Mauquoi, Celine Ciocca, Alice Bonnemaire, Mireille Müller-Wieland, Dirk |
author_facet | Mauricio, Didac Gourdy, Pierre Bonadonna, Riccardo C. Freemantle, Nick Bigot, Gregory Mauquoi, Celine Ciocca, Alice Bonnemaire, Mireille Müller-Wieland, Dirk |
author_sort | Mauricio, Didac |
collection | PubMed |
description | INTRODUCTION: Management of type 2 diabetes mellitus (T2DM) in patients with chronic kidney disease is complex. Using the REALI European pooled database, we determined the impact of baseline renal function on the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) initiated in adults with inadequately controlled T2DM. METHODS: Data from 1712 patients with available estimated glomerular filtration rate (eGFR) at baseline were pooled from six 24-week prospective studies. Patients who received once-daily subcutaneous injections of Gla-300 were classified into four renal function subgroups, according to baseline eGFR: ≥ 90 (N = 599), 60–89 (N = 786), 45–59 (N = 219), and 15–44 mL/min/1.73 m(2) (N = 108). RESULTS: Compared to those with baseline eGFR ≥ 60 mL/min/1.73 m(2), patients with lower eGFR values tended to be older, had a longer T2DM duration, and were more likely to present diabetic complications. After 24 weeks of Gla-300 therapy, the least-squares mean (95% confidence interval) decrease in haemoglobin A1c (HbA1c) from baseline (− 1.14% [− 1.28 to − 1.00], − 1.21% [− 1.34 to − 1.08], − 1.19% [− 1.36 to − 1.01], and − 0.99% [− 1.22 to − 0.76]) and the proportion of patients achieving HbA1c < 7.5% (53.3%, 51.3%, 49.5%, and 51.5%) were comparable in the ≥ 90, 60–89, 45–59, and 15–44 mL/min/1.73 m(2) subgroups, respectively. Although the incidence of hypoglycaemia was overall low, more patients in the eGFR 15–44 mL/min/1.73 m(2) subgroup experienced hypoglycaemia at night or at any time of the day compared with higher eGFR subgroups. There were no notable differences between the renal function subgroups in the changes in Gla-300 daily dose and body weight from baseline to week 24. CONCLUSION: Although an eGFR of 15–44 mL/min/1.73 m(2) was associated with a slightly increased risk of hypoglycaemia among patients with inadequately controlled T2DM, Gla-300 provided glycaemic improvement with an overall favourable safety profile regardless of baseline eGFR. |
format | Online Article Text |
id | pubmed-7994474 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-79944742021-04-16 Glycaemic Control with Insulin Glargine 300 U/mL in Individuals with Type 2 Diabetes and Chronic Kidney Disease: A REALI European Pooled Data Analysis Mauricio, Didac Gourdy, Pierre Bonadonna, Riccardo C. Freemantle, Nick Bigot, Gregory Mauquoi, Celine Ciocca, Alice Bonnemaire, Mireille Müller-Wieland, Dirk Diabetes Ther Original Research INTRODUCTION: Management of type 2 diabetes mellitus (T2DM) in patients with chronic kidney disease is complex. Using the REALI European pooled database, we determined the impact of baseline renal function on the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) initiated in adults with inadequately controlled T2DM. METHODS: Data from 1712 patients with available estimated glomerular filtration rate (eGFR) at baseline were pooled from six 24-week prospective studies. Patients who received once-daily subcutaneous injections of Gla-300 were classified into four renal function subgroups, according to baseline eGFR: ≥ 90 (N = 599), 60–89 (N = 786), 45–59 (N = 219), and 15–44 mL/min/1.73 m(2) (N = 108). RESULTS: Compared to those with baseline eGFR ≥ 60 mL/min/1.73 m(2), patients with lower eGFR values tended to be older, had a longer T2DM duration, and were more likely to present diabetic complications. After 24 weeks of Gla-300 therapy, the least-squares mean (95% confidence interval) decrease in haemoglobin A1c (HbA1c) from baseline (− 1.14% [− 1.28 to − 1.00], − 1.21% [− 1.34 to − 1.08], − 1.19% [− 1.36 to − 1.01], and − 0.99% [− 1.22 to − 0.76]) and the proportion of patients achieving HbA1c < 7.5% (53.3%, 51.3%, 49.5%, and 51.5%) were comparable in the ≥ 90, 60–89, 45–59, and 15–44 mL/min/1.73 m(2) subgroups, respectively. Although the incidence of hypoglycaemia was overall low, more patients in the eGFR 15–44 mL/min/1.73 m(2) subgroup experienced hypoglycaemia at night or at any time of the day compared with higher eGFR subgroups. There were no notable differences between the renal function subgroups in the changes in Gla-300 daily dose and body weight from baseline to week 24. CONCLUSION: Although an eGFR of 15–44 mL/min/1.73 m(2) was associated with a slightly increased risk of hypoglycaemia among patients with inadequately controlled T2DM, Gla-300 provided glycaemic improvement with an overall favourable safety profile regardless of baseline eGFR. Springer Healthcare 2021-03-09 2021-04 /pmc/articles/PMC7994474/ /pubmed/33751403 http://dx.doi.org/10.1007/s13300-021-01031-z Text en © The Author(s) 2021 Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial 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-nc/4.0/. |
spellingShingle | Original Research Mauricio, Didac Gourdy, Pierre Bonadonna, Riccardo C. Freemantle, Nick Bigot, Gregory Mauquoi, Celine Ciocca, Alice Bonnemaire, Mireille Müller-Wieland, Dirk Glycaemic Control with Insulin Glargine 300 U/mL in Individuals with Type 2 Diabetes and Chronic Kidney Disease: A REALI European Pooled Data Analysis |
title | Glycaemic Control with Insulin Glargine 300 U/mL in Individuals with Type 2 Diabetes and Chronic Kidney Disease: A REALI European Pooled Data Analysis |
title_full | Glycaemic Control with Insulin Glargine 300 U/mL in Individuals with Type 2 Diabetes and Chronic Kidney Disease: A REALI European Pooled Data Analysis |
title_fullStr | Glycaemic Control with Insulin Glargine 300 U/mL in Individuals with Type 2 Diabetes and Chronic Kidney Disease: A REALI European Pooled Data Analysis |
title_full_unstemmed | Glycaemic Control with Insulin Glargine 300 U/mL in Individuals with Type 2 Diabetes and Chronic Kidney Disease: A REALI European Pooled Data Analysis |
title_short | Glycaemic Control with Insulin Glargine 300 U/mL in Individuals with Type 2 Diabetes and Chronic Kidney Disease: A REALI European Pooled Data Analysis |
title_sort | glycaemic control with insulin glargine 300 u/ml in individuals with type 2 diabetes and chronic kidney disease: a reali european pooled data analysis |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7994474/ https://www.ncbi.nlm.nih.gov/pubmed/33751403 http://dx.doi.org/10.1007/s13300-021-01031-z |
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