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Impact of Insulin Degludec in Type 2 Diabetes: Real-World Data on Effectiveness and Safety

INTRODUCTION: Real-world evidence on effectiveness and safety of insulin degludec (IDeg) in patients with diabetes is a priority. The aim of the study was to evaluate patterns of use and the long-term effectiveness and safety of IDeg in routine clinical practice. METHODS: This was an observational l...

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Autores principales: Ponzani, Paola, Berra, Cesare, Di Lelio, Alessandra, Del Sindaco, Paola, Di Loreto, Chiara, Reggiani, Francesco, Lucisano, Giuseppe, Rossi, Maria Chiara
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6250625/
https://www.ncbi.nlm.nih.gov/pubmed/30242611
http://dx.doi.org/10.1007/s13300-018-0511-4
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author Ponzani, Paola
Berra, Cesare
Di Lelio, Alessandra
Del Sindaco, Paola
Di Loreto, Chiara
Reggiani, Francesco
Lucisano, Giuseppe
Rossi, Maria Chiara
author_facet Ponzani, Paola
Berra, Cesare
Di Lelio, Alessandra
Del Sindaco, Paola
Di Loreto, Chiara
Reggiani, Francesco
Lucisano, Giuseppe
Rossi, Maria Chiara
author_sort Ponzani, Paola
collection PubMed
description INTRODUCTION: Real-world evidence on effectiveness and safety of insulin degludec (IDeg) in patients with diabetes is a priority. The aim of the study was to evaluate patterns of use and the long-term effectiveness and safety of IDeg in routine clinical practice. METHODS: This was an observational longitudinal study. A retrospective chart review of all patients with type 2 diabetes treated with IDeg was performed and temporal trends in clinical outcomes were assessed. All data was stratified by treatment modality: the switch group consisted of patients already treated with another basal insulin before initiating IDeg; the add-on group consisted of basal insulin-naïve patients. RESULTS: Overall, 247 patients were analyzed (55 in the add-on group and 192 in the switch group), mean age 67.0 ± 10.9 years ,and diabetes duration 16.3 ± 8.9 years. Median (interquartile range) follow-up was 9.7 (8.0–11.9) months. In the add-on group, improvements were found in glycated hemoglobin (HbA1c) (– 1.68%; p < 0.0001), fasting blood glucose (FBG) (– 64.7 mg/dL; p < 0.0001), post-prandial glucose (PPG) (– 81.1 mg/dl; p < 0.0001), and glycemic variability (i.e., standard deviation of blood glucose) (– 11.6 mg/dl; p = 0.04). Even in the switch group, improvements were found in HbA1c (– 0.57%; p < 0.0001), FBG (– 28.1 mg/dL; p < 0.0001), and PPG (– 22.6 mg/dl; p = 0.001). Body weight increase during the follow-up was not statistically significant vs. baseline in both groups. Benefits on overall, nocturnal, and severe hypoglycemia were found in the switch group. CONCLUSION: These real-world data documented that initiating IDeg or switching to IDeg from other basal insulins in type 2 diabetes was associated with significant improvement in metabolic control without significant weight gain; a decrease in the risk of hypoglycemia was observed when switching to IDeg from another basal insulin. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13300-018-0511-4) contains supplementary material, which is available to authorized users.
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spelling pubmed-62506252018-12-07 Impact of Insulin Degludec in Type 2 Diabetes: Real-World Data on Effectiveness and Safety Ponzani, Paola Berra, Cesare Di Lelio, Alessandra Del Sindaco, Paola Di Loreto, Chiara Reggiani, Francesco Lucisano, Giuseppe Rossi, Maria Chiara Diabetes Ther Original Research INTRODUCTION: Real-world evidence on effectiveness and safety of insulin degludec (IDeg) in patients with diabetes is a priority. The aim of the study was to evaluate patterns of use and the long-term effectiveness and safety of IDeg in routine clinical practice. METHODS: This was an observational longitudinal study. A retrospective chart review of all patients with type 2 diabetes treated with IDeg was performed and temporal trends in clinical outcomes were assessed. All data was stratified by treatment modality: the switch group consisted of patients already treated with another basal insulin before initiating IDeg; the add-on group consisted of basal insulin-naïve patients. RESULTS: Overall, 247 patients were analyzed (55 in the add-on group and 192 in the switch group), mean age 67.0 ± 10.9 years ,and diabetes duration 16.3 ± 8.9 years. Median (interquartile range) follow-up was 9.7 (8.0–11.9) months. In the add-on group, improvements were found in glycated hemoglobin (HbA1c) (– 1.68%; p < 0.0001), fasting blood glucose (FBG) (– 64.7 mg/dL; p < 0.0001), post-prandial glucose (PPG) (– 81.1 mg/dl; p < 0.0001), and glycemic variability (i.e., standard deviation of blood glucose) (– 11.6 mg/dl; p = 0.04). Even in the switch group, improvements were found in HbA1c (– 0.57%; p < 0.0001), FBG (– 28.1 mg/dL; p < 0.0001), and PPG (– 22.6 mg/dl; p = 0.001). Body weight increase during the follow-up was not statistically significant vs. baseline in both groups. Benefits on overall, nocturnal, and severe hypoglycemia were found in the switch group. CONCLUSION: These real-world data documented that initiating IDeg or switching to IDeg from other basal insulins in type 2 diabetes was associated with significant improvement in metabolic control without significant weight gain; a decrease in the risk of hypoglycemia was observed when switching to IDeg from another basal insulin. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13300-018-0511-4) contains supplementary material, which is available to authorized users. Springer Healthcare 2018-09-21 2018-12 /pmc/articles/PMC6250625/ /pubmed/30242611 http://dx.doi.org/10.1007/s13300-018-0511-4 Text en © The Author(s) 2018 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research
Ponzani, Paola
Berra, Cesare
Di Lelio, Alessandra
Del Sindaco, Paola
Di Loreto, Chiara
Reggiani, Francesco
Lucisano, Giuseppe
Rossi, Maria Chiara
Impact of Insulin Degludec in Type 2 Diabetes: Real-World Data on Effectiveness and Safety
title Impact of Insulin Degludec in Type 2 Diabetes: Real-World Data on Effectiveness and Safety
title_full Impact of Insulin Degludec in Type 2 Diabetes: Real-World Data on Effectiveness and Safety
title_fullStr Impact of Insulin Degludec in Type 2 Diabetes: Real-World Data on Effectiveness and Safety
title_full_unstemmed Impact of Insulin Degludec in Type 2 Diabetes: Real-World Data on Effectiveness and Safety
title_short Impact of Insulin Degludec in Type 2 Diabetes: Real-World Data on Effectiveness and Safety
title_sort impact of insulin degludec in type 2 diabetes: real-world data on effectiveness and safety
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6250625/
https://www.ncbi.nlm.nih.gov/pubmed/30242611
http://dx.doi.org/10.1007/s13300-018-0511-4
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