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Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study—UPDATES Saudi Arabia

INTRODUCTION: Insulin degludec (degludec) has proven benefits in type 2 diabetes (T2D), in terms of improved glycaemic control, low risk of hypoglycaemia, and flexibility in dosing time. This prospective non-interventional UPDATES study aimed to investigate whether results obtained from randomised c...

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Autores principales: AlMalki, Mussa H., Aldesokey, Hossam, Alkhafaji, Dania, Alsheikh, Abdulrahman, Braae, Uffe Christian, Lehrskov, Lars Lang, Magawry, Waleed, Yahia, Moataz, Haroun, Ahmed
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9685061/
https://www.ncbi.nlm.nih.gov/pubmed/36417058
http://dx.doi.org/10.1007/s12325-022-02366-0
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author AlMalki, Mussa H.
Aldesokey, Hossam
Alkhafaji, Dania
Alsheikh, Abdulrahman
Braae, Uffe Christian
Lehrskov, Lars Lang
Magawry, Waleed
Yahia, Moataz
Haroun, Ahmed
author_facet AlMalki, Mussa H.
Aldesokey, Hossam
Alkhafaji, Dania
Alsheikh, Abdulrahman
Braae, Uffe Christian
Lehrskov, Lars Lang
Magawry, Waleed
Yahia, Moataz
Haroun, Ahmed
author_sort AlMalki, Mussa H.
collection PubMed
description INTRODUCTION: Insulin degludec (degludec) has proven benefits in type 2 diabetes (T2D), in terms of improved glycaemic control, low risk of hypoglycaemia, and flexibility in dosing time. This prospective non-interventional UPDATES study aimed to investigate whether results obtained from randomised clinical trials and other real-world studies with degludec are generalisable to patients with T2D in routine clinical practice in Saudi Arabia. METHODS: Eligible adults (n = 561) with T2D received degludec for 26–34 weeks, at physicians’ discretion and in accordance with local routine clinical practice. The primary endpoint was mean change in HbA(1c) from baseline to end of study (EOS). Secondary endpoints included mean change from baseline to EOS in fasting plasma glucose (FPG), daily insulin dose and rate of hypoglycaemia. RESULTS: At baseline, mean age, HbA(1c) and FPG were 55.7 years, 9.4% and 185.6 mg/dL, respectively. Mean (standard error [SE]) changes from baseline to EOS (crude analysis) were statistically significant for HbA(1c) (− 1.1 [0.08] %-points, 95% CI − 1.29, − 0.98; P < 0.0001), FPG (− 39.1 [3.42] mg/dL, 95% CI − 45.9, − 32.4; P < 0.0001) and total daily insulin dose (+ 4.7 [1.6] units, 95% CI 1.63, 7.86; P = 0.003, insulin-experienced population). In exploratory analysis of patients switching from insulin glargine U100 or U300 to degludec, similar reductions were seen in HbA(1c) and FPG. The rate of hypoglycaemia was significantly reduced with degludec versus previous treatment, with no apparent or unexpected safety and tolerability issues. The number of insulin-experienced patients utilising resources associated with severe hypoglycaemia was also reduced. Most patients (95.5%) were willing to continue treatment at EOS, and expressed a preference for degludec over their previous regimen (93.0%). CONCLUSION: Patients with T2D treated with degludec in routine clinical practice in Saudi Arabia experienced clinically significant improvements in glycaemic control and a lower rate of hypoglycaemia compared with baseline, with no new safety concerns reported. CLINICAL TRIAL REGISTRATION: NCT03785522. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-022-02366-0.
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spelling pubmed-96850612022-11-28 Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study—UPDATES Saudi Arabia AlMalki, Mussa H. Aldesokey, Hossam Alkhafaji, Dania Alsheikh, Abdulrahman Braae, Uffe Christian Lehrskov, Lars Lang Magawry, Waleed Yahia, Moataz Haroun, Ahmed Adv Ther Original Research INTRODUCTION: Insulin degludec (degludec) has proven benefits in type 2 diabetes (T2D), in terms of improved glycaemic control, low risk of hypoglycaemia, and flexibility in dosing time. This prospective non-interventional UPDATES study aimed to investigate whether results obtained from randomised clinical trials and other real-world studies with degludec are generalisable to patients with T2D in routine clinical practice in Saudi Arabia. METHODS: Eligible adults (n = 561) with T2D received degludec for 26–34 weeks, at physicians’ discretion and in accordance with local routine clinical practice. The primary endpoint was mean change in HbA(1c) from baseline to end of study (EOS). Secondary endpoints included mean change from baseline to EOS in fasting plasma glucose (FPG), daily insulin dose and rate of hypoglycaemia. RESULTS: At baseline, mean age, HbA(1c) and FPG were 55.7 years, 9.4% and 185.6 mg/dL, respectively. Mean (standard error [SE]) changes from baseline to EOS (crude analysis) were statistically significant for HbA(1c) (− 1.1 [0.08] %-points, 95% CI − 1.29, − 0.98; P < 0.0001), FPG (− 39.1 [3.42] mg/dL, 95% CI − 45.9, − 32.4; P < 0.0001) and total daily insulin dose (+ 4.7 [1.6] units, 95% CI 1.63, 7.86; P = 0.003, insulin-experienced population). In exploratory analysis of patients switching from insulin glargine U100 or U300 to degludec, similar reductions were seen in HbA(1c) and FPG. The rate of hypoglycaemia was significantly reduced with degludec versus previous treatment, with no apparent or unexpected safety and tolerability issues. The number of insulin-experienced patients utilising resources associated with severe hypoglycaemia was also reduced. Most patients (95.5%) were willing to continue treatment at EOS, and expressed a preference for degludec over their previous regimen (93.0%). CONCLUSION: Patients with T2D treated with degludec in routine clinical practice in Saudi Arabia experienced clinically significant improvements in glycaemic control and a lower rate of hypoglycaemia compared with baseline, with no new safety concerns reported. CLINICAL TRIAL REGISTRATION: NCT03785522. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-022-02366-0. Springer Healthcare 2022-11-22 2023 /pmc/articles/PMC9685061/ /pubmed/36417058 http://dx.doi.org/10.1007/s12325-022-02366-0 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis 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/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
AlMalki, Mussa H.
Aldesokey, Hossam
Alkhafaji, Dania
Alsheikh, Abdulrahman
Braae, Uffe Christian
Lehrskov, Lars Lang
Magawry, Waleed
Yahia, Moataz
Haroun, Ahmed
Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study—UPDATES Saudi Arabia
title Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study—UPDATES Saudi Arabia
title_full Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study—UPDATES Saudi Arabia
title_fullStr Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study—UPDATES Saudi Arabia
title_full_unstemmed Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study—UPDATES Saudi Arabia
title_short Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study—UPDATES Saudi Arabia
title_sort glycaemic control in people with type 2 diabetes treated with insulin degludec: a real-world, prospective non-interventional study—updates saudi arabia
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9685061/
https://www.ncbi.nlm.nih.gov/pubmed/36417058
http://dx.doi.org/10.1007/s12325-022-02366-0
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