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Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries

INTRODUCTION: Insulin degludec/insulin aspart (IDegAsp) is a fixed-ratio co-formulation of insulin degludec (a basal insulin) and insulin aspart (a prandial insulin). The aim of this study was to investigate clinical outcomes in people with type 2 diabetes (T2D) after initiating IDegAsp treatment in...

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Autores principales: Fulcher, Gregory R., Akhtar, Shahid, Al-Jaser, Saleh J., Medina, Johan, Mohamed, Mafauzy, Nicodemus, Nemencio A., Olsen, Anne Helene, Singh, Kiran P., Kok, Adri
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9244059/
https://www.ncbi.nlm.nih.gov/pubmed/35752730
http://dx.doi.org/10.1007/s12325-022-02212-3
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author Fulcher, Gregory R.
Akhtar, Shahid
Al-Jaser, Saleh J.
Medina, Johan
Mohamed, Mafauzy
Nicodemus, Nemencio A.
Olsen, Anne Helene
Singh, Kiran P.
Kok, Adri
author_facet Fulcher, Gregory R.
Akhtar, Shahid
Al-Jaser, Saleh J.
Medina, Johan
Mohamed, Mafauzy
Nicodemus, Nemencio A.
Olsen, Anne Helene
Singh, Kiran P.
Kok, Adri
author_sort Fulcher, Gregory R.
collection PubMed
description INTRODUCTION: Insulin degludec/insulin aspart (IDegAsp) is a fixed-ratio co-formulation of insulin degludec (a basal insulin) and insulin aspart (a prandial insulin). The aim of this study was to investigate clinical outcomes in people with type 2 diabetes (T2D) after initiating IDegAsp treatment in a real-world setting. METHODS: This 26-week, open-label, non-interventional study was conducted in Australia, India, Malaysia, Philippines, Saudi Arabia, and South Africa. Data were obtained from 1102 adults with T2D initiating or switching to IDegAsp from antidiabetic treatments (including oral antidiabetic drugs, basal insulin, basal–bolus insulin, premix insulin, and glucagon-like peptide 1 receptor agonist) per local clinical practice. RESULTS: Compared with baseline, there was significant improvement in HbA1c at end of study (EOS, first visit within weeks 26–36; estimated change − 1.4% [95% CI − 1.51; − 1.29]; P < 0.0001 [primary outcome]). From baseline to EOS, there were significant reductions in fasting plasma glucose (− 2.7 mmol/L [95% CI − 2.98; − 2.46]; P < 0.0001), body weight (− 1.0 kg [95% CI − 1.51; − 0.52]; P < 0.0001), and basal insulin dose in insulin-experienced participants (− 2.3 units [95% CI − 3.51; − 1.01]; P < 0.001). The incidence rates of non-severe (overall and nocturnal) and severe hypoglycaemia decreased significantly (P < 0.001) between the period before baseline and before EOS. CONCLUSION: In adults with T2D, initiating or switching to IDegAsp from previous antidiabetic treatment was associated with improved glycaemic control, lower basal insulin dose (in insulin-experienced participants), and lower rates of hypoglycaemia. TRIAL REGISTRATION: Clinical trial registration NCT04042441. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-022-02212-3.
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spelling pubmed-92440592022-06-30 Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries Fulcher, Gregory R. Akhtar, Shahid Al-Jaser, Saleh J. Medina, Johan Mohamed, Mafauzy Nicodemus, Nemencio A. Olsen, Anne Helene Singh, Kiran P. Kok, Adri Adv Ther Original Research INTRODUCTION: Insulin degludec/insulin aspart (IDegAsp) is a fixed-ratio co-formulation of insulin degludec (a basal insulin) and insulin aspart (a prandial insulin). The aim of this study was to investigate clinical outcomes in people with type 2 diabetes (T2D) after initiating IDegAsp treatment in a real-world setting. METHODS: This 26-week, open-label, non-interventional study was conducted in Australia, India, Malaysia, Philippines, Saudi Arabia, and South Africa. Data were obtained from 1102 adults with T2D initiating or switching to IDegAsp from antidiabetic treatments (including oral antidiabetic drugs, basal insulin, basal–bolus insulin, premix insulin, and glucagon-like peptide 1 receptor agonist) per local clinical practice. RESULTS: Compared with baseline, there was significant improvement in HbA1c at end of study (EOS, first visit within weeks 26–36; estimated change − 1.4% [95% CI − 1.51; − 1.29]; P < 0.0001 [primary outcome]). From baseline to EOS, there were significant reductions in fasting plasma glucose (− 2.7 mmol/L [95% CI − 2.98; − 2.46]; P < 0.0001), body weight (− 1.0 kg [95% CI − 1.51; − 0.52]; P < 0.0001), and basal insulin dose in insulin-experienced participants (− 2.3 units [95% CI − 3.51; − 1.01]; P < 0.001). The incidence rates of non-severe (overall and nocturnal) and severe hypoglycaemia decreased significantly (P < 0.001) between the period before baseline and before EOS. CONCLUSION: In adults with T2D, initiating or switching to IDegAsp from previous antidiabetic treatment was associated with improved glycaemic control, lower basal insulin dose (in insulin-experienced participants), and lower rates of hypoglycaemia. TRIAL REGISTRATION: Clinical trial registration NCT04042441. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-022-02212-3. Springer Healthcare 2022-06-25 2022 /pmc/articles/PMC9244059/ /pubmed/35752730 http://dx.doi.org/10.1007/s12325-022-02212-3 Text en © The Author(s) 2022, corrected publication (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
Fulcher, Gregory R.
Akhtar, Shahid
Al-Jaser, Saleh J.
Medina, Johan
Mohamed, Mafauzy
Nicodemus, Nemencio A.
Olsen, Anne Helene
Singh, Kiran P.
Kok, Adri
Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries
title Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries
title_full Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries
title_fullStr Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries
title_full_unstemmed Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries
title_short Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries
title_sort initiating or switching to insulin degludec/insulin aspart in adults with type 2 diabetes: a real-world, prospective, non-interventional study across six countries
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9244059/
https://www.ncbi.nlm.nih.gov/pubmed/35752730
http://dx.doi.org/10.1007/s12325-022-02212-3
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