@article{c63c0646a2ff4893acf4a61fe06a6b63,
title = "Switching to Degludec is Associated with Reduced Hypoglycaemia, Irrespective of Definition Used or Patient Characteristics: Secondary Analysis of the ReFLeCT Prospective, Observational Study",
abstract = "Introduction: Hypoglycaemia is a common side effect of insulin therapy; low or high glycated haemoglobin (HbA1c) levels, history of hypoglycaemia or long diabetes duration are known modifiers of hypoglycaemia risk. In randomised clinical trials, lower rates of hypoglycaemia have been observed with the new-generation insulin analogue, long-acting insulin degludec, compared with other basal insulins. Methods: The ReFLeCT study was a prospective observational study over 12 months. Patient-reported diary data on hypoglycaemia were collected from patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) who were switching from other basal insulins to insulin degludec (degludec) at their physician{\textquoteright}s discretion in routine clinical care. Two secondary analyses were undertaken to investigate the change in number of hypoglycaemic events: a post hoc analysis using the updated American Diabetes Association (ADA) level 1, 2 and 3 hypoglycaemia definitions, and a pre-specified analysis using patient characteristics (baseline HbA1c, diabetes duration, and physician{\textquoteright}s rationale for initiating degludec). Results: Switching to degludec was associated with significantly fewer hypoglycaemic events for all definitions in T1D, and level 1 and 2 in T2D (too few level 3 events for statistical comparison). Moreover, patient characteristics did not influence the observed reduction in hypoglycaemia in T1D and T2D. Conclusion: These results demonstrate that switching to degludec from other basal insulins was associated with reduced rates of hypoglycaemia, irrespective of the definition used or baseline patient characteristics. Trial Registration: NCT02392117.",
keywords = "Basal insulin, Hypoglycaemia, Insulin degludec, Type 1 diabetes, Type 2 diabetes, Type 2 diabetes, Type 1 diabetes",
author = "\{de Valk\}, \{Harold W.\} and Michael Feher and Hansen, \{Troels Krarup\} and Johan Jendle and Koefoed, \{Mette Marie\} and Rizi, \{Ehsan Parvaresh\} and Esther Zimmermann and Fadini, \{Gian Paolo\}",
note = "Funding Information: This manuscript and the journal{\textquoteright}s Rapid Service Fee were funded by Novo Nordisk A/S, S{\o}borg, Denmark. Funding Information: The authors thank Jo{\~a}o Diogo Da Rocha Fernandes (Novo Nordisk A/S, S{\o}borg, Denmark) for his review of and input to the manuscript. The authors thank the participants of the study. This manuscript and the journal{\textquoteright}s Rapid Service Fee were funded by Novo Nordisk A/S, S{\o}borg, Denmark. The authors thank Alice Singleton, Chloe Harrison and Beverly La Ferla from Watermeadow Medical, an Ashfield Company (sponsored by Novo Nordisk) for providing medical writing and editorial support. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. These data were previously presented at the ADA 79th Scientific Sessions, June 07–11 2019, San Francisco, California, USA, and at the 55th EASD Annual Meeting, September 16–20 2019, Barcelona, Spain. Gian Paolo Fadini received grant support, lecture fees or advisory board fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Sanofi, Genzyme, Abbott, Novartis and Merck Sharp \& Dohme. Michael Feher received financial support for research, speaker meetings and consultancy from Amgen, AstraZeneca, Novo Nordisk, Eli Lilly and Sanofi-Aventis. Michael Feher was affiliated with the University of Surrey, Guildford, UK at the time of study and is now affiliated with Nuffield Department of Primary Care Health Sciences, University of Oxford, UK. Michael Feher is still affiliated with Beta Cell Diabetes Centre, Chelsea and Westminster Hospital, London, UK. Troels Krarup Hansen and Harold W. de Valk have nothing to disclose. Esther Zimmermann and Mette Marie Koefoed are full-time employees of, and hold stock in, Novo Nordisk A/S. Ehsan Parvaresh Rizi is a full-time employee of Novo Nordisk A/S. Johan Jendle has contributed to advisory boards for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Medtronic, Novo Nordisk and Sanofi, as well as chairing meetings/lectures for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Nordic Infucare, Novo Nordisk and Sanofi. Informed consent was obtained from all patients, in accordance with the requirements of the Declaration of Helsinki, before any study-related activities. Independent ethics committees and institutional review boards across the participating centres reviewed and approved this study (Supplementary Table S1). The datasets analysed during the current study are available from the corresponding author on reasonable request. Funding Information: Gian Paolo Fadini received grant support, lecture fees or advisory board fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Sanofi, Genzyme, Abbott, Novartis and Merck Sharp \& Dohme. Michael Feher received financial support for research, speaker meetings and consultancy from Amgen, AstraZeneca, Novo Nordisk, Eli Lilly and Sanofi-Aventis. Michael Feher was affiliated with the University of Surrey, Guildford, UK at the time of study and is now affiliated with Nuffield Department of Primary Care Health Sciences, University of Oxford, UK. Michael Feher is still affiliated with Beta Cell Diabetes Centre, Chelsea and Westminster Hospital, London, UK. Troels Krarup Hansen and Harold W. de Valk have nothing to disclose. Esther Zimmermann and Mette Marie Koefoed are full-time employees of, and hold stock in, Novo Nordisk A/S. Ehsan Parvaresh Rizi is a full-time employee of Novo Nordisk A/S. Johan Jendle has contributed to advisory boards for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Medtronic, Novo Nordisk and Sanofi, as well as chairing meetings/lectures for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Nordic Infucare, Novo Nordisk and Sanofi. Publisher Copyright: {\textcopyright} 2020, The Author(s).",
year = "2020",
month = sep,
day = "1",
doi = "10.1007/s13300-020-00875-1",
language = "English",
volume = "11",
pages = "2159--2167",
journal = "Diabetes Therapy",
issn = "1869-6961",
publisher = "Springer Publishing Company",
number = "9",
}