TY - JOUR
T1 - The Diabetes Unmet Need with Basal Insulin Evaluation (DUNE) study in type 2 diabetes
T2 - Achieving HbA1c targets with basal insulin in a real-world setting
AU - on behalf of the DUNE investigators
AU - Meneghini, Luigi F.
AU - Mauricio, Didac
AU - Orsi, Emanuela
AU - Lalic, Nebojsa M.
AU - Cali, Anna M.G.
AU - Westerbacka, Jukka
AU - Stella, Peter
AU - Candelas, DEA, Christophe
AU - Pilorget, Valerie
AU - Perfetti, Riccardo
AU - Khunti, Kamlesh
N1 - Funding Information:
Editorial and writing assistance was provided by Arthur Holland, PhD, of Fishawack Communications Ltd and was funded by Sanofi.
Funding Information:
The authors thank the study participants, trial staff and investigators for their participation (participating physicians are listed in Appendix S1). K. K. acknowledges support from The National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care?East Midlands (CLAHRC-EM) and the NIHR Leicester Biomedical Research Centre. Editorial and writing assistance was provided by Arthur Holland, PhD, of Fishawack Communications Ltd and was funded by Sanofi. L. M. has served on advisory panels for Novo Nordisk, Sanofi, and AstraZeneca, and has received consulting fees from Sanofi. D. M. has served on advisory panels for Sanofi, Praxis Pharmaceutical, AstraZeneca, Novo Nordisk and MSD, and has received speakers' bureau fees from Menarini, GlaxoSmithKline, Eli Lilly, Sanofi, Novartis, Novo Nordisk and MSD. E. O. has served on advisory panels for Boehringer Ingelheim and Eli Lilly, and has received speakers' bureau fees from Sanofi, Takeda, Johnson & Johnson, Novo Nordisk and AstraZeneca. N. L. has no conflicts of interest to declare. A. C., J. W., P. S., C. C., V. P. and R. P. are all employees of and stock/shareholders in Sanofi. K. K. has served on advisory panels, is a board member of, and has received consulting and speakers' bureau fees from Bayer, Novartis, Novo Nordisk, Sanofi, Eli Lilly, Servier and MSD, and has received research support from Novartis, Novo Nordisk, Sanofi, Eli Lilly, Pfizer, Boehringer Ingelheim and MSD. L. M., D. M., A. C., J. W. and K. K. were involved in study concept and design. C. C. performed the statistical analyses of data. All authors participated in the interpretation of data and in the writing, reviewing and editing of the manuscript, and all had final responsibility for approving the published version. L. M. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Funding Information:
This study was sponsored by Sanofi. Sanofi designed and coordinated the clinical trial presented in this manuscript; Sanofi; Health Research
Funding Information:
research support from Novartis, Novo Nordisk, Sanofi, Eli Lilly, Pfizer,
Publisher Copyright:
© 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
PY - 2019/6
Y1 - 2019/6
N2 - Aims: To describe in a real-world setting the achievement of physician-selected individualized HbA1c targets in individuals with type 2 diabetes, newly or recently initiated with basal insulin, and the association of hypoglycaemia with target achievement. Materials and methods: A 12-week, prospective, single-arm, observational study of adults with type 2 diabetes, either newly initiated with any basal insulin or start on basal insulin within the preceding 12 months. At enrollment, eligible participants from 28 countries were treated with or without oral antihyperglycaemic drugs and/or GLP-1 receptor agonists. Results: Individualized targets for almost all of the 3139 evaluable participants (99.7%) had been set by their physicians, with 57% of participants having HbA1c targets between 7.0% and <7.5% (53 and <58 mmol/mol). By week 12, 28% and 27% of newly and previously initiated participants, respectively, achieved individualized HbA1c targets with modest average increases in daily insulin dose of 9 and 5 U (0.10 and 0.06 U/kg), respectively, from baseline (14 and 23 U [0.17 and 0.29 U/kg], respectively). Overall, 16% of participants experienced at least one episode of hypoglycaemia. Both the incidence and frequency of hypoglycaemia, but not the severity, were positively associated with a higher likelihood of achieving individualized HbA1c targets (P < 0.05). Conclusions: In this prospective real-world study, most participants using basal insulin did not achieve the individualized HbA1c targets set by their physicians. Participants who experienced symptomatic hypoglycaemia were more likely to achieve HbA1c targets than those who did not.
AB - Aims: To describe in a real-world setting the achievement of physician-selected individualized HbA1c targets in individuals with type 2 diabetes, newly or recently initiated with basal insulin, and the association of hypoglycaemia with target achievement. Materials and methods: A 12-week, prospective, single-arm, observational study of adults with type 2 diabetes, either newly initiated with any basal insulin or start on basal insulin within the preceding 12 months. At enrollment, eligible participants from 28 countries were treated with or without oral antihyperglycaemic drugs and/or GLP-1 receptor agonists. Results: Individualized targets for almost all of the 3139 evaluable participants (99.7%) had been set by their physicians, with 57% of participants having HbA1c targets between 7.0% and <7.5% (53 and <58 mmol/mol). By week 12, 28% and 27% of newly and previously initiated participants, respectively, achieved individualized HbA1c targets with modest average increases in daily insulin dose of 9 and 5 U (0.10 and 0.06 U/kg), respectively, from baseline (14 and 23 U [0.17 and 0.29 U/kg], respectively). Overall, 16% of participants experienced at least one episode of hypoglycaemia. Both the incidence and frequency of hypoglycaemia, but not the severity, were positively associated with a higher likelihood of achieving individualized HbA1c targets (P < 0.05). Conclusions: In this prospective real-world study, most participants using basal insulin did not achieve the individualized HbA1c targets set by their physicians. Participants who experienced symptomatic hypoglycaemia were more likely to achieve HbA1c targets than those who did not.
KW - basal insulin
KW - glycaemic control
KW - hypoglycaemia
KW - insulin therapy
KW - observational study
KW - type 2 diabetes
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U2 - 10.1111/dom.13673
DO - 10.1111/dom.13673
M3 - Article
C2 - 30768845
AN - SCOPUS:85063582522
VL - 21
SP - 1429
EP - 1436
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
SN - 1462-8902
IS - 6
ER -