Bowering, K. orcid.org/0000-0002-0075-0624, Rodbard, H.W., Russell-Jones, D. et al. (8 more authors) (2019) Investigating the association between baseline characteristics (HbA1c and Body Mass Index) and clinical outcomes of fast-acting insulin aspart in people with diabetes: a post hoc analysis. Diabetes Therapy, 10 (1). pp. 177-188. ISSN 1869-6953
Abstract
Introduction: The aim of this study was to investigate the association between baseline characteristics [HbA1c and body mass index (BMI)] and the effect of mealtime fast-acting insulin aspart (faster aspart) relative to insulin aspart (IAsp) or basal-only insulin therapy on several efficacy and safety outcomes in people with diabetes.
Methods: Post hoc analysis of three randomised phase 3a trials in people with type 1 diabetes (T1D; onset 1) and type 2 diabetes (T2D; onset 2 and 3). Participants (N = 1686) were stratified according to baseline BMI (< 25 kg/m 2 , 25–< 30 kg/m 2 , ≥ 30 kg/m 2 ) or HbA1c (≤ 58 mmol/mol, > 58–< 64 mmol/mol, ≥ 64 mmol/mol; ≤ 7.5%, > 7.5–< 8.0%, ≥ 8.0%).
Results: In participants with T2D, the estimated treatment difference for change in HbA1c was similar for all BMI and HbA1c subgroups. No major differences between treatments were observed in risk of overall hypoglycaemia or insulin dose across subgroups. In participants with T1D, change in HbA1c was similar across BMI and HbA1c subgroups, and no major differences between treatments were observed for severe or blood glucose-confirmed hypoglycaemia across subgroups. Total daily insulin dose (U/kg) was similar across all baseline HbA1c groups and the BMI < 25 kg/m 2 and 25–30 kg/m 2 groups, but was significantly lower with mealtime faster aspart compared with IAsp in the BMI > 30 kg/m 2 subgroup.
Conclusions: In participants with T1D and T2D, treatment differences (for change in HbA1c and overall hypoglycaemia) between mealtime faster aspart and insulin comparators were similar to the corresponding overall analysis across baseline HbA1c and BMI subgroups. The finding of a lower total daily insulin dose in participants with obesity (BMI > 30 kg/m 2 ) and T1D treated with faster aspart, versus those treated with IAsp, may warrant further investigation.
Trial Registration: ClinicalTrials.gov NCT01831765 (onset 1); NCT01819129 (onset 2); NCT01850615 (onset 3).
Funding: Novo Nordisk A/S, Søborg, Denmark.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © The Author(s) 2018. This 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/. |
Keywords: | Diabetes mellitus, type 1; Diabetes mellitus, type 2; Haemoglobin A, glycosylated; Index, body mass; Insulin aspart; Outcome, treatment |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > The Medical School (Sheffield) > Division of Genomic Medicine (Sheffield) > Department of Oncology and Metabolism (Sheffield) The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Medicine and Population Health |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 29 Aug 2024 13:23 |
Last Modified: | 29 Aug 2024 13:23 |
Status: | Published |
Publisher: | Springer Science and Business Media LLC |
Refereed: | Yes |
Identification Number: | 10.1007/s13300-018-0553-7 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:216516 |