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Improved health status with insulin degludec compared with insulin glargine in people with Type 1 diabetes

AIMS: The efficacy and safety of insulin degludec (degludec), a new-generation ultra-long-acting basal insulin, was compared with insulin glargine (glargine) in people with Type 1 diabetes mellitus in a 16-week, open-label, randomized trial. Health status, an important aspect of effective diabetes m...

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Autores principales: Home, P D, Meneghini, L, Wendisch, U, Ratner, R E, Johansen, T, Christensen, T E, Jendle, J, Roberts, A P, Birkeland, K I
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3397676/
https://www.ncbi.nlm.nih.gov/pubmed/22150786
http://dx.doi.org/10.1111/j.1464-5491.2011.03547.x
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author Home, P D
Meneghini, L
Wendisch, U
Ratner, R E
Johansen, T
Christensen, T E
Jendle, J
Roberts, A P
Birkeland, K I
author_facet Home, P D
Meneghini, L
Wendisch, U
Ratner, R E
Johansen, T
Christensen, T E
Jendle, J
Roberts, A P
Birkeland, K I
author_sort Home, P D
collection PubMed
description AIMS: The efficacy and safety of insulin degludec (degludec), a new-generation ultra-long-acting basal insulin, was compared with insulin glargine (glargine) in people with Type 1 diabetes mellitus in a 16-week, open-label, randomized trial. Health status, an important aspect of effective diabetes management, was also assessed. METHODS: Degludec (n = 59) or glargine (n = 59) were injected once daily, with insulin aspart at mealtimes. Health status assessment utilized the validated Short Form 36 Health Survey, version 2, which has two summary component scores for mental and physical well-being, each comprising four domains. RESULTS: At study end, HbA(1c) reductions were comparable between groups, but confirmed nocturnal hypoglycaemia was significantly less frequent with degludec [relative rate 0.42 (95% CI 0.25–0.69)], and overall hypoglycaemia numerically less frequent [relative rate 0.72 (95% CI 0.52–1.00)]. After 16 weeks, a significant improvement in Short Form 36 Health Survey mental component score of +3.01 (95% CI 0.32–5.70) was obtained for degludec against glargine, attributable to significant differences in the social functioning [+8.04 (95% CI 1.89–14.18)] and mental health domains [+2.46 (95% CI 0.10–4.82)]. For mental component score, Cohen’s effect size was 0.42, indicating a small-to-medium clinically meaningful difference. The physical component score [+0.66 (95% CI –2.30 to 3.62)] and remaining domains were not significantly different between degludec and glargine. CONCLUSIONS: In the context of comparable overall glycaemic control with glargine, degludec improved mental well-being as measured using the mental component score of the Short Form 36 Health Survey. The improvements in overall mental component score and the underlying social functioning and mental health domains with degludec compared with glargine may relate to the observed reduction in hypoglycaemic events.
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spelling pubmed-33976762012-07-17 Improved health status with insulin degludec compared with insulin glargine in people with Type 1 diabetes Home, P D Meneghini, L Wendisch, U Ratner, R E Johansen, T Christensen, T E Jendle, J Roberts, A P Birkeland, K I Diabet Med Original Articles AIMS: The efficacy and safety of insulin degludec (degludec), a new-generation ultra-long-acting basal insulin, was compared with insulin glargine (glargine) in people with Type 1 diabetes mellitus in a 16-week, open-label, randomized trial. Health status, an important aspect of effective diabetes management, was also assessed. METHODS: Degludec (n = 59) or glargine (n = 59) were injected once daily, with insulin aspart at mealtimes. Health status assessment utilized the validated Short Form 36 Health Survey, version 2, which has two summary component scores for mental and physical well-being, each comprising four domains. RESULTS: At study end, HbA(1c) reductions were comparable between groups, but confirmed nocturnal hypoglycaemia was significantly less frequent with degludec [relative rate 0.42 (95% CI 0.25–0.69)], and overall hypoglycaemia numerically less frequent [relative rate 0.72 (95% CI 0.52–1.00)]. After 16 weeks, a significant improvement in Short Form 36 Health Survey mental component score of +3.01 (95% CI 0.32–5.70) was obtained for degludec against glargine, attributable to significant differences in the social functioning [+8.04 (95% CI 1.89–14.18)] and mental health domains [+2.46 (95% CI 0.10–4.82)]. For mental component score, Cohen’s effect size was 0.42, indicating a small-to-medium clinically meaningful difference. The physical component score [+0.66 (95% CI –2.30 to 3.62)] and remaining domains were not significantly different between degludec and glargine. CONCLUSIONS: In the context of comparable overall glycaemic control with glargine, degludec improved mental well-being as measured using the mental component score of the Short Form 36 Health Survey. The improvements in overall mental component score and the underlying social functioning and mental health domains with degludec compared with glargine may relate to the observed reduction in hypoglycaemic events. Blackwell Publishing Ltd 2012-06 /pmc/articles/PMC3397676/ /pubmed/22150786 http://dx.doi.org/10.1111/j.1464-5491.2011.03547.x Text en © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK http://creativecommons.org/licenses/by/2.5/ Re-use of this article is permitted in accordance with the Terms and Conditions set out at http://wileyonlinelibrary.com/onlineopen#OnlineOpen_Terms
spellingShingle Original Articles
Home, P D
Meneghini, L
Wendisch, U
Ratner, R E
Johansen, T
Christensen, T E
Jendle, J
Roberts, A P
Birkeland, K I
Improved health status with insulin degludec compared with insulin glargine in people with Type 1 diabetes
title Improved health status with insulin degludec compared with insulin glargine in people with Type 1 diabetes
title_full Improved health status with insulin degludec compared with insulin glargine in people with Type 1 diabetes
title_fullStr Improved health status with insulin degludec compared with insulin glargine in people with Type 1 diabetes
title_full_unstemmed Improved health status with insulin degludec compared with insulin glargine in people with Type 1 diabetes
title_short Improved health status with insulin degludec compared with insulin glargine in people with Type 1 diabetes
title_sort improved health status with insulin degludec compared with insulin glargine in people with type 1 diabetes
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3397676/
https://www.ncbi.nlm.nih.gov/pubmed/22150786
http://dx.doi.org/10.1111/j.1464-5491.2011.03547.x
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