Improved health status with insulin degludec compared with insulin glargine in people with Type1 diabetes

P. D. Home, L. Meneghini, U. Wendisch, R. E. Ratner, T. Johansen, T. E. Christensen, J. Jendle, A. P. Roberts, K. I. Birkeland

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

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 Type1 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 Form36 Health Survey, version2, 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 rate0.42 (95%CI 0.25-0.69)], and overall hypoglycaemia numerically less frequent [relative rate0.72 (95%CI 0.52-1.00)]. After 16weeks, a significant improvement in Short Form36 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 Form36 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.

Original languageEnglish (US)
Pages (from-to)716-720
Number of pages5
JournalDiabetic Medicine
Volume29
Issue number6
DOIs
StatePublished - Jun 2012

Fingerprint

Health Status
Health Surveys
Hypoglycemia
Mental Health
Insulin Aspart
Long-Acting Insulin
insulin degludec
Insulin Glargine
Hypoglycemic Agents
Meals
Diabetes Mellitus
Safety

Keywords

  • Hypoglycaemia
  • Insulin
  • Insulin therapy
  • Quality of life
  • Type1 diabetes

ASJC Scopus subject areas

  • Endocrinology
  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Home, P. D., Meneghini, L., Wendisch, U., Ratner, R. E., Johansen, T., Christensen, T. E., ... Birkeland, K. I. (2012). Improved health status with insulin degludec compared with insulin glargine in people with Type1 diabetes. Diabetic Medicine, 29(6), 716-720. https://doi.org/10.1111/j.1464-5491.2011.03547.x

Improved health status with insulin degludec compared with insulin glargine in people with Type1 diabetes. / Home, P. D.; Meneghini, L.; Wendisch, U.; Ratner, R. E.; Johansen, T.; Christensen, T. E.; Jendle, J.; Roberts, A. P.; Birkeland, K. I.

In: Diabetic Medicine, Vol. 29, No. 6, 06.2012, p. 716-720.

Research output: Contribution to journalArticle

Home, PD, Meneghini, L, Wendisch, U, Ratner, RE, Johansen, T, Christensen, TE, Jendle, J, Roberts, AP & Birkeland, KI 2012, 'Improved health status with insulin degludec compared with insulin glargine in people with Type1 diabetes', Diabetic Medicine, vol. 29, no. 6, pp. 716-720. https://doi.org/10.1111/j.1464-5491.2011.03547.x
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 Type1 diabetes. In: Diabetic Medicine. 2012 ; Vol. 29, No. 6. pp. 716-720.
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abstract = "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 Type1 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 Form36 Health Survey, version2, 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 rate0.42 (95{\%}CI 0.25-0.69)], and overall hypoglycaemia numerically less frequent [relative rate0.72 (95{\%}CI 0.52-1.00)]. After 16weeks, a significant improvement in Short Form36 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 Form36 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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AU - Meneghini, L.

AU - Wendisch, U.

AU - Ratner, R. E.

AU - Johansen, T.

AU - Christensen, T. E.

AU - Jendle, J.

AU - Roberts, A. P.

AU - Birkeland, K. I.

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N2 - 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 Type1 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 Form36 Health Survey, version2, 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 rate0.42 (95%CI 0.25-0.69)], and overall hypoglycaemia numerically less frequent [relative rate0.72 (95%CI 0.52-1.00)]. After 16weeks, a significant improvement in Short Form36 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 Form36 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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KW - Hypoglycaemia

KW - Insulin

KW - Insulin therapy

KW - Quality of life

KW - Type1 diabetes

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