Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial

Authors

  • P. D. Home,

    1. *Human Diabetes and Metabolism Research Centre, University of Newcastle upon Tyne, UK †Novo Nordisk A/S, Bagsvaerd, Denmark ‡See Appendix for full list of investigators
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  • A. Lindholm,

    1. *Human Diabetes and Metabolism Research Centre, University of Newcastle upon Tyne, UK †Novo Nordisk A/S, Bagsvaerd, Denmark ‡See Appendix for full list of investigators
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  • A. Riis,

    1. *Human Diabetes and Metabolism Research Centre, University of Newcastle upon Tyne, UK †Novo Nordisk A/S, Bagsvaerd, Denmark ‡See Appendix for full list of investigators
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  • for the European Insulin Aspart Study Group

    1. *Human Diabetes and Metabolism Research Centre, University of Newcastle upon Tyne, UK †Novo Nordisk A/S, Bagsvaerd, Denmark ‡See Appendix for full list of investigators
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Professor Philip Home, Department of Medicine, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.. E-mail: philip.home@newcastle.ac.uk

Abstract

SUMMARY

Aims  To compare the efficacy of insulin aspart, a rapid-acting insulin analogue, with that of unmodified human insulin on long-term blood glucose control in Type 1 diabetes mellitus.

Methods  Prospective, multi-centre, randomized, open-labelled, parallel-group trial lasting 6 months in 88 centres in eight European countries and including 1070 adult subjects with Type 1 diabetes. Study patients were randomized 2:1 to insulin aspart or unmodified human insulin before main meals, with NPH-insulin as basal insulin. Main outcome measures were blood glucose control as assessed by HbA1c, eight-point self-monitored blood glucose profiles, insulin dose, quality of life, hypoglycaemia, and adverse events.

Results  After 6 months, insulin aspart was superior to human insulin with respect to HbA1c with a baseline-adjusted difference in HbA1c of 0.12 (95% confidence interval 0.03–0.22) %Hb, P < 0.02. Eight-point blood glucose profiles showed lower post-prandial glucose levels (mean baseline-adjusted −0.6 to −1.2 mmol/l, P < 0.01) after all main meals, but higher pre-prandial glucose levels before breakfast and dinner (0.7–0.8 mmol/l, P < 0.01) with insulin aspart. Satisfaction with treatment was significantly better in patients treated with insulin aspart (WHO Diabetes Treatment Satisfaction Questionnaire (DTSQ) baseline-adjusted difference 2.3 (1.2–3.3) points, P < 0.001). The relative risk of experiencing a major hypoglycaemic episode with insulin aspart compared to human insulin was 0.83 (0.59–1.18, NS). Major night hypoglycaemic events requiring parenteral treatment were less with insulin aspart (1.3 vs. 3.4% of patients, P < 0.05), as were late post-prandial (4–6 h) events (1.8 vs. 5.0% of patients, P < 0.005).

Conclusions  These results show small but useful advantage for the rapid-acting insulin analogue insulin aspart as a tool to improve long-term blood glucose control, hypoglycaemia, and quality of life, in people with Type 1 diabetes mellitus.

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