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

Lookup NU author(s): Emeritus Professor Philip Home

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Abstract

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 HbA(1c), 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 HbA(1c) with a baseline-adjusted difference in HbA(1c) 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 postprandial (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.

Publication metadata

Author(s): Home PD, Lindholm A, Riis A

Publication type: Article

Publication status: Published

Journal: Diabetic Medicine

Year: 2000

Volume: 17

Issue: 11

Pages: 762-770

ISSN (print): 0742-3071

ISSN (electronic): 1464-5491

Publisher: Wiley-Blackwell Publishing Ltd.

URL: http://dx.doi.org/10.1046/j.1464-5491.2000.00380.x

DOI: 10.1046/j.1464-5491.2000.00380.x

PubMed id: 11131100

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