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A randomized trial of insulin aspart with intensified basal NPH insulin supplementation in people with Type 1 diabetes

Lookup NU author(s): Emeritus Professor Philip Home


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Aims: Insulin aspart has been shown to improve post-prandial and overall glycaemic control in people with Type 1 diabetes. We hypothesized that insulin aspart with intensified basal NPH insulin supplementation would result in better overall glycaemic control than human regular insulin with standard basal NPH insulin. Methods: The trial was conducted in 43 centres in seven countries. People with Type 1 diabetes were randomized to mealtime insulin aspart with up to four daily NPH doses if meals were > 5 h apart and a 25% increase in bedtime NPH dose (n = 187), or to mealtime human unmodified insulin with once or twice daily basal NPH insulin (n= 181). Efficacy and safety were evaluated at 12 weeks (primary evaluation period) and 64 weeks. Results: At 12 and 64 weeks there was no statistically significant difference in HbA1c between the insulin aspart and regular insulin groups: -0.09 (95% confidence interval (CI) -0.23, +0.05)% and -0.14 (-0.32, +0.04)%. Post-prandial glucose values were lower and the area under the 24-h self-monitored blood glucose curve above 7.0 mmol/l was 28% smaller with insulin aspart (35.2 ± 3.2 vs. 48.9 ± 3.1 mmol/l h, P = 0.0015). No significant differences were found in mild or severe hypoglycaemia, or adverse event rate. At 64 weeks treatment satisfaction was higher in the insulin aspart group (difference 1.57 (95% CI 0.49, 2.64) points, P = 0.004), while quality of life was not different. Conclusions: Improved post-prandial glycaemic control and treatment satisfaction with insulin aspart were confirmed. Intensifying basal insulin supplementation resulted in a similar HbA1c decrement as previously found with the use of insulin aspart and standard NPH insulin supplementation. This does not support routinely basal NPH insulin intensification when using rapid-acting insulin analogues in daily practice.

Publication metadata

Author(s): DeVries JH, Lindholm A, Jacobsen JL, Heine RJ, Home PD

Publication type: Article

Publication status: Published

Journal: Diabetic Medicine

Year: 2003

Volume: 20

Issue: 4

Pages: 312-318

ISSN (print): 0742-3071

ISSN (electronic): 1464-5491

Publisher: Wiley-Blackwell Publishing


DOI: 10.1046/j.1464-5491.2003.00936.x

PubMed id: 12675646


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