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A randomized trial of insulin aspart with intensified basal NPH insulin supplementation in people with Type 1 diabetes.
- Source :
-
Diabetic medicine : a journal of the British Diabetic Association [Diabet Med] 2003 Apr; Vol. 20 (4), pp. 312-8. - Publication Year :
- 2003
-
Abstract
- 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.<br />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.<br />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.<br />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.
Details
- Language :
- English
- ISSN :
- 0742-3071
- Volume :
- 20
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Diabetic medicine : a journal of the British Diabetic Association
- Publication Type :
- Academic Journal
- Accession number :
- 12675646
- Full Text :
- https://doi.org/10.1046/j.1464-5491.2003.00936.x