Pre-meal insulin aspart compared with pre-meal soluble human insulin in type 1 diabetes

• Published in: Diabetes research and clinical practice 2006-02, Vol.71 (2), p.131-139
• Main Authors: Home, P.D., Hallgren, P., Usadel, K.H., Sane, T., Faber, J., Grill, V., Friberg, H.H.
• Format: Article
• Language: English
• Subjects: Adult; Body Mass Index; Dose-Response Relationship, Drug; Drug Administration Schedule; Eating; Female; Follow-Up Studies; Human insulin; Humans; Hypoglycaemia; Hypoglycemia - epidemiology; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - therapeutic use; Insulin - administration & dosage; Insulin - analogs & derivatives; Insulin - therapeutic use; Insulin Aspart; Insulin, Isophane - administration & dosage; Insulin, Isophane - therapeutic use; Long-term treatment; Male; Metabolic control; Middle Aged; Safety; Type 1 diabetes
• ISSN: 0168-8227; 1872-8227
• DOI: 10.1016/j.diabres.2005.05.015

Insulin aspart has been shown, in medium-term studies, to achieve reductions in HbA 1c without increasing the risk of major hypoglycaemia compared with pre-meal human insulin. The aim of the present 3-year study was to evaluate the long-term safety and efficacy of insulin aspart in people with type 1 diabetes. This was a 30-month extension of a multinational, multicentre, open-label, parallel-group study of 753 people with type 1 diabetes, originally randomly allocated to treatment with insulin aspart or unmodified human insulin before meals, with NPH insulin as basal insulin. Main outcomes measures were hypoglycaemia (major or minor), adverse events and HbA 1c. As insulin aspart became commercially available in some countries before the end of the trial, analyses of HbA 1c used 30-month data to maintain statistical power. The relative risk estimate of major hypoglycaemia was similar between treatment groups (relative risk [RR] 1.00 [95% CI 0.72, 1.39]). The risk of having a minor hypoglycaemic episode was higher with insulin aspart than with human soluble insulin (RR 1.24 [1.09, 1.39] p = 0.024). Insulin aspart was significantly superior to human insulin with respect to overall glycaemic control, with a baseline-adjusted HbA 1c difference of −0.16 (−0.32, −0.01)% ( p = 0.035). Insulin aspart was well tolerated and effective during long-term treatment. The HbA 1c advantage was maintained with insulin aspart without any adverse impact on the rate of major hypoglycaemia.