Symptomatic and counterregulatory hormonal responses to acute hypoglycaemia induced by insulin aspart and soluble human insulin in Type 1 diabetes

Background The aim of this study was to assess hypoglycaemia awareness with the insulin analogue, insulin aspart. The counterregulatory hormonal and s ymptomatic responses to hypoglycaemia induced by insulin aspart were compar ed with soluble human insulin in a double-blind, randomised, two-period cro ssover trial in patients with Type 1 diabetes. The primary objective was to compare the blood glucose threshold for autonomic activation during hypogl ycaemia induced by insulin aspart: and soluble human insulin. Secondary obj ectives were to compare the counterregulatory, symptomatic and physioIogica l responses to hypoglycaemia. Methods 20 patients were screened, 17 were randomised and 16 completed the study. Acute hypoglycaemia was induced by intravenous infusion of insulin a spart or soluble human insulin (100 U ml(-1) at a rate of 2 mU kg(-1) min(- 1)). Results No statistical difference between insulin aspart and soluble human insulin was shown for the primary blood glucose endpoint; mean arterialised blood glucose concentrations (+/-SD) at the onset of autonomic activation were 1.88 +/- 0.39 mmol L-1 for insulin aspart and 1.89 +/- 0.43 mmol L-1 f or soluble human insulin (not significant). No statistical differences were observed between the two insulins for the secondary endpoints: counter-reg ulatory hormonal responses, autonomic responses, hypoglycaemia symptom scor es, cognitive function and blood glucose responses. No serious adverse even ts were reported during the study. Conclusions Insulin aspart and soluble human insulin elicit the same counte rregulatory and symptomatic responses to acute hypoglycaemia in patients wi th Type 1 diabetes. Copyright (C) 2000 John Wiley & Sons, Ltd.