Comparison of conventional twice daily subcutaneous insulin administration and a multiple injection regimen (using the NovoPen) in insulin-dependent diabetes mellitus.

Thirty-seven stable insulin-dependent diabetic patients receiving twice daily premixed porcine soluble and isophane insulins (Mixtard or Initard, Nordisk Laboratories) were enrolled in a trial to compare the effects of this regimen and an intensified regimen on glycaemic control and flexibility of lifestyle. After a two month run-in period patients were randomized to continue taking premixed insulin (n = 18) or to change to Human Actrapid (three times daily pre-prandial doses using a NovoPen) plus Human Ultratard (n = 19: "pen" group, Novo Laboratories). Diabetic control was assessed at monthly intervals for six months by glycosylated haemoglobin assay (HbA1), 7-point blood glucose profiles and frequency of hypoglycaemic episodes. At randomization, glycaemic control had significantly improved in the group as a whole and patients were well matched with respect to body mass index (BMI) and glycaemic control. No significant changes in BMI, HbA1, mean 7-point glucose profiles or hypoglycaemic episodes were found after six months either within or between groups. Hypoglycaemic episodes were common during the study. There were no technical problems with the NovoPen. Patients using the NovoPen felt it added greater flexibility to their lifestyle. From our study results the main indication to start a multiple injection regimen is to improve the flexibility of the patient's lifestyle and not to improve glycaemic control.