A comparison of the effects of human and animal insulin as well as of the adverse reaction profile did not show clinically relevant differences. Many patient-oriented outcomes like health-related quality of life or diabetes complications and mortality were never investigated in high-quality randomised clinical trials. The story of the introduction of human insulin might be repeated by contemporary launching campaigns to introduce pharmaceutical and technological innovations that are not backed up by sufficient proof of their advantages and safety.
A within patient cross over trial of 4 insulin regimens in antibody-negative, C-peptide negative patients.
12 patients entered a within patient cross over trial of 4 insulin regimens:--twice daily semi-synthetic human soluble and insulin zinc suspension (Actrapid/Monotard HM), twice daily porcine soluble and insulin zinc suspension (Actrapid/Monotard), twice daily porcine soluble and isophane insulin (Velosulin/Insulatard), and thrice daily porcine soluble insulin (Actrapid) supplementing once daily bovine ultralente insulin (Ultratard). Each insulin regimen lasted 10 weeks, the order of allocation being determined on a random basis. Patients were encouraged to improve glycaemic control throughout the study by self adjustment of insulin dosage guided by standard algorithms. Metabolic control was assessed by capillary blood glucose series, M-values, HbA1c, and fasting lipids. No significant differences in M-values, mean HbA1c or fasting lipids were found at the end of any of the regimens. Patients achieved significantly (p less than 0.01) lower pre-lunch blood glucose on Velosulin/Insulatard than on any other regimen, but severe hypoglycaemic events were more common (p less than 0.05) on this regimen. A significant fall in HbA1c values from that at recruitment could be demonstrated only by analysing treatment periods in chronological order. Thus at the end of the second study period, mean HbA1c was significantly less than that at recruitment (p less than 0.01), but by the end of the 4 treatment periods of our study, had returned to levels similar to those at recruitment. Similar control is achieved on semi-synthetic human insulin as on other conventional regimens. Day-to-day variability of blood glucose, expressed as a standard deviation, is approximately twice the maximum difference between any 2 regimens at any time point.(ABSTRACT TRUNCATED AT 250 WORDS)