A controlled study of prolonged study with semi-synthetic human insulin.

Summary  Along term clinical study of semi-synthetic human monocomponent insulin (short and intermediate formulations) was undertaken in 32 patients with Type I diabetes. After a two-month run-in period, patients were randomised to either human or porcine insulin and blood glucose profiles and haemoglobin A1 were measured two monthly. Thirty-one patients (15—porcine, 16—human) have been treated for 12 months. There were no statistically significant differences between the two insulins in terms of fasting blood glucose (8.9±4.8 mmol/l porcine, 9.5±5.0 mmol/l human), haemoglobin A1 (10.4±2.6% porcine, 10.3±1.3 human), total daily dose (46.5±2.1 U porcine, 38.9±14.8 U human) or body weight (70.4±9.3 Kg porcine, 67.5±9.5 Kg human). Sera from both groups were tested for IgG binding to human and porcine insulin. In the patients treated with human insulin, binding to human insulin was 4.5±2.2μg/l at randomisation and 3.9±2.1 μg/l after six months. For the porcine group, binding to human insulin was 7.6±6.6 μg/l at randomisation and 7.8±7.2 μg/l after six months. These changes were not statistically significant. Thus no difference was found between patients treated with human or porcine insulin.