Clinical Studies of Insulin-replacement Therapy

Other major points of interest in clinical trials are hyperinsulinaemia and insulin resistance as a common denominator of the metabolic syndrome, hyperinsulinaemia as an independent predictor of coronary heart disease, and the efficacy of new insulin analogues. 

Pulsatile insulin is more effective in suppressing hepatic glucose production while it exhibits an equipotent effect on glucose utilization (Bratusch-Marrain et al., 1986). The application of pulsatile insulin may thus reduce free insulin levels (Waldhausl et al., 1985) and insulin resistance and may contribute more effectively to a reduction in hormone load in insulin-treated diabetic patients. 

Clinical trials on the effects of long-acting insulin analogues showed only a small intraindividual variation of absorption from the injection site with an 

A prolonged insulin action can also be achieved by encapsulation of insulin in liposomes before subcutaneous injection. The extended hypoglycaemic response is believed to be a result of a lower metabolic clearance rate. Currently, the encapsulation efficiency, however, is only 5% (Spangler, 1990). Further investigations are needed. 

Conventional insulin treatment with its fixed insulin dosage and food intake has dominated therapy of insulin-dependent diabetes mellitus for nearly 70 years. It has sharply reduced the mortality of diabetic coma. Nevertheless diabetic coma is still the largest single cause of death in diabetic patients under the age of 20 years with an episode rate of 7%, and diabetic coma accounts for 15% of deaths in diabetics under the age of 50 years. 

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