TRANSFERENCE OF INSULIN IN 198 PATIENTS O F 6 LATINAMERICAN COUNTRIES

A multicentric, comparative, single-blind, randomized, prospective stu dy was designed to evaluate the efficacy and safety of the transferenc e from animal source insulins to rDNA human insulin in Latinamerican i nsulin-requiring diabetic patients. All the patients were on animal in sulin for at least two months before inclusion. The patients were eval uated at the beginning, and at two and six weeks after inclusion. A to tal 198 patients completed the study and were considered evaluable: 94 were assigned to the animal insulin group, and 104 to the human insul in group. There were no statistically significant baseline differences between groups. The only statistically significant difference, detect ed at the end of the study, was a reduction in fasting blood glucose l evel in the human insulin group (animal insulin 212 +/- 95.3 initial v s 193 +/- 78.3 mg/dL final, p=0.18; human insulin 198 +/- 86.8 vs 169 +/- 71.7, p=0.025). There were no statistically significant initial-fi nal changes in the rest of the parameters evaluated although a trend o f reduction in glycohemoglobin levels was observed in both groups. The re were more episodes of mild hipoglycemia in the human insulin group, and only one episode of severe unwarned hypoglycemia in the same grou p. We conclude that the transference of insulins in Latinamerican diab etic patients is effective and reasonably safe (with a dose adjustment when the change is made).