X14 is an analogue of human insulin in which the amino acid proline has been replaced by the amino acid aspartic acid. This change reduces the tendency of the insulin molecules to self associate, thereby reducing the time of onset and the duration of action once the insulin is injected subcutaneously. The primary objective of this trial is to compare the effect of Human Insulin Analogue X14 with the effect of Regular Human Insulin on glycemic control as measured by Hemoglobin A1c. The trial will also evaluate the results of several 8-point blood glucose profiles and the number of hypoglycemic episodes over 6 months. A safety profile of Human Insulin Analogue X14 will be compiled based on the number of adverse events reported and the results of routine hematology, chemistry, lipid and antibody testing.
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