Clinical evaluation of oral insulin formulation in type-2 diabetic patients

Abstract EN

The objective of this study was to assess the clinical efficacy of a single dose of insulin (100 IU) incorporated with a group of additives in enteric-coated, chitosan-coated capsules through its glucose lowering effect over a period of 12 hours.

The capsules were administered orally to type-2 diabetic patients.

The results were compared to those of oral administration of capsules of the same coating containing only insulin (100 IU) without additives, S.C.

insulin injection (average dose 18 IU) and oral placebo.

Ten patients with type-2 diabetes were enrolled in this blind, placebo-controlled, four-way crossover study.

It was found that, capsules containing only insulin resulted in a slight decrease in the mean blood glucose levels of the 10 patients compared to control especially in the period from 6 to 12 hours following administration.

On the other hand, capsules containing insulin with additives showed a remarkable lowering of the blood glucose levels.

Their effect started 3 hours following administration and sustained to the end of the experiment (12 h).

During the first 4 hours following administration was the reduction resulting from S.C.

insulin was significantly higher than that produced by capsules containing insulin with additives.

In the period from 4-7 hours, the effect of the capsules was comparable to that of S.C.

insulin (no significant difference).

Beyond that (7-12 hours), there was a highly significant difference in favor of capsules.

The relative bioavailability obtained by capsules containing only insulin was 3.43%, while that obtained by capsules containing insulin with additives was 18.54 %.