Cortecs International has released its preliminary findings on the clinical development of an oral formulation of insulin for the management of diabetes mellitus. At present the peptide insulin must be injected into the body.
The first Phase I trial involving six patients, is a placebo-controlled, cross-over trial. The fasting healthy volunteers were dosed with an oral insulin formulation via a tube into the small intestine in order to replicate the findings noted in pigs. At a dose of 200 international units, plasma insulin levels were higher than those observed in patients administered placebo.
The next stage of the trial will use the same model, but will test subjects after a glucose load in an effort to optimize conditions. Following this, tablet formulations will be utilized to study the efficacy of this delivery system, and if a positive outcome is observed then single-dose studies will be performed on the patients.
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