An Oral Insulin At Last? (No, not yet…)   (March 29, 2013)

Over the years, oral insulin has been a holy grail for diabetes drug companies. And like the grail, it hasn’t been found… yet. But it sounds infinitely profitable, so although swallowed insulin is rapidly inactivated in the gut, several drug companies continue their search for some way to keep swallowed insulin active.

The latest hype about oral insulin comes from a press release from a small Irish drug technology company, Merrion Pharmaceuticals, who proudly boasted that they have “successfully completed” a single-center double-blind Phase I trial of their oral insulin preparation in 83 adult male healthy volunteers.

The product they studied is a Novo-Nordisk insulin which was converted into tablets using Merrion’s patented drug delivery technology that they say will work by “improving absorption in the gastrointestinal tract of drugs that are otherwise poorly absorbed.” If the idea works, then  a  long-acting oral basal insulin would be the next blockbuster.

If it works. The study isn’t published, and no results have been announced (other than the fact the trial was successfully completed, whatever that means. I suspect it means that the investigators found the required number of volunteers, and that the volunteers completed the study, and data was collected. What the data might show is anyone’s guess.)

This seems to be the first-in-man study of this technology; I can’t locate any other trials of the product (which carries the code name NNC 0148-0000-0362 at ClinicalTrials.gov and NN1954 in some of the press releases). As the first study, it’s carefully designed to check for major safety issues (which for insulin itself are very well-known), and to gain some insight into how the stuff is absorbed, both percentage-wise, and over time, and how glucose levels were affected. Seven dose levels were studied; at each dose level, only a single dose of the stuff was given to each volunteer. Apparently only two dose-strengths were used (“1 and 3 tablets”); it’s not stated whether the 1 and the 3 represent units of insulin or something entirely different.

Publishing the results of the study would be nice, especially to see if the subjects’ glucose levels were reliably affected, and if the effect increased with increasing doses of the tablets. And no matter what the results might show, it’s going to be many years to get from this early human study to maybe someday getting approval by the FDA and other Health Authorities.