Oral insulin feasibility trial research was just published


These are promising results: It’s really too bad that Novo discontinued this research:

From the article:

Findings from the phase 2 trial of Novo Nordisk’s investigational — and now discontinued — long-acting oral basal insulin “I338” were published onlineJanuary 21 in Lancet Diabetes & Endocrinology by Inge B. Halberg, PhD, of the company, and colleagues.

The product was formulated in a tablet with the absorption enhancer sodium caprate to make it less susceptible to degradation in the gastrointestinal tract. Sodium caprate is the sodium salt of the fatty acid caprate, which is approved as a food additive and considered safe by the US Food and Drug Administration.

In the study, which involved 50 insulin-naive patients with type 2 diabetes, oral I338 reduced fasting plasma glucose (FPG) at 8 weeks — similarly to injected insulin glargine — with no significant differences in adverse events. Novo Nordisk is no longer pursuing the I338 formulation because the effective doses were too high and production required quantities deemed not commercially viable.

And the published journal article:


Pity, really. Here is the conclusion (trial of 50 patients):

I338 can safely improve glycaemic control in insulin-naive patients with type 2 diabetes with no evidence of a difference compared with insulin glargine, a widely used subcutaneously administered basal insulin.


Further development of this particular oral insulin project was discontinued because I338 doses were high and, therefore, production of the required quantities of I338 for wide public use was deemed not commercially viable. Improvement of technologies involved in the product’s development is the focus of ongoing research.