First-Ever Randomized Trial Shows Oral Insulin Feasibility

Oral insulin isn’t available just yet, but proof of its feasibility has now been published for the first time, with the results of a randomized, controlled clinical trial in patients with type 2 diabetes.

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.