Novo Nordisk Starts Phase 1 Trial With Oral Insulin

Novo Nordisk announced today that it has initiated its first phase 1 clinical trial with an oral insulin analogue (NN1952). The aim of the trial, conducted in Germany, is to investigate the safety, tolerance, exposure of drug and effect of NN1952 oral insulin in healthy volunteers and people with type 1 and type 2 diabetes.
Results from the trial, which plans to enroll about 80 people, are expected to be reported in the first half of 2011.

There are many challenges with the development and production of a reliable insulin formulation for oral use. They include avoiding enzymatic degradation in the gastrointestinal tract, overcoming poor spontaneous insulin permeability over the intestinal wall, limiting variability of absorption (caused, for example, by interaction with food), and producing insulin in sufficient scale cost – effectively.

NN1952 has been designed to address some of the key challenges relating to oral insulin delivery. Furthermore, it utilizes the GIPET® formulation technology from Merrion Pharmaceuticals to facilitate insulin absorption from the gut.
In November 2008, Merrion entered into a development and license agreement to develop and commercialize oral formulations of Novo Nordisk’s proprietary insulin analogues, using Merrion’s proprietary GIPET® technology (Gastrointestinal Permeation Enhancement Technology).