Denmark-based Novo Nordisk A/S has begun phase 1 testing of an insulin pill that, if successful, could replace injections as the primary means of blood sugar control for millions of people with type 1 and type 2 diabetes. The company has enrolled 80 volunteer German test subjects in the study and expects to have preliminary results by the first half of 2011. The test group consists of both people with diabetes and people without it.
The quest to find a way to deliver insulin without the pain and inconvenience of needles, pens, and pumps is a long one. Novo’s experiment comes almost three years after Pfizer, Inc., withdrew Exubera, an inhaled insulin, from the market after it failed to build a following with patients or healthcare professionals.
Any method that involves administering insulin orally must overcome the ill effects of saliva and digestive juices on insulin’s relatively delicate molecular structure. The problem is keeping the hormone intact until it can get far enough into the system to enter the bloodstream. Novo’s approach uses a patented drug delivery system called gastrointestinal permeation enhancement technology (GIPET), which helps the gut absorb insulin.
Developed by Novo’s Ireland-based R&D partner, Merrion Pharmaceuticals, GIPET works by adding patented absorption enhancers to a heavily coated pill containing insulin. After the pill is ingested, the coating protects it until it can reach the duodenum, the first section of the small intestine, just past the stomach. There, as the pill begins to dissolve, the absorption enhancers quicken the passage of the drug across the duodenal cell membrane and into the bloodstream.
In 20 clinical studies across a range of drugs, GIPET increased oral drug absorption up to 46 times in some cases. Novo’s test will investigate the drug delivery’s safety and effectiveness, as well as test subjects’ tolerance to insulin delivered in oral form.
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