Insulin tablets’ safety, tolerability, exposure, and effect on blood glucose levels were tested in a clinical trial….
Novo Nordisk, in conjunction with Danish manufacturer Merrion Pharmaceuticals Plc., have tested oral insulin and successfully completed early stages trials. Currently, insulin is only available by injection for patients who do not produce enough insulin or are resistant to insulin. The insulin pill, known as NN1954, uses GIPET technology that allows them to make tablets/capsules of drugs that could only otherwise be given by injection. “GIPET uses specifically designed oral formulations of patented absorption enhancers which activate micelle formation, facilitating transport of drug and substantially increasing absorption, with good reproducibility and a strong safety profile.”
- 10 to 50 fold increase in bioavailability
- Excellent reproducibility
- GRAS status simplifies development
- Straightforward manufacturing process
Novo Nordisk completed the first of three phases of testing that included safety, tolerability, exposure, and effect on glucose levels. The trial had 83 participants from May to October 2012. The results of the trial are not available yet and are expected to be available in the future. Novo Nordisk’s oral insulin will be ground breaking technology that will give patients another option besides injection. In the future, it may enhance diabetes care and optimize blood glucose levels in patients that refuse insulin because of limited dosage forms.
Health-e-Solutions comment: An oral form of insulin, if equally safe and effective will be a much needed improvement over injectable insulin. It remains to be shown that safety and efficacy are equal to injectable insulin. We hope it is. With clinical trials still in their early phases, it will likely be some time before we know if this will be a viable adjunct treatment option. Diet and lifestyle will still be of primary importance to well-controlled blood sugars and optimal health.