Cortecs International of the UK has released updated information regarding the status of the company's clinical trials.
The second stage of a Phase I trial to investigate the safety of oral insulin has been completed in six healthy patients. The mean insulin blood level rose and declined more slowly in treated subjects compared to those who received placebo; both groups were also given an intravenous injection of glucose solution. Mean glucose levels also declined more rapidly with oral insulin, as did C peptide levels, a marker for insulin levels. Results support data from animal studies and from fasting healthy subject trials. Further trials are expected to begin in early 1997 with an encapsulated form of oral insulin in both healthy and diabetic subjects.
Oral Salmon Calcitonin Turning to Cortecs' oral salmon calcitonin for osteoporosis, the company has been investigating the fact that there is large diurnal variation in bone marker excretion, obtained from a study in healthy elderly patients, which may affect time of calcitonin administration. In a recent Phase I trial conducted by Cortecs and using injectable calcitonin, morning or evening dosing was found to be equally efficacious in reducing bone turnover.
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