Type II Diabetes
During the first quarter of 2010, we received confirmation from the DMEP that our new IND was accepted and, as a result, we may initiate a Phase 2 trial.
The frequency and onset of Type II diabetes and secondary hypogonadism have similar demographics based on age and other conditions and the Company believes the two groups are very similar. Twenty percent of the men in the Company’s studies of secondary hypogonadism were also confirmed diabetics. Previously, in a subset of hypogonadal men with elevated glucose, Androxal showed a statistically and clinically significant reduction in morning fasting glucose levels while elevating testosterone. With roughly 20 subjects per arm, Androxal doses of either 12.5 or 25 mg achieved a median reduction greater than 10 mg/dl of glucose in men with elevated fasting glucose levels. The change from baseline was statistically significant for both groups, p<0.02. By contrast, neither a commercial topical testosterone nor placebo achieved statistically or clinically significant reductions.