Has fear of a hypoglycemic event—rather than hypoglycemic events per se—been previously used as an endpoint in a clinical study? It’s an endpoint in the phase-2 study of LY2605541 (jointly owned by LLY and B-I):
Study results showed that in addition to clinical results showing a statistically significant 48 percent baseline adjusted reduction in nocturnal hypoglycaemia compared with insulin glargine [0.25 vs. 0.39 events/ 30 days/patient, after adjusting for baseline hypoglycaemia events (p=0.020)], patients treated with LY2605541 reported a statistically significant reduction in the anxiety and fear associated with experiencing a hypoglycaemic event based upon the Adult Low Blood Sugar Survey (ALBSS).
LY2605541 is yet another drug whose sponsors seek to chip away at the huge market for SNY’s Lantus.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”