Naturlose D-tagatose: Phase III data

In the double-blind, U.S. and Indian Phase III NEET trial in 356 treatment-naïve Type II diabetics, 15 g thrice-daily Naturlose led to a significant placebo-adjusted reduction of 0.4% at 10 months in the global intent-to-treat (ITT) population (n=185; p=0.003). In the global per protocol (PP) population (n=92), Naturlose also led to a significant placebo-adjusted reduction of 0.4% at 10 months (p<0.05). More specifically, Naturlose led to a significant placebo-adjusted reduction of 1.1% at 10 months in the U.S. PP population (n=20; p<0.05). However, the reduction was not significant in the Indian PP population at 10 months (n=72; 0.2%). No treatment-related serious adverse events were reported. Spherix said the trial protocol included analyses of several ITT and PP populations, but did not indicate a specific population for the primary endpoint. The PP population consisted of all patients who had 80% compliance with medication for 75% of the dosing time points and had no major protocol deviations. ...