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Spherix Announces Statistically Significant Results in Phase 3 Study With D-tagatose in Type 2 Diabetes

ance with medication for 75% of the dosing time points and had no major protocol violations.  Last Observation Carried Forward (LOCF), a method in which the last results before a subject drops out of the trial are carried forward to the end of the trial, was used in the ITT population when data were missing due to circumstances such as loss to follow-up.  The trial was conducted at 34 sites in the U.S. and 23 sites in India.  The final patient numbers were 172 in the drug arm and 184 in the placebo arm (ITT), and 85 in the drug arm and 119 in the placebo arm (PP).  A total of 102 patients were enrolled at U.S. sites, and 254 patients were enrolled at India sites.  The trial was initially powered by design to detect a reduction in HbA1c of 0.5%, but the variance in HbA1c at each time point was smaller than the original design assumption, enabling a smaller change in HbA1c to be detected with statistical significance.  Secondary endpoints included glucose measures, insulin measures, lipid profiles and changes in body weight.Table 1.  Reduction in HbA1c Over TimePatient population2 months6 months10 monthsU.S. PP-0.4*  (n=51)

-0.6*  (n=29)

-1.1*  (n=20)U.S. ITT LOCF-0.3* (n=100)

-0.3* (n=101)

-0.4* (n=101)India PP-0.1 (n=150)

0.0 (n=117)

-0.2 (n=72)India ITT LOCF-0.2 (n=253)

-0.1 (n=254)

-0.2* (n=254)Global PP-0.2 (n=201)

-0.2* (n=146)

-0.4* (n=92)Global ITT LOCF-0.2* (n=353)

-0.2* (n=355)

-0.2* (n=355)Global ITT (7.5<HbA1c<9.0)-0.3 (n=175)

0.1 (n=134)

-0.5* (n=92)PP = Per-Protocol; ITT = Intent-to-Treat; LOCF = Last Observation Carried Forward* p<0.05; all other figures do not have statistical significanceAbout SpherixSpherix Incorporated was launched in 1967 as a scientific research company under the name Biospherics Research.  The Company now leverages its scientific and technical expertise and experience th

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