Spherix Incorporated announced positive interim Phase 3 results for the planned review of the NEET (Naturlose (D-tagatose) Efficacy Evaluation Trial) trial of D-tagatose in drug naive type 2 diabetic patients. This ongoing double-blind, placebo-controlled study is designed to detect a 0.5% change in HbA1c as its primary endpoint, with secondary endpoints establishing glucose, insulin and lipid profiles and measuring changes in body weight. The primary efficacy analysis will compare the change in HbA1c in patients receiving D-tagatose monotherapy vs. placebo at more than 40 sites in the USA and India, and seeks to complete 332 patients.
Results of the blinded interim data analysis of the Phase 3 trial demonstrate a significant reduction in variability of HbA1c levels, the primary endpoint of the trial. The observed data to-date indicate that the change in variability of HbA1c from baseline is favorable, and that the current sample size gives the study sufficient power to achieve the statistical significance for protocol defined differences between control and D-tagatose in HbA1c when the study reaches the planned number of patients completing treatment. The analysis noted that the results of the secondary variables, LDL, HDL, triglycerides, and body mass index (BMI), are very striking and are in agreement with that of the HbA1c results. These results demonstrate a significant decrease in the mean BMI at all time points evaluated compared to baseline. A consistent decrease of BMI and serum triglycerides was observed at each visit. A statistically significant reduction in HDL and LDL was also seen compared to baseline.
D-tagatose prevents the stimulation of insulin secretion, avoiding beta cell exhaustion and naturally lowers blood glucose levels.
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