Spherix Phase 2 Trial With D-tagatose Determines Minimum Dose For HbA1c And Triglycerides
BETHESDA, Md., Dec. 9, 2010 /PRNewswire-FirstCall/ -- Spherix Incorporated (Nasdaq: SPEX), an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that its Phase 2 diabetes clinical trial, designed to determine the minimum dose of D-tagatose capable of reducing HbA1c, found that the minimum dose capable of affecting HbA1c (7.5 g three-times daily, or TID) was within the range of doses tested (2.5, 5.0, and 7.5 g TID), with the 2.5 and 5.0 g doses producing similar responses to one another, and the 7.5 g dose producing a greater response.
In addition, by the end of the six-month trial, the 7.5 g dose reduced serum triglycerides vs. the 2.5 g dose by -42 mg/dl from a mean of 180 mg/dl in the Evaluable Efficacy (EE) population. The reduction in serum triglycerides became statistically significant in the Intent-To-Treat (ITT) population at three months of treatment (-31 mg/dl, p=0.03) and the reduction essentially held steady at the six-month end-of-study visit (-29 mg/dl).
In the single-blind study designed to establish the minimum dose capable of causing a beneficial effect, three different doses of D-tagatose were administered to patients orally with meals TID. The comparator was the 2.5 g dose. The study was designed with a minimum of 34 patients in each of the three groups for a total of 102 evaluable patients. The primary endpoint for the study was reduction in HbA1c after six months of treatment. In the minimum dose range, D-tagatose produced a -0.3% reduction in HbA1c in the 7.5 g dose group vs. the 2.5 g dose group in the EE population, from a mean randomization HbA1c of 7.4%. The reduction of the 7.5 g dose was 0.2% more than the 2.5 g dose in the ITT population.
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