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Spherix Incorporated (Nasdaq: SPEX), an innovator in biotechnologyfor therapy in diabetes , metabolic syndrome and atherosclerosis; and providers oftechnical and regulatory consulting services to food, supplement,biotechnology and pharmaceutical companies, announced that itsPhase 2 diabetes clinical trial, designed to determine the minimumdose of D-tagatose capable of reducing HbA1c, found that theminimum 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 gTID), with the 2.5 and 5.0 g doses producing similar responses toone 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 dosereduced serum triglycerides vs. the 2.5 g dose by -42 mg/dl from amean of 180 mg/dl in the Evaluable Efficacy (EE) population. Thereduction in serum triglycerides became statistically significantin the Intent-To-Treat (ITT) population at three months oftreatment (-31 mg/dl, p=0.03) and the reduction essentially heldsteady at the six-month end-of-study visit (-29 mg/dl). In the single-blind study designed to establish the minimum dosecapable of causing a beneficial effect, three different doses ofD-tagatose were administered to patients orally with meals TID. Thecomparator was the 2.5 g dose. The study was designed with aminimum of 34 patients in each of the three groups for a total of102 evaluable patients. The primary endpoint for the study wasreduction in HbA1c after six months of treatment. In the minimumdose range, D-tagatose produced a -0.3% reduction in HbA1c in the7.5 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 gdose was 0.2% more than the 2.5 g dose in the ITT population. Unlike other drugs, D-tagatose lowered triglycerides withoutelevating LDL. In fact, D-tagatose in the 7.5 g dose reduced LDLvs. the 2.5 g dose by -11 mg/dl by the third month of treatment,although the difference was not statistically significant. Thereduction essentially held steady at the six-month end-of-studyvisit (-10 mg/dl). HDL was unchanged, increasing only between 0.3and 1.4 mg/dl over the entire course of the study vs. comparator.Analysis of patient subgroups in the U.S. and India with elevatedbody mass and/or HbA1c is in progress. "The decrease in triglycerides of more than 20% in patients with amean serum triglycerides level that is not even in the Highcategory supports our decision to begin an aggressive drugdevelopment program with D-tagatose in hypertriglyceridemia,atherosclerosis and the metabolic syndrome," said Dr. Claire L.Kruger, CEO of Spherix. "We are encouraged by the statisticallysignificant reduction in triglycerides in the ITT population, whichis usually difficult to achieve because patients in this populationneed only receive a single dose in the entire trial in order toqualify. However, this token dose requirement allows a largernumber of patients into the ITT population, which in turn makes iteasier to detect a smaller change with statistical significance ina minimum dose range finding trial." Source: Spherix Incorporated Additional References Citations. I am an expert from universal-laptop-acadaptor.com, while we provides the quality product, such as Long Life Laptop Batteries , Itouch Screen Protector, Universal AC Laptop Adapter,and more.
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