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Spherix Announces Statistically Significant Results in Phase 3 Study With D-tagatose in Type 2 Diabetes
Date:10/7/2010

ngs:  BioPartnering Europe, October 11-12 in London; and the Windhover Therapy Area conference, November 3-4 in Boston.

TriglyceridesBecause of the small number of patients enrolled in the NEET diabetes trial with triglyceride levels of 200 to 500 mg/dl, and a lack of patients with triglyceride levels above 500 mg/dl, it was not possible to conduct statistical analyses on that secondary endpoint in the current trial.  Dr. Lodder's previous research in an animal model of dietary-induced hyperlipidemia demonstrated an effect of D-tagatose on triglycerides, VLDL, LDL in blood, and on atherosclerosis in arterial walls.  Animals consuming Dtagatose exhibited a statistically significant five- to six-fold reduction in triglycerides compared with animals consuming sucrose.

"We plan to continue with our stated goal of investigating the development of D-tagatose as a therapy for reduction of triglycerides," Dr. Lodder said.

NEET Trial Design NEET is a double-blind, placebo-controlled trial with 356 treatment-naïve patients randomized to receive 15 grams of D-tagatose three times daily with meals for a period of up to one year as an adjunct to diet and exercise, or a placebo three times daily with meals for up to one year as an adjunct to diet and exercise.  Patients were treated for more than 10 months, and HbA1c levels were measured at two, six and 10 months after enrollment into the trial.  The average HbA1c level at the time of entering the trial was 7.5%. The NEET inclusion criteria for HbA1c in patients were screening (visit 1) and randomization (visit 2) values between 6.6% and 9.0%.

A modified Intent-To-Treat (ITT) definition was used in NEET.  The modified ITT population consisted of all randomized subjects who received at least one dose of their randomized treatment and had at least one post-treatment visit evaluating efficacy.  The PP population consisted of all ITT subjects who had 80% compli
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SOURCE Spherix Incorporated
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