"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-na ve 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% compliance 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.

SOURCE Spherix Incorporated