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Spherix Announces Post-Hoc Analysis of Phase 3 Trial With D-Tagatose in Diabetes
Date:12/2/2010

o at 10 months of therapy in the Per Protocol population). BMI is an indirect measure of adiposity, which in turn measures the ratio of fat mass to the mass of the whole body. Differences in BMI may have contributed to the changes seen in HbA1c reduction in the two cohorts, because patients must have enough adipocytes that are large enough to enable body fat to act as an endocrine organ.

Differences in BMI between the US and India have been well documented; according to the 2010 WHO Global Database on BMI, 66.9% of the population of the USA was overweight (defined as BMI>25), while only 4.5% of the population of India had a BMI>25. Consistent with WHO data, in the Biospherics Phase 3 trial the BMI of patients from India was lower than in patients from the US. The mean BMI across all visits was lower in the Indian population than in the US, and the distribution was essentially Gaussian ("bell-shaped") (see Table 2). In the US population, the mean BMI across all visits (v1-v14) was significantly higher than in India and the BMIs were skewed toward higher values (i.e., BMIs>28.3). As a result, the US population is more likely to have sufficient adipocytes that are large enough to enable body fat to act as an endocrine organ.

Triglycerides are used by the body to transport fats from one location to another. Interestingly, the mean serum triglycerides for patients in India at randomization was lower than the mean for the patients in the US (Table 2). Serum triglycerides were also directly correlated with BMIs through all of the months on tagatose therapy (Table 1). In addition, as observed in other studies [Khan, 2007], serum triglycerides were directly correlated to HbA1c. Patients with higher HbA1c (poorer glucose control) tended to also have higher triglycerides.

The mean BMI is an important factor in interpreting results from the current Phase 3 Type 2 diabetes trial because BMI is an indirect measure of the amount of fat stored in adipo
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SOURCE Spherix Incorporated
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