Phase 2 study of D-tagatose for the treatment of hyperlipoproteinemias

Spherix announced results from its Phase 2 study of D-tagatose for the treatment of hyperlipoproteinemias. This single blind study was designed to determine the minimum dose of D-tagatose capable of reducing HbA1c after six months of treatment (primary outcome).  The study determined that the minimum dose capable of affecting HbA1c (7.5g three-times daily, or TID) was within the range of doses tested (2.5, 5.0, and 7.5g TID), with the 2.5 and 5.0g doses producing similar responses to one another, and the 7.5g dose producing a greater response.

Additionally, D-tagatose lowered triglycerides without elevating LDL. In fact, D-tagatose in the 7.5g dose reduced LDL vs. the 2.5g dose by -11 mg/dl by the third month of treatment, although the difference was not statistically significant. The reduction essentially held steady at the six-month end-of-study visit (-10 mg/dl). HDL was unchanged, increasing only between 0.3 and 1.4 mg/dl over the entire course of the study vs. comparator.

D-tagatose is a naturally occurring stereoisomer of D-fructose being investigated for the treatment of type 2 diabetes and hyperlipidemia.

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