October 07, 2010
Phase 3 study update of D-tagatose for type 2 diabetesSpherix announced results from its Phase 3 study of D-tagatose for the treatment of type 2 diabetes. This study, known as NEET (Naturlose Efficacy Evaluation Trial), is a double-blind, placebo-controlled trial with 356 treatment-naïve patients randomized to receive 15g 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. Data from the trial demonstrated that D-tagatose as a monotherapy in type 2 diabetes showed a statistically significant (p<0.05) reduction in HbA1c levels of 0.4% at 10 months in relatively healthy people with diabetes (U.S. Intent to Treat, Last Observation Carried Forward, n=101 and Global Per-Protocol (PP), n=92). The reduction was even more pronounced among PP patients treated in the U.S., and the reduction in HbA1c generally increased over the 10 months patients were treated.
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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