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news.Primary endpoint showed reduction in HbA1c after 6 months of administration of drug
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Spherix has announced positive preliminary results from phase-II clinical trial of Naturlose (D-tagatose), in the treatment and management of Type 2 diabetes.
The phase-II trial was single-blind, prospective, randomized, multicenter study, which evaluated the minimum oral dose of Naturlose capable of causing a beneficial effect on HbA1c, and the safety of such doses. Naturlose was administered orally with meals at three different doses, 2.5g, 5.0g, and 7.5g.
The primary endpoint for the study showed reduction in HbA1c after 6 months on the drug. After 6 months on drug, the patients in the 7.5g group experienced an average reduction of 0.3% in HbA1c from the HbA1c of the 2.5g group.
For the same 6-month period, the 5.0g group averaged a reduction in HbA1c of 0.05% from the 2.5g group.
The phase-II trial is expected to be completed in early 2010.
Claire Kruger, CEO of Spherix, said: “The results of this ongoing Phase 2 study are encouraging and reaffirm our belief that Naturlose may be a valuable treatment option for patients with Type 2 diabetes.”
“Naturlose, administered at three separate low doses, proved to be effective for at least 6 months in reducing HbA1c, a key indicator of Type 2 diabetes that monitors glycated hemoglobin in the blood. These data, combined with the fact that Naturlose is a naturally occurring compound with no known contraindications to current Type 2 diabetes treatments, continues to lead us to believe that there will likely be a place for Naturlose in the treatment regime as either a stand-alone or an adjunct therapy. In addition, the effect on serum lipoproteins may lead to a role for Naturlose in the treatment of atherosclerosis and the metabolic syndrome,” he added.