Results of Long-Term Study Evaluating Diachrome Presented at American Diabetes Association 66th Annual Scientific Sessions
Nutrition 21, Inc. (NXXI) reported results from a new clinical trial that shows long-term daily supplementation with Diachrome(R), a proprietary combination of chromium picolinate and biotin, can significantly improve blood sugar levels in people with type 2 diabetes who had poorly controlled blood sugar levels and were taking prescription antidiabetic medications. The results, which evaluated 28 people over nine months, were presented at the American Diabetes Association (ADA) 66th Annual Scientific Sessions in Washington D.C. on Saturday, June 10, 2006.
The new data come from an open-label extension phase to the previously reported 90-day, randomized, double-blind, placebo-controlled, multi-center study that evaluated 368 subjects taking daily Diachrome supplementation and showed a 0.53% average drop in HbA1c (p less than 0.05). The long-term study provided a further average decrease of 0.96% HbA1c (p less than 0.05). Ten of the 24 subjects who completed the nine-month study, or 42 percent, reached the American Diabetes Association's target HbA1c level of less than seven percent.
"These findings are significant because the patients demonstrated compliance with Diachrome as part of their diabetes management and saw continued decreases in HbA1c levels over the nine-month period. The average reduction in blood sugar levels is comparable to the effect typically seen when adding a second prescription therapy," said lead researcher Cesar Albarracin, M.D., Medical Director of Alpha Therapy in Corpus Christi, TX. "Another important finding of the trial is that there were no significant product-related adverse events reported, further supporting Diachrome's safe use with commonly prescribed medications."
According to the American Diabetes Association, there are 18.2 million people in the United States, or 6.3 percent of the population, who have diabetes. The economic impact of diabetes was estimated at $132 billion in 2002, including direct medical expenditures and the costs of lost productivity. From 1997 to 2002, the per capita annual cost of diabetes rose 30 percent.
"Given the increasing public health burden associated with the escalating incidence of diabetes, we believe the market potential for Diachrome, as a safe, effective and inexpensive adjunct therapy to diabetes disease management is significant," said Paul Intlekofer, President and Chief Executive Officer of Nutrition 21. "We've taken considerable steps to substantiate Diachrome's efficacy and safety. Healthcare providers and consumers should feel confident in including Diachrome as a cost-effective solution in their diabetes management regimen."
Diachrome is a non-prescription, nutrient-based insulin sensitizer for people who have type 2 diabetes and has shown a positive dual effect on blood sugar and lipid metabolism in clinical studies and practice. The active ingredients in Diachrome, 600 mcg of chromium as Chromax(R) chromium picolinate and 2 mg of biotin, are deemed safe by the United States Food and Drug Administration. Diachrome can be safely and effectively used in combination with multiple prescription oral diabetes, lipid and hypertension medications and is currently being sold nationwide at CVS/pharmacy in the Home Diagnostic/Diabetes Care section.
About Nutrition 21:
Nutrition 21 is a nutritional bioscience company and the maker of chromium-based supplements with health benefits substantiated by clinical research. The company markets Chromax(R) chromium picolinate, http://www.chromax.com/, which is the most-studied form of the essential mineral chromium. Chromax is now available through food, drug and mass retailers nationwide. Nutrition 21 also developed Diachrome(R), http://www.diachrome.com/ , a proprietary adjunct nutritional therapy for people with type 2 diabetes. Nutrition 21 holds 36 patents for nutrition products and uses, 27 of which are for chromium compounds and their uses. More information is available at http://www.nutrition21.com.