PURCHASE, N.Y.--(BUSINESS WIRE)--Feb. 4, 2003--
First-of-Its Kind Alliance to Further Validate Efficacy of Diachrome(TM) for 16.7 Million Americans with Type 2 Diabetes
Nutrition 21, Inc. (Nasdaq: NXXI), a leading developer and provider of nutritional products and Diabetex Corporation, a member of the XLHealth family of companies and a leading diabetes disease management company, today announced an alliance to conduct a pivotal clinical study to test Diachrome(TM), a patented combination of chromium picolinate and biotin.
The research study aims to further confirm the efficacy of Diachrome as an adjunct nutritional therapy to prescription medication for people with Type 2 diabetes. Initial studies suggest that Diachrome is effective in improving cholesterol levels and reducing blood glucose levels in people with Type 2 diabetes - a cornerstone of diabetes management.
"Nutrition 21's partnership with a well respected, patient focused disease management company like Diabetex represents a significant milestone for our Company as we move aggressively forward in the development and marketing of our chromium-based, patented portfolio of branded products," said Gail Montgomery, President and CEO. "Diachrome is an excellent example of the Company's commitment to develop science-based therapeutic nutritional supplements for disease specific conditions."
The initial point of collaboration will be a 600-patient double-blind placebo-controlled clinical study in people with Type 2 diabetes to confirm the benefits of Diachrome on management of glucose and cholesterol levels, when used in conjunction with pharmaceutical treatments. Dr. Burcham Fuqua of Diabetex is overseeing the study, expected to be completed in June of 2004.
Diabetes management requires a multidisciplinary approach to patient care and costs the nation more than $150 billion. "Diabetex is committed to better health for each of the thousands of patients it helps support," said Paul Serini, Executive Vice President of Diabetex. "For these patients, the prospect of a proven nutritional therapy that is affordable, convenient, safe and effective is an exciting advance."
The preliminary research study with Diachrome presented at the 2000 International Diabetes Federation meeting demonstrated a unique synergy between chromium picolinate and biotin that significantly enhanced glucose metabolism. "Further scientific validation of Diachrome's efficacy to control glucose levels is strategically important to build medical acceptance for the brand's adoption as a nutritional adjuvant treatment protocol for people with Type 2 diabetes which is among the fastest growing health concerns in the nation," added Montgomery. Nutrition 21 is also conducting a study in cooperation with Children's Hospital in Oakland, CA, to evaluate efficacy of Diachrome in the juvenile Type 2 diabetes population.
This announcement comes on the heels of Nutrition 21's recent conclusion of a Duke University Medical Center study for Zeramax, its patented chromium picolinate-based supplement as a nutrition therapy for depression. The preliminary results, which showed significant improvement in the symptoms of atypical depression, will be published in the February 1, 2003 issue of the Journal of Biological Psychiatry.
About Nutrition 21, Inc.
Nutrition 21 is a developer and provider of nutritional products whose health benefits have been substantiated by clinical research. The market leader in nutritional chromium, Nutrition 21 currently holds 35 patents for nutrition products, including 22 for chromium compounds and their uses. More information is available at www.nutrition21.com.
Diabetex Corporation is a member of the XLHealth family of wellness and diabetes support and management companies. The Company was founded by doctors and healthcare executives in 1997. Diabetex was recently selected by the Federal government to design and conduct a comprehensive demonstration project proving the efficacy of managing chronically ill Medicare beneficiaries using the Company's support and management tools.
Using patient interactions and innovative data-management, stratification and prediction tools, Diabetex and XLHealth collect and analyze clinical and administrative data, including medical history and health attitudes, and create -- and then coordinate -- a customized preventive care plan for each patient and physician. In close coordination with the patient's physician, the Diabetex care plans address all co-morbidities of diabetes -- blood sugar control, renal conditions, cardiovascular conditions, eye care, foot care, clinical depression and overall weight control, exercise and nutrition. The Diabetex care plans are based upon nationally recognized clinical protocols, including those published by the American Diabetes Association.