SAN DIEGO, Jun 13, 2005 (BUSINESS WIRE) -- Today, Nutrition 21, Inc. (NXXI) reported results from a new clinical trial that show daily supplementation with Diachrome(R), a nutritional combination of chromium picolinate and biotin, can improve uncontrolled blood sugar levels and cardiovascular risk factors in people with type 2 diabetes on prescription medications in a managed care setting. The results of the randomized, double-blind, placebo-controlled, multi-center study that evaluated 369 subjects were presented at the American Diabetes Association (ADA) 65th Annual Scientific Sessions in San Diego, CA. A recent survey found that an estimated 67% of people with diabetes have poorly-controlled blood sugar levels, greatly increasing their risk of cardiovascular disease, blindness, and nerve and kidney damage over time.
The Diachrome study results included an analysis of an ethnically diverse population of people with diabetes receiving intensive and highly personalized care, who were already on a variety of prescription antidiabetic medications, yet still did not have their blood sugar levels at the recommended goal of (less than) 7% HbA1c. While there was a significant reduction in HbA1c overall in study participants taking Diachrome, the most dramatic improvements were seen in subjects with the most poorly controlled HbA1c levels at baseline (greater than (10%)). After 90 days, the blood sugar levels of these patients dropped significantly (greater than (1.9%-point drop in HbA1c)). Additionally, Diachrome significantly lowered LDL cholesterol (-21.9 mg/dL,) in subjects with poorly controlled cholesterol levels (greater than (200 mg/dL)) at baseline.
"These findings are significant. The average reduction in blood sugar levels is comparable to the effect typically seen when adding a second prescription therapy. There was no observed risk of hypoglycemia," said lead researcher Cesar Albarracin, M.D., Medical Director of Alpha Therapy in Corpus Christi, TX. "Diachrome's dual benefit for safely improving both blood glucose and cholesterol levels in the most severe diabetics is significant, as these subjects are generally the hardest to control, the most costly to care for and the most likely to develop significant complications."
Nutrition 21, Inc. conducted the landmark study in collaboration with XLHealth, a nationally recognized disease management firm handling chronically ill patients for the Centers for Medicare and Medicaid Services (CMS). "The presentation of this data is an important business milestone that will help facilitate the use of Diachrome in clinical practice," said Gail Montgomery, president and CEO, Nutrition 21. "Diachrome could be a safe, cost-effective means of helping the vast majority of people with diabetes that have poorly controlled blood sugar levels."
Certain ethnic minorities, including Hispanics have a higher prevalence of diabetes than Caucasians, and some minorities have higher rates of diabetes-related complications and death, according to the Agency for Healthcare Research and Quality. "More than 30 percent of the study participants were Hispanic, making this trial the first to examine the effects of Diachrome supplementation in this high risk population," said Dr. Albarracin.
Diachrome is a nutritional supplement specifically formulated for people with diabetes. It contains 600 mcg of chromium as Chromax(R) chromium picolinate and 2 mg of biotin. These two compounds are both Generally Recognized as Safe (GRAS) for use as ingredients in food and supplements. It is available for purchase by calling 1-866-DIACHROME or at www.diachrome.com.
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 chromium picolinate, which is the most-studied form of the essential mineral chromium. Nutrition 21 also developed Diachrome, which is available through diabetes educators or at www.diachrome.com. 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 www.nutrition21.com.