PARIS--Aug. 28, 2003--
- Results From Innovative Diachrome(TM) "Patient Experience Programme" (PEP) Reported at International Diabetes Federation (IDF) Congress
Nutrition 21, Inc. (Nasdaq: NXXI) - People with type 2 diabetes significantly reduced elevated blood sugar levels in twelve weeks, through the innovative "Patient Experience Programme" (PEP), designed to evaluate nutritional supplementation with Diachrome(TM), a novel combination of chromium picolinate and biotin, in "real-life" settings. The outcomes of the open-label PEP, which also included nutrition and diabetes counselling and glucose monitoring through diabetes educators, were presented today at the International Diabetes Federation (IDF) Congress.
PEP, created by Nutrition 21, Inc., enrolled patients through independent diabetes educators across the United States. All subjects had elevated glycosylated hemoglobin (HbA1c) levels above the American Diabetes Association's (ADA) recommendation of 7% or less, despite consumption of oral hypoglycemic agents (OHAs) for at least six months prior. HbA1c is a marker of long-term blood sugar control. Thirty subjects were provided educational materials, glucose monitors, and Diachrome nutritional supplements, which they took daily, while continuing their prescription medications. Each subject recorded his or her individual compliance and daily blood sugar test results. After 12 weeks, there was a significant reduction of 1.1 in average HbA1c levels. Eighteen of PEP participants who had baseline HbA1c levels above 8%, showed 1.8 decrease, which represented a greater than average reduction.
"The patients I enrolled experienced significant improvements in controlling blood sugar levels through participation in PEP," said June I. Merica, ANP, CDE, Indian Health Services (IHS). "One of my patients saw her HbA1c drop from 11.8% to 8.3%, while another one dropped from 7.6% to 6.3%."
PEP adds to a growing body of evidence in support of Diachrome as an efficacious, safe and cost-effective complementary therapy in diabetes care. "The positive outcomes from PEP combined with encouraging pre-clinical data on Diachrome, served as the catalysts for Nutrition 21 to invest in a major clinical study to be completed in June 2004," said Gail Montgomery, President and CEO. Nutrition 21, Inc. is collaborating with Diabetex Corporation, a member of the XLHealth family of companies and a leading diabetes disease management company, in 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, when used in conjunction with pharmaceutical treatments.
Diabetes is a chronic disease characterized by high blood sugar levels that affects 194 million people worldwide. According to the IDF, if nothing is done to slow the epidemic, the number of people with diabetes will exceed 333 million by 2025. It is the leading cause of blindness and visual impairment and the fourth main cause of death in adults in most developing countries. People with diabetes are two-to-four times more likely to develop cardiovascular disease (CVD). The World Health Organisation (WHO) estimates 16.6 million people around the world die of CVD each year.
Diachrome is a new nutritional supplement composed of chromium picolinate and biotin. These two ingredients are approved as Generally Recognised as Safe (GRAS) for use in food. Numerous peer-reviewed, clinical trials support that chromium picolinate is an effective and safe nutritional supplement for blood sugar level control. Biotin, also known as vitamin H, has independently demonstrated glucose and lipid-reducing effects.
About Nutrition 21
Nutrition 21 is a leading developer and provider of nutritional products, with health benefits substantiated by clinical research. The Company developed and markets Chromax, the leading brand of chromium, and holds 35 patents for nutrition products, 22 for chromium compounds and their uses. More information is available at www.nutrition21.com and www.diachrome.com.