Findings Presented at 41st Annual Meeting of the
European Association for the Study of Diabetes
ATHENS, Greece, Sept. 13 /PRNewswire-FirstCall/ -- A sub-set of analysis
from a Diachrome(R) XLHealth clinical trial demonstrates that adding daily
supplementation with Diachrome to prescription treatment regimens can
significantly improve glycemic control in poorly controlled blood sugar levels
in people with type 2 diabetes. The results of this study conducted in
collaboration with XLHealth, a U.S. based and U.S. nationally recognized
disease management firm handling chronically ill patients for the Centers for
Medicare and Medicaid Services (CMS), were presented today at the 41st Annual
Meeting of the European Association for the Study of Diabetes in Athens,
Greece.
The randomized, double-blind, placebo-controlled, multi-center 12-week
study was designed to examine the efficacy of Diachrome as an adjunct to
medications in 369 patients with type 2 diabetes. This analysis of the trial
looked specifically at 60 patients who had HbA1c greater than or equal to 10%
and were taking one or more oral antidiabetic medication, including:
sulfonylureas, biguanides, and thiazolidinediones. Study participants taking
Diachrome with one or more antidiabetic medications saw an average range of
0.7 - 1.9% point reduction in HbA1c levels. The study also showed that
insulin resistance was significantly reduced (P<0.05) in those taking
thiazolidinediones and Diachrome. In addition, there were no adverse reports
of hypoglycemia in these patients.
"Diachrome's impact in the more severe diabetes cases is positive, as
these patients can be the hardest to control and are more likely to develop
debilitating and costly disease-related health complications such as
amputation and heart disease," said Paul Serini, executive vice president of
XLHealth. "Given the high cost of diabetes care, those of us involved in the
delivery of healthcare should look carefully at complementary, cost-effective
nutritional therapies, like Diachrome, and their potential benefits for
patients and third-party payors."
Nutrition 21 (Nasdaq: NXXI), the maker of Diachrome, and XLHealth recently
announced an agreement to make Diachrome available to physicians participating
in the Center for Medicare and Medicaid (CMS) sponsored-Medicare Health
Support (formerly known as the Chronic Care Improvement Program) program in
Tennessee. XLHealth's Medicare Health Support program, created by U.S.
Congress as part of the 2003 Medicare Modernization Act, will begin to address
the need for diabetes management by reaching out to 20,000 Medicare patients
in Tennessee who are living with diabetes and heart failure.
"We are confident that these new scientific findings and the treatment
success that will be seen in the XLHealth Medicare Health Support program will
fuel further adoption of Diachrome in diabetes care," said Gail Montgomery,
president and CEO of Nutrition 21.
The Economic Toll of Diabetes
At least 171 million people worldwide have diabetes. The World Health
Organization (WHO) estimates that anywhere from 2.5% to 15% of healthcare
budgets are spent on diabetes-related illnesses depending on local diabetes
prevalence and the sophistication of the treatment available. Findings from
the Diabetes Control and Complications Trial, a 10-year clinical trial
conducted by the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK), indicate that a low-cost intervention that decreases HbA1c
could be beneficial to patients, third party payors and society as a whole.
A recent economic analysis conducted by Thomas Jefferson University and
published in the August 2005 issue of the publication Disease Management,
demonstrated that daily use of Diachrome in addition to traditional
anti-diabetic medications could deliver a potential average three-year cost
savings of up to $52.9 billion for patients within the United States already
diagnosed with diabetes, plus a lifetime cost savings of $42 billion for newly
diagnosed patients annually as a result of the therapy's effect on HbA1c.
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.
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, which is the
most-studied form of the essential mineral chromium. The US Food and Drug
Administration has recently allowed a qualified health claim for chromium
picolinate that confirms that it is safe for use in people with insulin
resistance and at possible risk for type 2 diabetes. The company also markets
Diachrome(R), a chromium picolinate and biotin supplement specifically
formulated for people with 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.
SOURCE Nutrition 21
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Related links:
http://www.nutrition21.com
CONTACT:
Stacey Antine, MS, RD, Nutrition 21,
+1-914-701-4567; or Kristina Chang, +1-212-453-2277, for
Nutrition 21
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