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Study Results Show Diachrome(R) Improves Poorly-Controlled Blood Sugar Levels for People on Antidiabetic Prescription Medications

Findings Presented at 41st Annual Meeting of the European Association for the Study of Diabetes

ATHENS, GREECE -- September 13, 2005 -- 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 (EASD) 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 hemoglobin A1c (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, 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.


SOURCE: Nutrition 21

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