Nutrition 21, Inc. (NASDAQ: NXXI) announced new published results from a 447 subject, randomized, double-blind, placebo-controlled clinical study that showed Diachrome?, a patented combination of chromium picolinate and biotin, significantly improved glycemic control in patients with poorly controlled blood sugar levels who were being treated with oral anti-diabetic medication (OADs).
Patients in the treatment group showed significant improvements in glycemic control (A1C) compared with placebo (an absolute decrease of 0.54%). The greatest improvement was seen in those patients with the poorest glycemic control (baseline A1C levels equal to or greater than 10%). These patients saw an additional absolute A1C decrease of 1.76% despite the fact that they were taking one or more OAD medications.
The American Diabetes Association?s (ADA) recommended goal for type 2 diabetes patients is an A1C level below 7.0%. Lowering A1C by just 1%, especially in patients with poor blood sugar control, can delay or prevent serious complications, reduce diabetes-related deaths and reduce healthcare costs.
?Uncontrolled, obese and overweight type 2 diabetes patients present an ongoing clinical challenge to health professionals. Prescribing another anti-diabetic medication can increase the risk of unwanted side effects, including weight gain or hypoglycemic events, and could place an added financial burden on the patient,? said Cesar Albarracin, MD, lead investigator and a leader in the field of nutritional management of type 2 diabetes. ?This study shows that adding Diachrome to anti-diabetic medications can help patients reach their blood sugar goal simply, effectively and safely.?
About the study
The randomized, double-blind, placebo-controlled, 90-day study, published online in Diabetes/Metabolism Research and Reviews (http://www3.interscience.wiley.com/cgi-bin/abstract/114263457/ABSTRACT), measured reductions in A1C, fasting glucose and lipids in 447 obese and/or overweight adults with type 2 diabetes on oral anti-diabetic medications. Safety and tolerability were also assessed. Results showed a significant reduction in A1C levels for the treatment group (-0.54%) compared with the placebo group (-0.34%). The highest risk patients (baseline A1C equal to or greater than 10%) showed an even greater improvement in A1C when compared to placebo (-1.76% vs. -0.68%).
Fasting glucose levels, a measure of blood sugar after one has not eaten for at least eight hours, also showed significant reductions in the entire treatment group (-9.8 mg/dL) compared with placebo (0.7 mg/dL). Once again, the decrease was greater for the highest risk patients when compared with placebo (-35.8 mg/dL vs. 16.2 mg/dL). Diachrome was well tolerated and adverse effects and the clinical safety profile for the active group was not significantly different from placebo.
Those individuals receiving chromium picolinate plus biotin, in the form of Diachrome, also experienced a significant decrease in triglycerides to HDL ratio compared to the placebo group (p=0.05 vs. placebo). A study published in the March 2007 issue of the American Journal of the Medical Sciences also showed that chromium picolinate plus biotin added to OADs helped improve lipid control over a 30-day period by improving triglycerides-to-HDL ratio and LDL-to-HDL ratio.
?The publication of this landmark study, which followed a phase III pharmaceutical-equivalent design, reinforces our belief that Diachrome will become a standard tool for public and private healthcare professionals charged with managing the growing epidemic of type 2 diabetes,? said Paul Intlekofer, CEO of Nutrition 21. ?Diachrome?s drug-like effects in safely and effectively improving both blood glucose and cholesterol levels in the most severe diabetes patients is significant, as this population is generally the hardest to control, the most costly to care for and the most likely to develop complications. With these clinical research outcomes, Diachrome?s drug retail presence will expand beyond CVS and Walgreens.?
The form of chromium in Diachrome, Chromax? chromium picolinate, that was used in these studies has been recognized as safe by many of the world?s leading government and academic research institutions, including the U.S. Food & Drug Administration (FDA), the Institute of Medicine and the UK?s Food Standards Agency. In addition, both Chromax chromium picolinate and biotin have been deemed safe by the FDA and are also Generally Recognized as Safe (GRAS) for use in foods and supplements.