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DURABLE Clinical Trial Results Show GlycoMark is Key Test for Managing Patients with Diabetes

Additional Studies Indicate GlycoMark May Be a More Effective Monitor Than Hemoglobin A1C of Exenatide, Sitagliptin, Pramlintide and Prandial Insulin

Therapies in Certain Diabetic Populations

SAN FRANCISCO, June 7 /PRNewswire/ -- GlycoMark, Inc. announced today results from the ongoing DURABLE clinical trial showing that the GlycoMark blood test is a better reflection of glucose, particularly after-meal glucose levels, than the gold standard hemoglobin A1C test in moderately controlled patients with diabetes. These findings were reported by Kathleen Dungan, MD, of Ohio State University (Columbus, OH) and investigators from Eli Lilly (Indianapolis, IN) at the American Diabetes Association's 68th Annual Scientific Sessions (ADA) in San Francisco.

This is the largest clinical study to evaluate the clinical utility of GlycoMark to reflect after-meal glucose levels with 2,094 patients enrolled from 11 countries. The DURABLE trial (Assessing the Durability of Basal vs. Lispro Mix 75/25 Insulin Efficacy) confirms results from a smaller population study completed by John Buse, MD (University of North Carolina), Steven Wittlin, MD (University of Rochester), and Kathleen Dungan, MD, published in the medical journal Diabetes Care in June 2006.

In the study, the 1,5-Anhydroglucitol blood test (GlycoMark) correlated more strongly than hemoglobin A1C with all self-monitored plasma glucose (SMPG) parameters, particularly after-meal glucose levels, in moderately controlled patients with A1C levels less than 8.0%. Dr. Dungan concluded, "The data support the use of 1,5-anhydroglucitol, in conjunction with A1C, in moderately controlled patients with type 2 diabetes."

"This large clinical study validates the important role of the GlycoMark test to effectively monitor patients with diabetes," said Eric Button, President of GlycoMark, Inc. "Although patients may appear to be adequately controlled by A1C results, it may not readily reveal elevated postprandial spikes which are associated with dangerous cardiovascular complications. GlycoMark can detect 'hidden' glucose spikes, allowing physicians to target these spikes with specific treatments."

In a retrospective examination of studies (see below) evaluating the use of GlycoMark to monitor exenatide, pramlintide, sitagliptin, and biphasic insulin therapies, GlycoMark reflected changes in after-meal glucose levels more dynamically than A1C in moderately controlled patients - underscoring the ability of GlycoMark to detect underlying treatment effects on after-meal glucose not revealed by A1C. The study, "The Use of 1,5-Anhydroglucitol (GlycoMark) to Monitor New Classes of Therapies for Managing Post-meal Glucose in Patients with Diabetes," was presented at the recent American Association of Clinical Endocrinologists 2008 annual meeting in Orlando, Florida. Authors of the study included Steven Wittlin (University of Rochester), Toshikazu Yamanouchi (Teikyo University School of Medicine) and Antonio Ceriello (Warwick Medical School).

Exenatide Improves Postprandial Glucose (PPG) Control in Patients With Type 2 Diabetes as Measured by 1,5-Anhydroglucitol (GlycoMark)

Reference: Scientific Sessions of the American Diabetes Association - 2007 (David Kendall)

1,5-Anhydroglucitol (GlycoMark), a PPG Excursion Marker In Pramlintide-Treated Subjects

Reference: American Association of Clinical Endocrinologists 2007 Annual Meeting (Cameron Lush)

Efficacy and Safety of Sitagliptin Monotherapy in Japanese Patients with Type 2 Diabetes

Reference: Diabetes Research and Clinical Practice 2008 (Kenji Noaka)

Does serum 1,5-AG establish a relationship between improvements in HbA1c and postprandial glucose excursions? Supportive evidence utilizing the differential effects between biphasic insulin aspart 30 and insulin glargine.

Reference: Diabetic Medicine 2008 (Alan Moses)

About GlycoMark

GlycoMark is an FDA approved test for monitoring intermediate glycemic control by measuring the levels of a monosaccharide 1,5-anhydroglucitol (1,5- AG) in blood. Multiple published studies in peer-reviewed journals have shown that the 1,5-AG test is a specific index of postprandial hyperglycemia (elevated after-meal glucose levels) and short-term glycemic control - providing a useful complement to A1C testing. GlycoMark is being used in clinical practices nationwide and is available at major reference laboratories including Quest Diagnostics, LabCorp, Esoterix, Mayo Medical Laboratories, ARUP Laboratories, and Specialty Laboratories. The test is also available at most major contract research organizations for pharmaceutical research studies.

GlycoMark was recently included in the International Diabetes Federation (IDF) Global Diabetes Care Guidelines as an emerging tool to measure after-meal glucose levels.

GlycoMark, Inc. is based in New York, New York and Winston-Salem, North Carolina.

SOURCE GlycoMark, Inc.
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