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.

See Also:

• eDrugSearch.com Appears on The Morning Show with Mike and Juliet



• Be Beach Happy and Gain the Toned, Slimmer Summer Body You Want This Summer



• Beauti-ceuticals Nutrition and Skin Care Meet for Healthiest Skin Results



• Type 2 Diabetes Patients Taking Exenatide Once Weekly, a Phase 3 Investigational Diabetes Therapy, Showed Improvements in Glycemic Control, Weight



• Announcing a Mind, Body and Nutrition Transformation for Women Over 40

[Via Healthcare]