New Studies Confirm Role of New GlycoMark Blood Test to Detect Underlying Treatment Effects Not Revealed by the Gold Standard Hemoglobin A1C Test in Patients with Diabetes Important Implications for Diabetes Patient Care and Pharmaceutical

Clinical Research Studies

    CHICAGO and KANNAPOLIS, N.C., June 22 /PRNewswire/ -- Research
 presented at the 67th Annual Scientific Sessions of the American Diabetes
 Association (ADA) in Chicago and recent medical conferences underscore the
 utility of the GlycoMark 1,5-anhydroglucitol (1,5-AG) blood test to detect
 underlying treatment effects in patients with diabetes. These treatment
 effects were not readily revealed by the gold standard hemoglobin A1C
 diabetes test.
     Although the A1C test provides important information about how blood
 glucose has behaved over the preceding two or three months, the test does
 not provide specific information on blood glucose performed right after
 meals. This is a critical measurement because a growing body of evidence
 suggests that controlling after-meal glucose levels plays a significant
 role in achieving optimal glycemic control and reducing the burden of
 cardiovascular complications, the leading cause of death in patients with
     In contrast, GlycoMark provides a specific measure of average
 after-meal glucose levels over a period of one to two weeks with one single
 blood test -- revealing potentially abnormal after-meal glucose elevations
 that would otherwise go undetected by the A1C test. In a recent study
 published in the American Diabetes Association Diabetes Care journal
 (Dungan et al. Diabetes Care 2006; 29 (6): 1214-1219), it was shown that
 the GlycoMark 1,5-AG test reflected after-meal glucose levels more robustly
 than the A1C test. The study also showed that GlycoMark was able to reveal
 dramatically different after-meal glucose levels in patients with similar
 A1C levels.
     In studies presented at the 67th Annual Scientific Sessions of the
 American Diabetes Association and other recent meetings, the use of
 GlycoMark as a specific measure of after-meal glucose levels was confirmed.
 The studies also show that GlycoMark is particularly valuable in detecting
 underlying treatment effects on after-meal glucose levels. These findings
 have important implications for patient care and pharmaceutical research as
 the reduction of after-meal glucose rises is a key objective of diabetes
 drug therapy.
     The studies are as follows:
     Exenatide Improves Postprandial Glucose (PPG) Control in Patients With
 Type 2 Diabetes as Measured by 1,5-Anhydroglucitol (GlycoMark)
     David Kendall, Amylin Pharmaceuticals, Inc.
     Abstract/Poster Excerpt: Previous studies have shown that as A1C nears
 7%, PPG becomes the major contributor to overall glycemic control. As such,
 1,5-AG may be a useful complement to A1C to reflect PPG in patients with
 T2DM treated with agents that target PPG. In this post-hoc analysis, the
 increase in 1,5-AG confirms previously reported improvements in PPG in
 exenatide-treated patients.
     Scientific Sessions of the American Diabetes Association - 2007
     1,5-Anhydroglucitol (GlycoMark), a PPG Excursion Marker In Pramlintide
 Treated Subjects
     Juan Frias, Amylin Pharmaceuticals, Inc.
     Abstract/Poster Excerpt: Conclusions - Despite similar reductions in
 A1C, the change in 1,5-AG levels was consistent with improvement in PPG
 control in pramlintide-treated subjects, as measured by SMBG. 1,5-AG as a
 complement to A1C may be a useful marker of PPG control.
     American Association of Clinical Endocrinologists 2007 Annual Meeting
     Glycemic Instability Estimated By 1,5-Anhydroglucitol Persists Even
 After Normalization of A1C By Treatment in Patients With Type 2 Diabetes
     Toshikzau Yamanouchi, University of Teikyo
     Abstract/Poster Excerpt: Glycemic instability (glycemic excursions or
 postprandial hyperglycemia as measured by 1,5-anhydroglucitol) in diabetic
 patients is not easily restored for long periods even with treatment that
 maintains normoglycemia, as estimated by A1C levels.
     Scientific Sessions of the American Diabetes Association - 2007
     1,5-anhydroglucitol and Postprandial Hyperglycemia as Assessed by Self
 Monitoring of Blood Glucose in Japanese Patients with Moderately Controlled
     Yutaka Mori, et al., Utsunomiya National Hospital
     Abstract/Poster Excerpt: 1,5-AG has been shown to reflect glycemic
 excursions, often in the postprandial state, more robustly than A1C or
 glycated albumin.
     Scientific Sessions of the American Diabetes Association - 2007
     Comparative Analysis of Three Glycemic Assays - A1C,
 1,5-Anhydroglucitol, and Fructosamine
     Steve Wittlin, University of Rochester
     Abstract/Poster Excerpt: As 1,5-AG correlates significantly to all
 independent variables, this appears to be indicative of its utility as a
 marker of short-term glycemia and glycemic excursions.
     American Association of Clinical Chemistry 2007 Annual Meeting
     Other Clinical Drug Studies and Trials
     In addition to the previously mentioned studies using GlycoMark,
 exenatide (Byetta) and pramlintide (Symlin), GlycoMark has been or is being
 used in studies with other drug agents such as sitagliptin (Januvia),
 biphasic insulin aspart 70/30 (Novolog Mix 70/30) in the INITIATE Trial,
 and lispro insulin mixture (Humalog Mix) in the DURABLE trial. GlycoMark is
 also being used in several clinical drug studies and trials which have yet
 to be made public.
     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, and Specialty Laboratories. The test is also available at
 most major contract research organizations for pharmaceutical research
     GlycoMark is being commercialized by a partnership between Toyota
 Tsusho America (New York, NY), Nippon Kayaku (Tokyo, Japan) and the
 BioMarker Group (Kannapolis, NC). GlycoMark activities are centered in the
 North Carolina Research Campus in Kannapolis, North Carolina, a 350-acre
 life sciences hub started by billionaire David H. Murdock.
     More information about GlycoMark may be found at

SOURCE GlycoMark

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