GlycoMark (1,5-Anhydroglucitol or 1,5-AG)

Recent Meeting Abstracts/Posters – Monitoring Therapy

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

David Kendall, Amylin Pharmaceuticals, Inc., John Holcombe, Eli Lilly and Company, et al.

Scientific Sessions of the American Diabetes Association – 2007

"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."

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

Cameron Lush, Amylin Pharmaceuticals, Inc., et al.

American Association of Clinical Endocrinologists 2007 Annual Meeting

"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."

The Use of 1,5-Anhydroglucitol (GlycoMark) to Detect Underlying Treatment Effects of Diabetes Pharmaceutical Agents

Antonio Ceriello, University of Warwick Medical School, et al.

European Association for the Study of Diabetes 2007 Annual Meeting (submitted)

"Data from these and additional studies indicate that 1,5-AG revealed underlying treatment effects on postprandial glucose control which were not readily apparent by A1C measurements."

The Use of Serum 1,5-Anhdroglucitol (GlycoMark), a Novel Diabetes Biomarker, in Clinical Drug Studies

Eric Button, GlycoMark, et al.

Fifth International Metabolic Diseases Drug Discovery & Development World Summit

 "1,5-AG is a novel diabetes biomarker of both postprandial hyperglycemia and short-term glycemic control which can be utilized in clinical drug studies."

Twelve Week Efficacy and Tolerability of Sitagliptin, a DPP-4 Inhibitor, in Japanese Patients with T2DM

Peter Stein, Merck, et al.

Scientific Sessions of the American Diabetes Association – 2006

 "In a subset that underwent a meal tolerance test, 2-hour postprandial glucose decreased by -69.2 mg/dL in the sitagliptin group compared with an increase of 11.7 mg/dL on placebo at week 12."

At week 12, 1,5-AG decreased by 4.45 ?g/ml in the sitagliptin-treated group compared with a decrease of 0.33 ?g/ml – a percentage change of 83% compared to a 8.6% absolute percentage change of A1C.

Serum 1,5-anhydroglucitol (GlycoMark) as a Marker of Glycemic Control in Subjects Receiving Twice-Daily Biphasic Insulin Aspart 70/30 (BIAsp 70/30) vs. Once-Daily Insulin Glargine in Patients with Type 2 DM on Oral Antidiabetic Agents – The INITIATE Trial

Alan Moses, Novo Nordisk, et al.

Scientific Sessions of the American Diabetes Association – 2005

"The dynamic range of 1,5-AG in the circulation makes it a useful marker of overall glycemic control as reflected by A1C and a potentially useful marker for subject with target or near target A1C levels who continue to have excessive postprandial glucose excursions."

Recent Meeting Abstracts/Posters – PPG and Short-Term Glycemia

Comparative Analysis of Three Glycemic Assays – A1C, 1,5-Anhydroglucitol, and Fructosamine

Steve Wittlin, University of Rochester, et al.

American Association of Clinical Chemistry 2007 Annual Meeting

"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."

Serum 1,5-Anhydroglucitol (GlycoMark) as an Adjunct to A1C Testing – Reflecting Both Postprandial Hyperglycemia and Short-Term Glycemic Control

John Buse, University of North Carolina, et al.

Scientific Sessions of the American Diabetes Association – 2006

 "As 1,5-AG is reflective of both postprandial hyperglycemia and short-term glucose control, this assay may be used to bridge the gaps in clinical understanding that A1C testing provides to help achieve optimal glycemic control."

Serum 1,5-Anhydroglucitol (GlycoMark) Is a Strong Predictor of Postprandial Hyperglycemia in Type 2 Diabetes Patients

Isao Kawasaki, Osaka, Japan, et al.

Scientific Sessions of the American Diabetes Association – 2005

 "To control postprandial hyperglycemia, serum 1,5-AG may be more useful than other clinical markers of glycemic control."

Potential Role of 1,5-Anhydroglucitol in Screening for Impaired Glucose Tolerance

Toshie Akutsu, Tokyo, Japan, et al.

Scientific Sessions of the American Diabetes Association – 2005

"Our study results suggest that FPG combined 1,5-AG yields the highest sensitivity for detecting patients with 2-hour glucose level of 140 mg/dl or greater, and may therefore be useful for detecting IGT patients."

Key Journal Publications

1,5-Anhydroglucitol and Postprandial Hyperglycemia as Measured by Continuous Glucose Monitoring in Moderately Controlled Patients With Diabetes

Dungan K, Buse J, Largay J, Wittlin S, et al.

Diabetes Care (2006) 29(6): 1214-1219

"Conclusions – 1,5-AG reflects glycemic excursions, often in the postprandial state, more robustly than A1C or fructosamine.  1,5-AG may be useful as a complementary marker to A1C to assess glycemic control in moderately controlled patients with diabetes."

Serum 1,5-Anhydroglucitol (GlycoMark) Levels in Children with and without Type-1 Diabetes

Nguyen T, Rodriguez L, Mason K, and Heptulla R

Pediatric Diabetes (In Press)

"Our findings suggest that despite good glycemic control, post-prandial glucose concentrations are elevated and that 1,5-AG showed a difference between controls and T1DM.  The data are comparable with previous studies in normal adults and those with T1DM and T2DM.  They support the use of 1,5-AG concentrations, together with A1C to evaluate therapy especially to target postprandial hyperglycemia."

Plasma Anhydro-D-glucitol (1,5-AG) as an Indicator of Hyperglycemic Excursions in Pregnant Women with Diabetes

Dworacka M, et al.

Diabetes Medicine (2006) 23(2): 171-175

"The plasma 1,5-AG level may be a useful marker of daily glucose excursion in pregnant women with diabetes, as an adjunct to HbA(1c) monitoring."

Circulating 1,5-Anhydroglucitol Levels in Adult Patients with Diabetes Reflect Logitudinal Changes of Glycemia

McGill J, Cole T, Nowatzke W, et al.

Diabetes Care (2004) 27(8): 1859-1865

"Over the 8-week monitoring period, values for 1,5-AG, A1C, and fructosamine were highly correlated, and the results were in good agreement with previous Japanese studies.  Furthermore, 1,5-AG responded rapidly and sensitively to population-based changes in glycemia, with the first significant change appearing at 2 weeks of treatment.  In contrast, A1C responded more slowly, and both A1C and fructosamine displayed more modest changes in value."

Serum 1,5-Anhydroglucitol (GlycoMark): A Short-Term Glycemic Marker

Buse J, Freeman J, Edelman S, Jovanovic L, and McGill J

Diabetes Technology and Therapeutics (2003) 5(3): 355-363

Review of previous studies focused on utility of 1,5-AG to reflect short-term glycemia

Key Journal Citations:

Assessing Glycemic Control with Self-Monitoring of Blood Glucose and A1C Measurements

Daily E (Scripps Clinic and Research Foundation)

Mayo Clinic Proceedings (February 2007) 82(2): 229-236

Potential Alternatives to A1C – "The 1,5-AG assay measures serum levels of a compound that competes with glucose at the renal tubule and was recently approved by the US Food and Drug Administration...Future studies may support the use of 1,5-AG as a means to detect postprandial glycemic excursions."

Prevalence and correlates of post-prandial hyperglycemia in a large sample of patients with diabetes

Bonora E, Corrao G, Ceriello, A, et al.

Diabetologia (2006) 49: 846-854

 "We chose our definitions of post-prandial hyperglycemia on the basis of treatment guidelines issued by the IDF and ADA...It is possible with the use of novel markers of post-meal glucose levels, such as depressed 1,5-anhydroglucitol levels, the prevalence of clinically significant post-prandial hyperglycemia might be different."

Diabetes, prediabetes, and cardiovascular risk: Shifting the paradigm

Deedwania C and Fonseca V

The American Journal of Medicine (2005) 82(2): 229-236

"A test that could easily detect the magnitude of 'real-life' postprandial glucose excursions would have great utility to identify high-risk patients at the early stage of dysregulation of glucose metabolism.  One possibility is testing for plasma levels of 1,5-anhydroglucitol (1,5-AG).  Unlike A1C levels, which reflect average plasma glucose levels of the past 2 to 3 months, 1,5-AG levels reflect short-term excursion in plasma glucose, on the order of 1 to 2 days.