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Sanofi Announces Upcoming Launch of MyStar Extra, the First Self-Monitoring Blood Glucose Meter With Estimated A1c

At the annual meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain, Sanofi (EURONEXT : SAN and NYSE : SNY) recently presented the innovative blood glucose meter MyStar Extra®, the first self-monitoring device that provides robust estimates of the A1c value, a key indicator for long-term glucose control.[3],[4] The hemoglobin A1C (HbA1C) assay has become the cornerstone for the assessment of diabetes control and A1c test results are widely used to guide treatment decisions.[5],[6] Especially convenient for people starting on insulin or using insulin, MyStar Extra® is a supportive meter, designed to help people with diabetes be engaged in their insulin management and treatment plan.[7],[8],[9]

Researchers Identify a Metabolite as a Biomarker of Diabetes Risk

Type 2 diabetes (T2D) is the most common form of diabetes and is associated with many complications. T2D is preventable through weight control and exercise; however, many individuals are unaware that they are at risk and do not change their lifestyle in time to avoid disease.

ITN Type 1 Diabetes Study Identifies Subset of Patients with Strong Response to Therapy

Primary results from a new clinical trial show that patients with type 1 diabetes treated with the monoclonal antibody teplizumab (MacroGenics, Inc.) exhibit greater preservation of C-peptide, a biomarker of islet cell function, compared to controls. Further analyses identified a discrete subset of the treatment group that demonstrated especially robust responses (“responders”), suggesting that these patients could be identified prior to treatment. The trial, entitled “Autoimmunity-Blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes” (AbATE), was conducted by the Immune Tolerance Network (ITN). The results are available online and will be published in the November issue of the journal Diabetes.

The AbATE study, led by Kevan Herold, MD (Yale University), tested teplizumab, which targets the CD3 receptor found on T cells, in patients with new-onset type 1 diabetes. CD3 is required for T-cell activation, which can lead to the destruction of insulin-producing beta cells. A previous ITN study with teplizumab showed that a single course of the drug slowed C-peptide decline in new-onset patients for a year, after which the effects waned. The aim of the AbATE study was to test whether C-peptide preservation could be prolonged by administering two courses of teplizumab, one year apart.

In this open-label, Phase II study, 77 new-onset patients (ages 8 to 30 years old) were randomized to receive either teplizumab or a control. Those in the treatment arm received the scheduled treatment consisting of two 14-day courses of teplizumab, one year apart. Both arms received intensive diabetes care from certified diabetes educators and were followed for two years. The primary endpoint compared C-peptide preservation between the two groups.

After two years, the teplizumab-treated group showed significantly greater preservation of C-peptide (75-percent higher responses compared to the control group).

Further analysis revealed that within the treatment arm two groups of patients could be distinguished based on their C-peptide levels: one group, considered “responders” (22/49), showed very little C-peptide decline over the course of the study (only a 6 percent reduction from baseline), while the “non-responders” (27/49) exhibited a similar rate of C-peptide decline as the control group (less than 40-percent reduction from baseline).

Investigators measured various biomarkers and cell types that might distinguish between these two groups. They found that, at trial entry, “responders” had lower hemoglobin A1c levels (a marker of glucose concentration in the blood) and used less insulin at baseline, compared to “non-responders”. Differences in specific T-cell subsets also distinguished between the two groups at baseline, suggesting that immune status might contribute to drug responsiveness. However, further studies will be required to confirm these results.

“This overall approach to identifying characteristics of individuals most likely to respond to therapies shows great promise because the responders in this study experienced a robust and prolonged drug effect,” said Dr. Herold. “This type of response has not been seen in other studies of immune therapies.”

Type 1 diabetes is a disease marked by immune destruction of insulin-producing beta cells in the pancreas. New-onset patients usually have 20 to 40 percent of their normal beta cell mass remaining, which is still capable of producing insulin. Preserving this remaining mass, even temporarily, could improve long-term clinical outcomes.

Immune modulators, like teplizumab, represent a promising means of inducing tolerance; however, no drug has been shown to prevent or reverse disease, and only a few have temporarily delayed disease progression. The ability to identify a subgroup of patients who may be more responsive to therapy could greatly enhance the clinical use of immune modulators and improve outcomes for those patients. Further analyses with specimens collected from the AbATE study are ongoing to understand the mechanism of response.

Source: EurekAlert!

Genalyte and Barbara Davis Diabetes Center Collaborate to Advance Multiplexed Antigen Panel for Early Diagnosis of Type 1 Diabetes

Genalyte, Inc. recently announced the launch of its Type 1 Diabetes (T1D) antigen panel that runs on the Maverick Detection System. The Genalyte T1D antigen panel is the first multiplexed assay that measures seven autoantibodies associated with the destruction of pancreatic islet cells seen in type 1 diabetes. In a related development, Genalyte reported that it is collaborating with the Barbara Davis Center for Childhood Diabetes (BDC) at the University of Colorado School of Medicine to further develop and test multiplexed antigen panels for the early detection of T1D.

The Genalyte T1D antigen panel was developed as part of the first phase of a Small Business Innovation Research (SBIR) grant awarded to Genalyte to develop multiplexed assays for the early detection and monitoring of type 1 diabetes. The $500,000 grant from the National Institute of Diabetes and Digestive and Kidney Diseases also provides support for expansion of the approach to allow autoantibody response profiling by multiple criteria, which is expected to enhance the ability of researchers and clinicians to detect and monitor the development of the disease.

Martin Gleeson, PhD, Chief Scientific Officer of Genalyte, noted, “The pioneering work of Drs. George Eisenbarth and Liping Yu at BDC established assays for the measurement of islet autoantibodies. These rogue elements of the immune system eventually destroy the pancreatic islet cells that produce insulin. The unique capabilities of our Maverick detection platform have the potential to provide researchers and clinicians with tools to detect and track this process from an early stage, when interventions to interrupt the disease process may be feasible.”

An estimated three million individuals in the U.S. have T1D, an autoimmune disorder that leads to life-long dependence on insulin injections. New disease-modifying therapies may have the potential to reduce or stop the destruction of islet cells in patients at risk of developing T1D. The availability of tools to identify these patients early in the disease process would facilitate the development and use of these preventative therapies.

“We are pleased to offer our innovative T1D antigen panel to diabetes researchers worldwide at the same time that we are working with Dr. Liping Yu and his lab at the Barbara Davis Diabetes Center to expand the utility of the approach,” added Dr. Gleeson. “BDC is a long-time leader in the quest to develop curative therapies for type 1 diabetes, and we are delighted to collaborate with them to develop the tools that may help make this dream a reality.”

The Genalyte T1D antigen panel requires only a 2 to 5 μL serum or plasma sample and provides results in less than 15 minutes, without the use of dyes, fluorescent probes or radioactive labels. The T1D panel measures autoantibodies to insulin, proinsulin, GAD 65, GAD 67, IA-2 (PTPRN, ICA512), phogrin (PTPRN2, IA-2ß) and ZnT8 (SLC30A8). For more information, visit http://genalyte.com/maverick-type-1-diabetes-t1d-assay-kit/.

Other commercially available tests for the Maverick Detection System include MT-ADA, ENA 4, ENA 6 and ANA 14 assay kits. Additionally, Genalyte offers researchers a Custom Spotting Service that loads proteins supplied by customers, such as antibodies, peptides, biomarkers, cytokines and antigens, on to standard-format Genalyte chips that are ready to be run on the Maverick System.

Maverick assays are currently available for research use only.

Source: Genalyte

Metabolon Announces Findings From Two Major Diabetes Outcomes Studies For its Quantose Prediabetes Test

Metabolon, Inc. a pioneering leader of advanced metabolomics, announced outcome results recently from two large-cohort studies evaluating the clinical utility of Quantose, the company’s blood test for prediabetes. The studies provided further evidence that the Quantose test identifies individuals at risk for type 2 diabetes earlier and more accurately than traditional risk factors alone.

The performance of Quantose was measured among 3,841 participants from the Relationship between Insulin Sensitivity and Cardiovascular Disease (RISC) and Botnia Prospective Study cohorts. Notably, among initially healthy participants in the RISC study with 3-year follow-up data:

  • Quantose biomarkers α-hydroxybutyrate (α-HB) and linoleoyl-glycerophosphocholine (L-GPC) independently and significantly predicted worsening glycemic control, and;
  • Quantose outperformed traditional risk measures such as fasting insulin, fasting glucose, BMI, and HOMA-IR in predicting insulin resistance and progression to impaired glucose tolerance.

In the Botnia Prospective Study with 9.5 year follow-up data:

  • Quantose biomarkers were found to predict incident type 2 diabetes independent of familial diabetes, sex, age, BMI, and fasting glucose.

These findings were published in two recent articles:

“Early Metabolic Markers of the Development of Dysglycemia and Type 2 Diabetes and Their Physiological Significance”, Diabetes; Ferrannini, Gall, et.al.; 2013; 62(5): 1730.

“A Novel Fasting Blood Test for Insulin Resistance and Prediabetes” Journal of Diabetes Science and Technology; Ferrannini, Cobb, et.al.; 2013; 7(1): 100.

The Quantose test reflects insulin resistance and detects progression to prediabetes and diabetes earlier than traditional glycemic measures such a hemoglobin A1C. The test is particularly useful in identifying prediabetic patients at greatest risk of disease progression and for whom drug, or other interventional therapy, may be appropriate. Diagnostic assessment with the Quantose test is well-aligned with the American Diabetes Association guidelines which recommend that physicians consider pharmaceutical intervention in high-risk prediabetics.

Beyond its immediate impact on the treatment of prediabetes, Quantose offers convincing evidence of the maturation of the field of metabolomics — and of the potential influence the discovery of novel metabolomic biomarkers will have on personalized medicine. Metabolon is committed to utilizing its systematic metabolomics discovery approach to develop diagnostics in the areas of metabolic, cancer and cardiovascular disease and provide biomarker research services by employing their high-throughput, advanced metabolomics platform.

“These studies are clear affirmation of Quantose value to predict early those individuals at risk for eventual onset of Type 2 diabetes which may provide clinicians the opportunity for treatment interventions that may reverse the prediabetic state.”, Eric Button, Senior Vice President of Diagnostics, Metabolon commented. Eric and other biomarker discovery experts from Metabolon will be present on July 22-24th at the 73rd Scientific Sessions of the American Diabetes Association. Visit booth #776 for more information regarding these studies or schedule an appointment with an expert to learn more about the Quantose test.

Study: Early Metabolic Markers of the Development of Dysglycemia and Type 2 Diabetes and Their Physiological Significance

Study: A Novel Fasting Blood Test for Insulin Resistance and Prediabetes

Source: Metabolon