Bethesda, MD — The use of adiponectin, a hormone derived from fat cells, which is abundant in plasma and easy to measure through commercially available kits, was confirmed as a robust biomarker predictive of glycemic efficacy in Type 2 diabetes and healthy subjects, after treatment with peroxisome proliferator-activated receptor-agonists (PPAR), but not after treatment with non-PPAR drugs such as metformin. The findings were the result of the first project to be completed by the Biomarkers Consortium, a public-private partnership managed by the Foundation for the National Institutes of Health. The project conducted a statistical analysis of pooled and blinded pre-existing data from Phase II clinical trials contributed by four pharmaceutical companies and analyzed under the direction of a diverse team of scientists from industry, the National Institutes of Health (NIH), U.S. Food & Drug Administration (FDA), and academic research institutions.
"The Consortium’s ability to combine significant trial data from multiple pharmaceutical companies with analytical and scientific expertise from public and private sector partners from across the biomedical research community was critical to the success of this study, and may lead to new approaches to develop therapies for people with Type 2 diabetes," said Charles Sanders, M.D., Chairman of the Foundation for NIH. "This project demonstrates that cross-company collaboration is a robust, feasible, and powerful approach to qualifying biomarkers."
Type 2 diabetes accounts for more than 90% of all diabetes and affects 5.1% of adults globally. It is estimated to reach 330 million cases by 2030. Adiponectin is a hormone found in the body that modulates a number of metabolic processes, including glucose regulation and fatty acid catabolism. Currently, an existing biomarker, hemoglobin A1C (HbA1C), is the standard way of assessing a patient’s glycemic response to diabetes drugs, but in order to determine whether or not a treatment is effective for a patient with Type 2 Diabetes, it takes as much as three months to detect changes in HbA1C in response to changes in fasting glucose levels. The results of the Biomarkers Consortium’s study suggest that adiponectin can predict glycemic response in as little as six weeks and across the spectrum of glucose tolerance.
The project pooled blinded data from existing completed clinical trials contributed by Eli Lilly and Company, GlaxoSmithKline, Hoffmann-LaRoche, Inc, and Merck Research Laboratories into a single database hosted by Quintiles Transnational Corporation. For quality control purposes, two separate statisticians—one from Quintiles and the other from the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) at NIH—analyzed the data in parallel under the supervision of a multi-institutional Project Team led by Dr. John Wagner, Vice President of Clinical Pharmacology at Merck. The results of the analysis were recently presented at the 69th Scientific Session of the American Diabetes Association this June and have just been published in Clinical Pharmacology and Therapeutics Online.
Dr. Wagner summarized the findings of the study: "Our pre-competitive collaboration concluded that adiponectin could serve as a diagnostic biomarker to predict how patients will respond to thiazolidinediones, a commonly used drug in the treatment to T2D, and furthermore demonstrated the value of an inclusive, truly open source approach to biomarker research."
The Biomarkers Consortium endeavors to develop, validate, and qualify biological markers (biomarkers) to speed the development of medicines and therapies for detection, prevention, diagnosis, and treatment of disease and improve patient care. The Consortium currently has 60 members, including FDA, NIH, and PhRMA, and is managed by the FNIH. The adiponectin project was initially conceived and launched by the Consortium’s Metabolic Disorders Steering Committee, which is co-chaired by Dr. Myrlene Staten of NIDDK and Dr. Bjorn Carlsson from AstraZeneca.
# # #
About the Foundation for NIH
Established by the United States Congress to support the mission of the NIH—improving health through scientific discovery in the search for cures—the Foundation for NIH is a leader in identifying and addressing complex scientific and health issues. The foundation is a non-profit, 501(c)(3) charitable organization that raises private-sector funds for a broad portfolio of unique programs that complement and enhance NIH priorities and activities. For additional information about the Foundation for NIH, please visit www.fnih.org.
About the Biomarkers Consortium
The Biomarkers Consortium is a public-private biomedical research partnership managed by the Foundation for the National Institutes of Health that endeavors to discover, develop, and seek regulatory approval for biological markers (biomarkers) to speed the development of medicines and therapies for detection, prevention, diagnosis and treatment of disease and improve patient care. For additional information about the Biomarkers Consortium, please visit www.biomarkersconsortium.org.