October 11, 2018
The American Diabetes Association (ADA), JDRF International (JDRF) and The Leona M. and Harry B. Helmsley Charitable Trust (Helmsley) together announce the awarding of funding to the University of Florida for a one-year investigation by Dr. Timothy Garrett of the consistency and potency of insulin that is purchased at retail pharmacies across the United States.
This effort was prompted by a small study published in the December 2017 edition of the
Journal of Diabetes Science and Technology, by Carter and Heinemann¹. The study, which was not initiated or supported by JDRF, the ADA or Helmsley, found a wide variation in the level of activity in insulin available at U.S. pharmacies.
Carter and Heinemann examined 18 10-mL vials of NPH and regular insulin produced by two major manufacturers and randomly purchased in U.S. pharmacies. It found an average dosage of 40.2 U/mL with levels ranging from 13.9 to 94.2 U/mL. None of the vials met the 95-U/mL standard at the time of testing. The U.S. Pharmacopeia and the U.S. Food and Drug Administration require insulin vials and cartridges to contain a minimum of 95 percent intact insulin (95 U/mL).
Their report raised concerns among people with diabetes and health care providers, and controversy among manufacturers, clinicians and biochemists because the study’s findings were inconsistent with data from previous regulatory audits, as well as detailed checks and balances from manufacturers. Dr. Garrett’s research will help identify and assess the potential for insulin degradation across a wide range of formulas.
“Insulin activity is of utmost importance to the diabetes community,’’ he said. “In collaboration with Insulin for Life, we have designed a comprehensive measurement approach that incorporates standard methods for quality assessment, along with new methods that taken together will provide the best assessment of insulin activity for the patient.”
The University of Florida-based investigation team, led by Garrett and consisting of internationally recognized experts, will examine eight insulin formulations that vary on time-action profiles, across five U.S. regions, for 12-months, and using multiple potency testing methodologies. The results of their work will be published by mid-2019.
“The December 2017 study shed light on an issue that affects millions of insulin-dependent Americans,” said Sanjoy Dutta, JDRF Assistant Vice President of Research. “Along with our partners at the ADA and the Helmsley Charitable Trust, we are confident that Dr. Garrett and his team will help to accurately analyze the quality of insulin at the point of sale to ease the concerns of our community.”
“We look forward to Dr. Garrett and his team’s findings to help us clarify the findings of Carter and Heinemann’s study. With this information, we hope to bring peace of mind to the millions of people with diabetes who rely on insulin every day,” said ADA’s Chief Scientific, Medical and Mission Officer William T. Cefalu, MD. “Patients and their loved ones should not have to worry about whether or not the insulin at their local pharmacies will be effective. The ADA is grateful for the collaboration and support of JDRF and Helmsley to help make this research possible.”
“Dr. Garrett’s investigation aligns with our long-term goal of improving the lives of people with type 1 diabetes,” said Sean Sullivan, PhD, Helmsley Type 1 Diabetes Program Officer. “Daily management of this disease is time-consuming, complex, and challenging. It is critical for those living with this disease to know the quality of their insulin and we are confident this rigorous study will allow that. We are happy to partner with ADA and JDRF to fund this effort.”
1. Carter, AW and Heinemann, L. Insulin Concentration in Vials Randomly Purchased in Pharmacies in the United States: Considerable Loss in the Cold Supply Chain. Journal of Diabetes Science and Technology. https://doi.org/10.1177/1932296817747292
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About the American Diabetes Association
Nearly half of American adults have diabetes or prediabetes; more than 30 million adults and children have diabetes; and every 21 seconds, another individual is diagnosed with diabetes in the U.S. Founded in 1940, the American Diabetes Association (ADA) is the nation’s leading voluntary health organization whose mission is to prevent and cure diabetes, and to improve the lives of all people affected by diabetes. The ADA drives discovery by funding research to treat, manage and prevent all types of diabetes, as well as to search for cures; raises voice to the urgency of the diabetes epidemic; and works to safeguard policies and programs that protect people with diabetes. In addition, the ADA supports people living with diabetes, those at risk of developing diabetes, and the health care professionals who serve them through information and programs that can improve health outcomes and quality of life. For more information, please call the ADA at 1-800-DIABETES (1-800-342-2383) or visit diabetes.org. Information from both of these sources is available in English and Spanish. Find us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).
About the JDRF
JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.
About the Helmsley Charitable Trust
The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Since beginning active grantmaking in 2008, Helmsley has committed more than $2 billion for a wide range of charitable purposes. For more information, visit www.helmsleytrust.org.