Chicago, Illinois - 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.”