The study examined the potency and consistency of active insulin in products available across the United States
NEW YORK, May 11, 2020 — Breakthrough T1D, the American Diabetes Association (ADA), and The Leona M. and Harry B. Helmsley Charitable Trust, announce the results of a study examining the consistency and potency of insulin purchased at U.S. retail pharmacies. The study, led by University of Florida researcher Timothy Garrett and published in Diabetes Care found all human and analog insulins measured contained the expected quantity of active insulin.
Insulin is a life-saving drug for people with diabetes that can be dangerous and potentially fatal when incorrectly dosed. Variation in insulin activity or insufficient insulin activity would pose significant challenges and safety risks for people with diabetes attempting to manage their blood glucose levels.
“During such an unprecedented time it’s more important than ever for people with T1D to feel safe. This study reaffirms our confidence in the safety and effectiveness of insulin products,” said Aaron Kowalski, Ph.D., president and CEO of Breakthrough T1D. “As Breakthrough T1D, our partners, and the type 1 diabetes community pursue cures and support the development of better insulins, we must also work together to make these safe and effective insulin products affordable and accessible to everyone who needs them.”
In April 2018, Breakthrough T1D, ADA, and Helmsley issued a request for proposals (RFP) to study insulin potency and consistency, which was prompted by a small study published in 2017 that found variation in the level of active insulin in products available commercially in the United States. Notably, this 2017 study did not use a research method approved by the U.S. Pharmacopeia (USP) and was inconsistent with data from previous regulatory audits. To research the issue further, Breakthrough T1D, ADA, and Helmsley supported a team that devised an unbiased, well-powered, and independent assessment of insulin products from major manufacturers using approved USP methods.
USP and the U.S. Food and Drug Administration require insulin vials and cartridges to contain 100 U/mL (± 5 U/mL).
This single year of research will be expanded during a second study phase to measure any potential seasonal variations in reported insulin activity.
About Breakthrough T1D
JDRF’s mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, Breakthrough T1D 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 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.
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 $2.5 billion for a wide range of charitable purposes. The Helmsley Type 1 Diabetes Program is the one of the largest private foundation funders of T1D in the nation focused on understanding the disease, developing better treatments, and improving care and access. For more information on Helmsley and its programs, visit helmsleytrust.org.
