Background & Purpose

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PURPOSE

JDRF International, American Diabetes Association, and The Leona M. and Harry B. Helmsley Charitable Trust (Helmsley) are requesting proposals from analytical laboratories based in the United States (US) to analyze insulin activity in vials and pen cartridges that will be purchased from retail pharmacies in diverse locations throughout the US.

BACKGROUND

In December 2017, data published online by Alan W Carter, Pharm. D., of MRI Global and the University of Missouri–Kansas City, and Lutz Heinemann, Ph.D., of Science & Co, Düsseldorf, Germany in the Journal of Diabetes Science and Technology, found that the average amount in 18 10-mL vials of NPH and regular insulin from the two major manufacturers was 40.2 U/mL, ranging from 13.9 to 94.2 U/mL. None met the 95-U/mL standard at the time of testing. This data was based on analysis of insulin vials randomly purchased in US pharmacies. However, the standards established by the US Pharmacopeia and Food and Drug Administration (FDA) require that insulin vials and cartridges contain a minimum of 95% intact insulin (95 U/mL).

This report has generated considerable concern among insulin users and has generated controversy among manufacturers, clinicians, and biochemists. A larger study is needed to further investigate and verify the findings from this study.