Clinical investigators from University of Buffalo, UBMD Pediatrics and Oishei Children’s Hospital, not to mention some committed Western New York families, contributed valuable support so that the Food and Drug Administration (FDA) could approve a fast-acting insulin for children with diabetes mellitus.

A Novo Nordisk Clinical Trial

A Novo Nordisk clinical trial spanned 17 countries and ultimately more than 700 children worldwide. The study was led in Buffalo by clinical professional Kathleen E. Bethin, Department of Pediatrics in the Jacobs School of Medicine and Biomedical Sciences at UB, and physician with UBMD Pediatrics and the Diabetes Center at UBMD Pediatrics, and Oishei Children’s Hospital (OCH).

The successful trial made the fast-acting insulin called Fias® (insulin aspart injection) 100 u/mL, which was approved for adult use in 2017, available for children as young as 2 years old.

What is Fiasp?

Known as insulin aspart, and sold under the brand name Novolog among others, is a type of manufactured insulin used to treat type I and type II diabetes. Typically, it is taken prior to eating and generally used under the skin but also may be used by injection into a vein. Maximum effect occurs after about 1-3 hours and lasts for 3.5 hours. Generally, a long-acting insulin like NPH is also needed. Side reports are associated with the label

The Study

UB was invited by Novo Nordisk researchers to participate, they reported, as a result of the UB team’s excellent reputation for conducting and completing clinical trials. The study included 150 sites in 17 countries, so each was small and labor-intensive, reports UBNow. In the Buffalo study, five children aged 13 to 17 participated at UBMD Pediatrics in the Conventus medical office building. A key underlying forcer in the approval was the support of the Jacobs School and UB’s Clinical and Translational Science Institute (CTSI). And collaboration with providers such as OCH was key.

Comments

Lucy D. Mastrandrea commented, “The goal in the diabetes field is to develop insulin analogs that behave more like natural insulin, which is rapid on, rapid off, meaning its quickly released, then quickly dissipates,” and also noted, “Part of the reason this this drug was developed was to have a better timeline of action that’s closer to natural insulin.” She added that having the Jacobs School, UBMD Pediatrics and OCH on one campus downtown delivers additional advantages. Mastrandrea reports, “We have a wonderful collaboration with Kaleida.  Our patients receive state-of-the-art-care because of the research we do.” 

Lead Research/Investigator

Kathleen E. Bethin, Department of Pediatrics in the Jacobs School of Medicine and Biomedical Sciences at UB

Lucy D. Mastrandrea, associate professor and division chief, Endocrinology/Diabetes in the Department of Pediatrics and medical director of the Diabetes Center

Source: University of Buffalo

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