Two clinical investigators from the Jacobs School of Medicine and Biomedical Sciences at the University of Buffalo (UB) participated in a successful worldwide Novo Nordisk-sponsored clinical trial, confirming that a fast-acting insulin is safe for children with diabetes mellitus. The sponsor selected UB due to their experience, research support levels, and track record for recruiting and retaining patients, which ultimately is made possible by the hard work of the research teams, including the coordinators.
The Study Leads to FDA Approval
The Novo Nordisk-sponsored clinical trial spanned 17 countries and ultimately included more than 700 children nationwide. The study results contributed to the approval of the drug by the U.S. Food and Drug Administration (FDA) on Dec. 19, 2019.
Called the “onset 7” trial, Novo Nordisk sponsored this global trial to investigate the efficacy and safety of faster-acting insulin aspart (Fiasp®) compared to NovoRapid both in combination with insulin degludec in children and adolescents with type 1 diabetes. UB reports the study included 150 sites in 17 countries participating worldwide in the study. UB was able to recruit and ...
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