( MENAFN - PR Newswire) C-peptide, a biomarker that indicates insulin production, is a validated surrogate endpoint in type 1 diabetes clinical trials NEW YORK, May 20, 2024 /PRNewswire/ -- A paper published in the June edition of the Journal Diabetes demonstrates that C-peptide, a biomarker that indicates the production of insulin, is a validated surrogate endpoint, or predictor of clinical benefit, for clinical trials of disease-modifying therapies for type 1 diabetes (T1D) in the new-onset stage. The paper, written by JDRF Vice President of Research Esther Latres, Ph.D.
, and co-authored by JDRF staff and other leaders in the field, reviewed published evidence and clearly demonstrated the association between the preservation of C-peptide and clinical benefits. If accepted by the regulators, the use of C-peptide as a validated endpoint has the potential to transform T1D clinical trials and accelerate the development of disease-modifying therapies for T1D. "Through a comprehensive and extensive review of studies showing clinical benefits and endpoints traditionally used in type 1 diabetes, there is support for the acceptance of stimulated C-peptide as a validated surrogate endpoint for clinical trials in disease-modifying therapies in people with newly diagnosed type 1 diabetes," said Esther Latres, JDRF Vice President of Research.
"There remains an urgent need for new therapies that can change the course of T1D, particularly in its early stages. Such acceptance would be a br.