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Evidence for C-Peptide as a Validated Surrogate to Predict Clinical Benefits in Trials of Disease-Modifying Therapies

Esther Latres1, Carla J Greenbaum2, Maria L Oyaski1

  • 1JDRF, New York, NY.

Diabetes
|February 13, 2024
PubMed

Insights

C-peptide, a biomarker of pancreatic beta-cell function, can predict clinical benefits in type 1 diabetes. Validating C-peptide as an outcome measure would accelerate the development of new disease-modifying therapies.

Area of Science:

  • Endocrinology
  • Immunology
  • Metabolic Diseases

Background:

  • Type 1 diabetes (T1D) involves autoimmune destruction of pancreatic beta-cells, leading to metabolic dysregulation.
  • Current clinical outcome measures hinder the development of novel T1D therapies.
  • C-peptide, a byproduct of insulin processing, reflects beta-cell function and is measurable in peripheral blood.

Purpose of the Study:

  • To evaluate C-peptide as a quantitative biomarker for beta-cell function in T1D.
  • To establish C-peptide's role as a clinically meaningful outcome measure for T1D clinical trials.
  • To advocate for regulatory acceptance of C-peptide as a surrogate endpoint.

Main Methods:

  • Review of studies correlating stimulated C-peptide levels with clinical benefits in T1D.
  • Analysis of prospective cohort studies and islet transplantation trials.
  • Assessment of C-peptide's characteristics: specificity, sensitivity, feasibility, and clinical relevance.

Main Results:

  • Stimulated C-peptide levels correlate with clinical benefits and glycemic control in T1D.
  • Higher C-peptide levels at diagnosis are associated with protection from diabetes complications.
  • Even lower C-peptide levels offer protection against severe hypoglycemia in T1D.

Conclusions:

  • C-peptide is a valuable biomarker for assessing beta-cell preservation or restoration in T1D.
  • Regulatory validation of C-peptide as a surrogate endpoint would significantly advance T1D therapy development.
  • Utilizing C-peptide can streamline clinical trials for disease-modifying T1D treatments.

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