Fall in C-peptide during first 2 years from diagnosis: Evidence of at least two distinct phases from composite type 1 diabetes trialnet data

Carla J. Greenbaum, Craig A. Beam, David Boulware, Stephen E. Gitelman, Peter A. Gottlieb, Kevan C. Herold, John M. Lachin, Paula McGee, Jerry P. Palmer, Mark D. Pescovitz, Heidi Krause-Steinrauf, Jay S. Skyler, Jay M. Sosenko

Research output: Contribution to journalArticlepeer-review

188 Scopus citations

Abstract

Interpretation of clinical trials to alter the decline in β-cell function after diagnosis of type 1 diabetes depends on a robust understanding of the natural history of disease. Combining data from the Type 1 Diabetes TrialNet studies, we describe the natural history of β-cell function from shortly after diagnosis through 2 years post study randomization, assess the degree of variability between patients, and investigate factors that may be related to C-peptide preservation or loss. We found that 93% of individuals have detectable C-peptide 2 years from diagnosis. In 11% of subjects, there was no significant fall from baseline by 2 years. There was a biphasic decline in C-peptide; the C-peptide slope was -0.0245 pmol/mL/month (95% CI -0.0271 to -0.0215) through the first 12 months and -0.0079 (-0.0113 to -0.0050) from 12 to 24 months (P < 0.001). This pattern of fall in C-peptide over time has implications for understanding trial results in which effects of therapy are most pronounced early and raises the possibility that there are time-dependent differences in pathophysiology. The robust data on the C-peptide obtained under clinical trial conditions should be used in planning and interpretation of clinical trials.

Original languageEnglish (US)
Pages (from-to)2066-2073
Number of pages8
JournalDiabetes
Volume61
Issue number8
DOIs
StatePublished - Aug 2012

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

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