Unknown

Dataset Information

0

Fall in C-peptide during first 2 years from diagnosis: evidence of at least two distinct phases from composite Type 1 Diabetes TrialNet data.


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.

SUBMITTER: Greenbaum CJ 

PROVIDER: S-EPMC3402330 | biostudies-literature |

REPOSITORIES: biostudies-literature

Similar Datasets

| S-EPMC5033079 | biostudies-other
| S-EPMC6027962 | biostudies-literature
| S-EPMC9394628 | biostudies-literature
| S-EPMC5440274 | biostudies-literature
| S-EPMC4906386 | biostudies-other
| S-EPMC136508 | biostudies-literature
| S-EPMC3112016 | biostudies-literature
| S-EPMC7979771 | biostudies-literature
| S-EPMC4917434 | biostudies-literature
| S-EPMC7018715 | biostudies-literature