C-peptide and metabolic outcomes in trials of disease modifying therapy in new-onset type 1 diabetes: an individual participant meta-analysis
An erratum to this article was published (Lancet Diabetes Endocrinol, Feb 2024 ↗)
Authors' conclusion
Interventions that preserve β-cell function are effective at improving metabolic outcomes in new-onset type 1 diabetes, confirming their potential as adjuncts to insulin. We have shown that improvements in HbA1c are directly proportional to the degree of C-peptide preservation, quantifying this relationship, and supporting the use of C-peptides as a surrogate endpoint in clinical trials.
Study context
- Population
- New-onset T1D; 1315 adults (≥18 years) and 1396 children (<18 years)21 trials
- Comparison
- Active disease-modifying therapy vs control
- Outcome
- HbA1c vs C-peptide preservation
- Follow-up
- 6 months
Methodological details21 trials, disease-modifying interventions within 100 days of diagnosis, Differences between active and control groups assessed with Wilcoxon rank test
- 21 trials
- Disease-modifying interventions within 100 days of diagnosis
- Differences between active and control groups assessed with Wilcoxon rank test
Pooled result
As reported in the abstract
Positive studies: 24.8% greater C-peptide preservation associated with lower HbA1c (p<0.0001); detectable as early as 3 months
0.55%
Cross-sectional (positive and negative studies): 55% improvement in C-peptide preservation associated with lower HbA1c (p<0.0001)
0.64%
Further pooled results
Predictors of HbA1c improvement
- Higher initial C-peptide and greater preservation associated with greater HbA1c improvement
Sample size for HbA1c, IDAAC and BETA-2 score vs C-peptide · 6 months
- Participants per group required relative to C-peptide
- 2-3 times as many
Safety
- Detecting a reduction in hypoglycaemia was affected by reporting methods
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
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