Baseline plasma proinsulin response to glucose for predicting therapeutic response to otelixizumab in recent-onset type 1 diabetes
Authors' conclusion
In recent-onset type 1 diabetes, elevated acutely glucose-stimulated proinsulin may complement or replace acutely or sustainedly stimulated C-peptide release for identifying good responders to anti-CD3, but not as outcome measure.
Study context
- Population
- Patients with recent-onset T1D
- Participants
- 80 patients
- Comparison
- Otelixizumab vs placebo
- Primary endpoint
- Ability of baseline acutely glucose-stimulated proinsulin, C-peptide and PI/CP to predict functional outcome (change in AUC60-140 C-peptide from baseline)
- Follow-up
- 6, 12 and 18 months
Methodological detailsreanalysis of trial data, Hyperglycemic clamps at baseline, 6, 12 and 18 months: 3 h induced euglycemia, then glycemia raised to ≥ 10 mmol/l for 140 min
- Reanalysis of trial data
- Hyperglycemic clamps at baseline, 6, 12 and 18 months: 3 h induced euglycemia, then glycemia raised to ≥ 10 mmol/l for 140 min
Primary result
As reported in the abstract
Prediction of preservation of beta cell function in response to anti-CD3
- Higher baseline (≥median) PI0 independently predicted preservation of beta cell function in response to anti-CD3 (multiple linear regression)
- PI0 interacted significantly with IAA
Further findings
Change in PI/CP0 and PI0 during follow-up
- Anti-CD3 tempered a further increase in PI/CP0, but not in PI0
Post-treatment monitoring
- CP0 outperformed PI0 and PI/CP0 for post-treatment monitoring
Original publication
Baseline plasma proinsulin response to glucose for predicting therapeutic response to otelixizumab in recent-onset type 1 diabetes. Diabetes Res Clin Pract. Published 25 October 2023. doi:10.
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