Table 2.
Secondary prevention trials in type 1 diabetes (stages 1 and 2)
| Intervention (trial) | Age (years) | Primary endpoint | Status | Clinicaltrials.gov identifier |
|---|---|---|---|---|
| Antigen-specific therapies | ||||
| Parenteral insulin (DPT-1) | 4–45 | T1D onset | Completed | |
| Parenteral insulin (Belgian Diabetes Registry) | 10–23 | T1D onset | Completed | |
| Oral insulin (DPT-1) | 3–45 | T1D onset | Completed; post hoc analysis showed delay in progression to T1D in relatives with insulin autoantibodies ≥80 U/ml | |
| Oral insulin | 3–45 | T1D onset | Follow-up | TrialNet |
| Oral insulin | 3–45 | Change in insulin immune function | Recruiting; open-label dosing and immune mechanism of action study | TrialNet |
| Intranasal insulin (DIPP birth cohort) | 1–5 | T1D onset | Completed; trial stopped after interim analysis showed no effect on T1D progression | |
| Intranasal insulin (DIPP sibling cohort) | 4–11 | T1D onset | Completed; trial stopped after interim analysis showed no effect on T1D progression | |
| Intranasal insulin (INIT-2) | 4–20 | T1D onset | Completed; data collection and analysis | |
| GAD-alum (DiAPREV-IT) | 4–18 | T1D onset | Follow-up | |
| GAD-alum and vitamin D3 (DiAPREV-IT2) | 4–18 | T1D onset | Recruiting | |
| Anti-inflammatory therapies | ||||
| Nicotinamide (DENIS) | 3–12 | T1D onset | Completed | DENIS [42] |
| Nicotinamide (ENDIT) | 5–40 | T1D onset | Completed | ENDIT [41] |
| Immune-modulating therapies | ||||
| CTLA-4 Ig, abatacept | 6–45 | Abnormal glucose tolerance by OGTT | Enrolling | TrialNet |
| Anti-CD3 mAb, teplizumab | 8–45 | T1D onset | Enrolling | TrialNet |
To date, β cell-specific or cell-based therapies have not been used in secondary type 1 diabetes clinical prevention trials