pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
Studies on primary and secondary prevention of T1D
| Drug | Study | Population, age (years) | Time of diagnosis | Intervention | Primary outcome | Outcome ( |
|---|---|---|---|---|---|---|
| Insulin-free whey-based formula | FINDIA27) | n=1104, birth | n/a | Whey-based FINDIA formula essentially free of bovine insulin | Acquisition of autoimmunity | OR: 0.39 (0.01) |
| Casein hydrolysate formula | TRIGR29) | n=2159, birth | n/a | Casein hydrolysate formula until 6 months of age or least 60 days but not beyond 8 months of age | Diagnosis of T1D | HR: 1.1 (0.46) |
| Delayed gluten exposure | BABYDIET30) | n=150, birth | n/a | Control group: gluten introduction at the age of 6 months Late-exposure group: delay gluten introduction until the age of 12 months | Acquisition of autoimmunity | HR: 1.3 (0.6) |
| Oral insulin | GPPAD-03 POInT32) | n=25, 2-7 | n/a | Oral insulin 7.5 mg/day vs. 22.5 mg/day vs. 67.5 mg/day vs. placebo for 2 months | Acquisition of autoimmunity or diagnosis of T1D | In progress |
| Oral insulin | TrialNet Oral Insulin34) | n=389, 3-45 | n/a | Oral insulin 7.5 mg/day | Diagnosis of T1D | HR: 0.87 (0.21) |
| Abatacept (anti-CD80/86) | TrialNet abatacept41) | n=212, 6-45 | <6 months |
Total 14 IV infusions at week 0, 2, 4, then every 28±7 days for 12 months | Diagnosis of T1D | HR: 0.702 (0.11) |
| Teplizumab (anti-CD3) | TrialNet teplizumab7) | n=76, 8-45 | <6 months |
IV infusion for 14 days day 0: 51 μg/m2; day 1: 103 μg/m2; day 2: 207 μg/m2; day 3: 413 μg/m2; day 4-13: 826 μg/m2 | Diagnosis of T1D | HR: 0.41 (95% CI: 0.22-0.78) |
*Time after diagnosis of stage 1. Abbreviations: HR, hazard ratio; IV, intravenous; n/a, not applicable; OR, odds ratio; T1D, type 1 diabetes