Efficacy of once-daily, high-dose, oral insulin immunotherapy in children genetically at risk for type 1 diabetes (Primary Oral Insulin Trial (POInT)): a European, randomised, placebo-controlled, primary prevention trial
Primary result · ≥2 islet autoantibodies or diabetesResult — go to the resultHazard ratio 1.12 95% CI 0.76–1.67Authors' conclusion
There was no evidence that high-dose, daily oral insulin prevents the development of islet autoantibodies. Further studies are needed to assess the benefit of primary oral insulin therapy for preventing diabetes in INS genotype-selected infants.
Study context
- Population
- Infants aged 4–7 months with >10% genetic risk of islet autoimmunity, identified by newborn genetic screening at 7 clinics in Germany, Poland, Sweden, Belgium and the UKrandomised 1:1
- Participants
- 1,050 infants
- Comparison
- Daily high-dose oral insulin vs placebo
- Oral insulinn = 528
- Placebon = 522reference
- Primary endpoint
- Development of ≥2 islet autoantibodies or diabetes
- Follow-up
- Throughout until a maximum age of 6.5 years
Methodological detailsplacebo-controlled, primary prevention, multicentre, masked, Excluded from mITT: 2 oral insulin, 0 placebo, Stratified by site; participants, families, investigators and laboratory masked throughout
- Placebo-controlled
- Primary prevention
- Multicentre
- Masked
- Excluded from mITT: 2 oral insulin, 0 placebo
- Stratified by site; participants, families, investigators and laboratory masked throughout
Primary result
≥2 islet autoantibodies or diabetes
Hazard ratio
1.12
95% CI 0.76–1.67
P = 0.57
Events by treatment group
Oral insulinvs Placebo
HR 1.12 (95% CI 0.76–1.67); P = 0.57
As reported in the abstract
Secondary outcomes
| Outcome | Estimate |
|---|---|
| Primary outcome, non-susceptible INS rs1004446 genotypesIncrease with oral insulin | 2.10 (CI 1.08–4.09) |
| Diabetes or dysglycaemia, susceptible INS genotypesProtection with oral insulin | 0.38 (CI 0.17–0.86) |
Primary outcome, non-susceptible INS rs1004446 genotypes
- Interaction between treatment and INS rs1004446 genotype observed
Death
- Deaths in oral insulin group, unrelated to study drug on independent review
- 1
Safety
Blood glucose <50 mg/dL (measurements)
Measurements Oral insulin 7210 · Placebo 7070
Participants with adverse events
Adverse events Oral insulin 5076 · Placebo 5176
- Participants with adverse events — Total reported adverse events
- 10 252
Original publication
Efficacy of once-daily, high-dose, oral insulin immunotherapy in children genetically at risk for type 1 diabetes (POInT): a European, randomised, placebo-controlled, primary prevention trial. Lancet. Published 11 November 2025. doi:10.
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