The aim of this study is to look at the safety of taking insulin by mouth. Pre-POINT wants to find a dose that causes an immune response. This response will hopefully delay or prevent the start of type 1 diabetes. Children who join this study will get insulin or a placebo (dummy drug) by mouth every day for 3 -18 months. Participants will be closely followed for the development of diabetes autoantibodies and type 1 diabetes for the whole study.

Pre-POINT (Primary Oral INsulin Trial) study A dose finding safety and immune efficacy study for primary mucosal insulin therapy in islet autoantibody negative children at high genetic risk for type 1 diabetes - Pre-POINT

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001621-29-DE

Enrollment

Registered

2007-12-07

Start date

2009-05-05

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pre-type 1 diabetes (islet autoimmunity in non-diabetic relatives of subjects with type 1 diabetes)

Interventions

Product Name: human insulin Pharmaceutical Form: Capsule Other descriptive name: oral human insulin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2,5- Pharmaceuti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged 2 years to 7 years who: A. have a multiplex first degree family history of T1DM (both parents, parent and sib, or two sibs); and a type 1 diabetes susceptible HLA DR4-DQB1*0302 or DR4-DQB1*0304 haplotype and none of the following HLA DR or DQB1 alleles: DR 11 DR 12 DQB1*0602 DR7-DQB1*0303 DR14-DQB1*0503 or B. have a sibling with T1DM; and are identical by descent for the HLA DR3/DR4-DQ8 genotype with their diabetic sibling; 2. Islet autoantibody negative at time of recruitment. Are the trial subjects under 18? yes Number of subjects for this age range: 25 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Children with any kind of congenital or acquired chronic disease that potentially interfere with the study objectives. 2. Prior or current participation in another intervention trial. 3. Chronic oral steroid use and/or other chronic oral immunosuppressant

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to determine the feasibility, safety and bioavailability of oral insulin administration in children with high genetic risk for type 1 diabetes (T1DM) in a dose escalation primary intervention pilot study. To find a dose with proven drug bioavailability to the immune system for use in a phase II/III primary T1DM vaccination trial (POINT study) in genetically at risk subjects.;Secondary Objective: na;Primary end point(s): The development of immunity to insulin (IgG or IgA antibodies, or T cell response to insulin and/or insulin peptides).;Timepoint(s) of evaluation of this end point: at baseline visit, Day 15-, 3 Months-, 6 Months-, 12 months- and 18 months of treatment	—

Measure

Time frame

Main Objective: The objective of this study is to determine the feasibility, safety and bioavailability of oral insulin administration in children with high genetic risk for type 1 diabetes (T1DM) in a dose escalation primary intervention pilot study. To find a dose with proven drug bioavailability to the immune system for use in a phase II/III primary T1DM vaccination trial (POINT study) in genetically at risk subjects.;Secondary Objective: na;Primary end point(s): The development of immunity to insulin (IgG or IgA antibodies, or T cell response to insulin and/or insulin peptides).;Timepoint(s) of evaluation of this end point: at baseline visit, Day 15-, 3 Months-, 6 Months-, 12 months- and 18 months of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): na;Timepoint(s) of evaluation of this end point: na	—

Countries

Austria, Germany, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026