Primary prevention of type 1 diabetes in very young children at high risk for type 1 diabetes using oral insulin

- PRE-POINT-EARLY STUDY - Pilot study using oral insulin at early age for immune efficacy in primary prevention of type 1 diabetes - Pre-POINT Early Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005287-15-DE

Enrollment

Registered

2015-04-13

Start date

2015-07-15

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Risk for type 1 diabetes

Interventions

Product Name: insulin human Pharmaceutical Form: Capsule, hard INN or Proposed INN: INSULIN HUMAN CAS Number: 11061-68-0 Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged 6 months to 2 years who have a first degree relative with type 1 diabetes, and have a HLA genotype that includes a HLA DR4-DQB1*0302 or HLA DR4-DQB1*0304 haplotype, and does not include one of the following alleles or haplotypes: DR 11, DR 12, DQB1*0602, DR7-DQB1*0303, DR14-DQB1*0503 and must be 2. Islet autoantibody negative at time of recruitment. Are the trial subjects under 18? yes Number of subjects for this age range: 44 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. Concomitant disease or treatment, which may interfere with assessment or cause immunosuppression, as judged by the investigators. 2. Prior or current participation in another intervention trial. 3. Any condition that could be associated with poor compliance.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether daily administration of up to 67.5 mg insulin to young children aged 6 months to 2 years with high genetic risk for T1D induces immune responses to insulin with features of immune regulation.; Secondary Objective: To determine whether daily administration of up to 67.5 mg insulin induces metabolic changes in blood (glucose, insulin and C-peptide levels) of safety concern in infants aged 6 months to 2 years. To determine whether daily administration of up to 67.5 mg insulin to young children aged 6 months to 2 years with high genetic risk for T1D induces immune responses to proinsulin. ;Primary end point(s): GAD, IA-2, or ZnT8 autoantibody positivity in two consecutive samples or diabetes;Timepoint(s) of evaluation of this end point: at abseline, 3 months-, 6 months-, 9 months- and 12 months of treatment	—

Measure

Time frame

Main Objective: To determine whether daily administration of up to 67.5 mg insulin to young children aged 6 months to 2 years with high genetic risk for T1D induces immune responses to insulin with features of immune regulation.; Secondary Objective: To determine whether daily administration of up to 67.5 mg insulin induces metabolic changes in blood (glucose, insulin and C-peptide levels) of safety concern in infants aged 6 months to 2 years. To determine whether daily administration of up to 67.5 mg insulin to young children aged 6 months to 2 years with high genetic risk for T1D induces immune responses to proinsulin. ;Primary end point(s): GAD, IA-2, or ZnT8 autoantibody positivity in two consecutive samples or diabetes;Timepoint(s) of evaluation of this end point: at abseline, 3 months-, 6 months-, 9 months- and 12 months of treatment

—

Secondary

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

Countries

Germany

Contacts

Public ContactProf. Dr. Anette-G. Ziegler

Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München

anette-g.ziegler@helmholtz-muenchen.de+498931872896

Outcome results

None listed

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