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

An immune efficacy study for primary prevention using intranasal insulin therapy in islet autoantibody negative children at high genetic risk for type 1 diabetes - PINIT Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003379-31-DE

Enrollment

Registered

2016-09-02

Start date

2017-01-31

Completion date

Unknown

Last updated

2022-03-14

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: intranasal insulin Pharmaceutical Form: Nasal spray, solution INN or Proposed INN: INSULIN HUMAN CAS Number: 11061-68-0 Concentration unit: mg/ml milligram(s)/millilitre Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent signed by either both parents or legal guardian(s). 2. Children aged 1 year to 7 years (randomization must be performed prior to 8th birthday) who: a. have the HLA DR3-DQB1*0201/DR4-DQB1*0302 or HLA DR3-DQB1*0201/DR4-DQB1*0304 genotype or b. 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: DR11, DR12, DQB1*0602, or haplotypes: DR7-DQB1*0303, DR14-DQB1*0503, DR13-DQB1*0603 and 3. are islet autoantibody negative (autoantibodies against insulin, GAD, IA-2 and ZnT8) at the time of screening (time between screening sample collection and randomization must not exceed 90 days). Are the trial subjects under 18? yes Number of subjects for this age range: 38 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: Participants meeting any of the following criteria will NOT be eligible for inclusion into the study: 1. Concomitant disease or treatment that may interfere with assessment or cause immunosuppression, as judged by the investigators. 2. Any condition that could be associated with poor compliance. 3. Any defect or pathology of nasal passage that would preclude application of the intranasal spray. 4. Any moderate to severe intolerance to ingredients of the investigational medicinal product.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether intranasal administration of 440 IU insulin to children with high genetic risk for T1D will induce likely protective IgG or IgA antibody responses to insulin, and/or T-cell responses to insulin and/or proinsulin.;Secondary Objective: not applicable;Primary end point(s): the activation of an immune response (antibody or CD4+ T cell) against insulin;Timepoint(s) of evaluation of this end point: at baseline, month 3 and month 6	—

Measure

Time frame

Main Objective: To determine whether intranasal administration of 440 IU insulin to children with high genetic risk for T1D will induce likely protective IgG or IgA antibody responses to insulin, and/or T-cell responses to insulin and/or proinsulin.;Secondary Objective: not applicable;Primary end point(s): the activation of an immune response (antibody or CD4+ T cell) against insulin;Timepoint(s) of evaluation of this end point: at baseline, month 3 and month 6

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Germany

Contacts

Public ContactPD Dr. med. Peter Achenbach

Forschergruppe Diabetes, Klinikum Rechts der Isar, Technische Universität München

peter.achenbach@helmholtz-muenchen.de00498931872896

Outcome results

None listed

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