PINIT Study: Primary Intranasal Insulin Trial

Plain-language summary

This study examined, compared with placebo, whether insulin given into the nose could help prevent type 1 diabetes in young children at high genetic risk. It enrolled children aged 1 to 7 who carried certain high-risk HLA genotypes or had a first-degree relative with type 1 diabetes. It was carried out in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Technical University of Munich

Intervention

intranasal insulin, Placebo

Start date

5/25/2018

Estimated completion

6/7/2021

Countries

Germany

Related genes

Locations

• Dresden, Germany
• München, Germany

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Children aged 1 year to 7 years (randomization must be performed prior to 8th birthday) who

   * have the HLA DR3-DQB1\*0201/DR4-DQB1\*0302 or the HLA DR3-DQB1\*0201/DR4-DQB1\*0304 genotype or
   * have a first degree relative with type 1 diabetes, and have a HLA genotype that includes the HLA DR4-DQB1\*0302 or HLA DR4-DQB1\*0304 haplotype, and does not include one of the following alleles DR 11, DR 12, DQB1\*0602, or haplotypes DR7-DQB1\*0303, DR14-DQB1\*0503, DR13-DQB1\*0603 and must be
2. Islet autoantibody negative (autoantibodies against insulin, GAD, IA-2 and ZnT8) at time of screening.

Exclusion Criteria:

1. Concomitant disease or treatment, which 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, which would preclude application of the intranasal spray.
4. Any moderate to severe intolerance to ingredients of the investigational medicinal product.