PINIT Study: Primary Intranasal Insulin Trial

• Status: Completed
• Trial end date: 2021-06-07
• Target enrollment: 0
• Participant gender: All

Summary

Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta cells. Administration of mucosal insulin in islet autoantibody-negative children who are genetically predisposed for T1D offers the potential for inducing immunological tolerance to beta cells and thereby protect against the development of islet autoimmunity and T1D. Intranasal insulin has the advantage that whole protein will be exposed at the mucosa. Therefore, the available dose of insulin when administered intranasally is likely to be consistent between individuals. On this basis, the investigators aim to conduct a placebo-controlled, double-blind/double-masked primary intervention pilot trial (PINIT Study) of intranasal insulin treatment in islet autoantibody negative children to test immune efficacy and safety in the primary prevention setting. This pilot will help to develop and design a Phase III study aiming to test efficacy of preventing islet autoimmunity and T1D.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Technische Universität München
• Collaborators: Helmholtz Zentrum München; Ludwig-Maximilians - University of Munich; Technische Universität Dresden; University Hospital Carl Gustav Carus
• Treatments: Benzalkonium Compounds; Insulin; Insulin, Globin Zinc

Criteria

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.