NCT02620072

Fr1da Insulin Intervention

Completed Phase 2 Last updated 8 October 2024

What this trial tests

Phase 2 trial testing Oral Insulin in Stage 1 Diabetes Mellitus, Type 1 in 220 participants. Completed in 30 September 2024.

Timeline

11 December 2015

Primary endpoint
30 September 2024

30 September 2024

Quick facts

Lead sponsor	Technical University of Munich
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	220
Start date	11 December 2015
Primary completion	30 September 2024
Estimated completion	30 September 2024
Sites	1 location across Germany

Drugs / interventions tested

• Oral Insulin — full drug profile →
• Placebo

Conditions studied

• Stage 1 Diabetes Mellitus, Type 1 — all drugs for Stage 1 Diabetes Mellitus, Type 1 →

Sponsor

Technical University of Munich

Who can join

Adults 2 to 12, any sex, with Stage 1 Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta cells. The process of autoimmune destruction is identified by circulating islet autoantibodies to beta cell antigens, and is mediated by a lack of immunological self-tolerance. Self-tolerance is achieved by T cell exposure to antigen in the thymus or periphery in a manner that deletes autoreactive effector T cells or induces regulatory T cells. Immunological tolerance can be achieved by administration of antigen under appropriate conditions. Evidence is now emerging in humans that these approaches may be effective in chronic inflammatory diseases such as multiple sclerosis and allergy. Administration of oral insulin in multiple islet autoantibody-positive children offers the potential for inducing immunological tolerance to beta cells and thereby protect against further development progression to type 1 diabetes.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Yield of a Public Health Screening of Children for Islet Autoantibodies in Bavaria, Germany.
   Ziegler AG, Kick K, Bonifacio E, Haupt F, et al · · 2020 · cited 193× · PMID 31990315 · DOI 10.1001/jama.2019.21565
2. Progression likelihood score identifies substages of presymptomatic type 1 diabetes in childhood public health screening.
   Weiss A, Zapardiel-Gonzalo J, Voss F, Jolink M, et al · · 2022 · cited 49× · PMID 36028774 · DOI 10.1007/s00125-022-05780-9
3. Current treatment options and challenges in patients with Type 1 diabetes: Pharmacological, technical advances and future perspectives.
   Boscari F, Avogaro A. · · 2021 · cited 39× · PMID 33755854 · DOI 10.1007/s11154-021-09635-3
4. Combination Immunotherapy for Type 1 Diabetes.
   Bone RN, Evans-Molina C. · · 2017 · cited 30× · PMID 28534310 · DOI 10.1007/s11892-017-0878-z
5. Immunotherapy Strategies for the Prevention and Treatment of Distinct Stages of Type 1 Diabetes: An Overview.
   Rapini N, Schiaffini R, Fierabracci A. · · 2020 · cited 19× · PMID 32204344 · DOI 10.3390/ijms21062103
6. Screening and Prevention of Type 1 Diabetes: Where Are We?
   Simmons KM, Sims EK. · · 2023 · cited 17× · PMID 37290044 · DOI 10.1210/clinem/dgad328
7. Delivery route considerations for designing antigen-specific biomaterial strategies to combat autoimmunity.
   Ackun-Farmmer MA, Jewell CM. · · 2023 · cited 15× · PMID 36938103 · DOI 10.1002/anbr.202200135
8. The Development of Immunotherapy Strategies for the Treatment of Type 1 Diabetes.
   Coppieters K, von Herrath M. · · 2018 · cited 13× · PMID 30356664 · DOI 10.3389/fmed.2018.00283