NCT02620072CompletedPhase 2
Fr1da Insulin Intervention
Mechanistic Study Using Oral Insulin for Immune Efficacy in Secondary Prevention of Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 8 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 220 (actual)
- First submitted
- 29 Nov 2015
- Start date
- 11 Dec 2015
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Technical University of Munich
- Diseases
- Type 1 diabetes
- NCT number
- NCT02620072
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 220
- From 11 Dec 2015 to the primary completion date, 30 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant disease or treatment that may interfere with assessment or cause immunosuppression, as judged by the investigators.
Other illness
- dysglycaemia or overt hyperglycemia (diabetes)
- Any condition that could be associated with poor compliance.
Other
- Participants meeting any of the following criteria will NOT be eligible for inclusion into the study:
- Current participation in another intervention trial.
Who the study is looking for
- Written informed consent signed by either parent(s) or legal guardian(s).
- Children aged 2 years to 12 years.
- Positive for at least two islet autoantibodies out of autoantibodies to glutamic acid decarboxylase (GAD65), to insulin (IAA), autoantibodies to IA-2 (IA2A), or autoantibodies to zink transporter 8 (ZnT8A) (time between screening sample collection and randomization must not exceed 90 days).
- Normoglycemia assessed by oral glucose tolerance test (OGTT).
- Participation in an observational study that regularly monitors diabetes development
Age in the registry: 2 years to 12 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Lehrstuhl für Diabetes und Gestationsdiabetes, der Technischen Universität München Coordinator of this site? Confirm its status | München | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.