Primary Oral Insulin Trial

Overview

Overview
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SEEK ID: https://ldh-dzkj.vm.gwdguser.de/projects/8

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Project created: 13th Jul 2026

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : NCT03364868

Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : Oral Insulin Therapy for Prevention of Autoimmune Diabetes
Language of the title/name : English

Title/name : GPPAD-POInT (Global Platform of Autoimmune Diabetes - Primary Oral Insulin Trial)
Language of the title/name : English

Acronym(s) of the Project

Acronym : POInT
Language of the acronym : English

Description(s) of the Project

Description : The GPPAD-POInT-Study aims to determine whether daily administration of oral insulin to children from age 4 months - 7 months with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies and diabetes in childhood. The purpose of the GPPAD-POInT-Study is to induce immune tolerance to beta-cell autoantigens through regular exposure to oral insulin for a period of 29 to 32 months. Together with the results of the Pre-POINT-Early Study, this phase IIb study aims to investigate and consolidate the findings from the pilot Pre-POINT Study, namely safety and immune efficacy at a daily dose of 67.5 mg oral insulin. Since babies and young children will be tested in the GPPAD-POInT-Study, the 67.5 mg dose will be reached by dose escalation starting at 7.5 mg for 2 months, followed by exposure to 22.5 mg for 2 months, and reaching the desired 67.5 mg dose. The GPPAD-POInT-Study aims to recruit 1040 children into the trial. The active substance for oral application is human insulin. Oral Insulin will be applied as a capsule containing 7.5, 22.5 and 67.5 mg of the active substance together with filling substance microcrystalline cellulose.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Type 1 diabetes

Keyword(*) : T1D

Keyword(*) : diabetes mellitus

Keyword(*) : oral insulin

Keyword(*) : oral tolerance

Keyword(*) : autoantigen

Keyword(*) : self tolerance

Keyword(*) : prevention

Keyword(*) : at risk for developing type 1 diabetes

Keyword(*) : juvenile diabetes

Keyword(*) : autoimmune diabetes

Keyword(*) : Diabetes Mellitus, Type 1

Keyword(*) : Diabetes Mellitus

Keyword(*) : Glucose Metabolism Disorders

Keyword(*) : Metabolic Diseases

Keyword(*) : Nutritional and Metabolic Diseases

Keyword(*) : Endocrine System Diseases

Keyword(*) : Autoimmune Diseases

Keyword(*) : Immune System Diseases

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Sponsor (primary)
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Technical University of Munich
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
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Scheme(*) : Not specified
Email address : Not specified
Phone number : Not specified
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Address : Not specified
Web page : Not specified
Digital identifier(s)
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Scheme(*) : Not specified

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Other
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Helmholtz Zentrum München
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Other
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : University Hospital Carl Gustav Carus
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Other
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Kinderkrankenhaus auf der Bult
Details about the contributing person(s)
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Other
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Skane University Hospital
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Other
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Universitaire Ziekenhuizen KU Leuven
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Other
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Medical University of Warsaw
Details about the contributing person(s)
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Other
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : University of Oxford, Clinical Vaccine Research and Immunisation Education
Details about the contributing person(s)
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Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Creator/Author
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Technical University of Munich
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
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Scheme(*) : Not specified
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Alternative identifiers

Type of the registry(*) : NCT (ClinicalTrials.gov)
Identifier(*) : NCT03364868

Type of the registry(*) : Other
Identifier(*) : GPPAD-03-POInT

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Parallel
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Diabetes Mellitus, Type 1
Terminology/classification(*) : Free text
Code of the health condition or disease : Not specified
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Unknown
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Not specified
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : Not specified
Start date : 7 February 2018
End date : 28 June 2024
Mono- or multicentric? : Multicentric
Number of centers : 7
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : Male, Female, Diverse
Inclusion criteria : 1\. Infant between the ages of 4 months and 7 months at the time of randomization.2\. A high genetic risk (\>10%) to develop beta-cell autoantibodies by age 6 years:1. For infants without a first degree family history of type 1 diabetes, high genetic risk is defined as a DR3/DR4-DQ8 or DR4-DQ8/DR4-DQ8 genotype, and a genetic risk score that is \>14.4.2. For infants with a first degree family history of type 1 diabetes, high genetic risk is defined as having HLA DR4 and DQ8, and none of the following protective alleles: DRB1\*1501, DQB1\*0503.3. Solid foods introduced into diet of infant4. Written informed consent signed by the custodial parent(s).
Exclusion criteria : 1. Concomitant disease or treatment that may interfere with the assessments, as judged by the investigators.2. Any condition that could be associated with poor compliance.3. Any medical condition or medical condition coexisting, which, in the opinion of the investigator, may jeopardize the participant's safe participation in the study.4. Diagnosis of diabetes at the time of recruitment.5. Participation in another clinical trial.
Population of the Project(*)
Coverage : Not specified
Country(ies) : Germany
Region(s) and/or city(ies) : - University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven, Leuven, Belgium, Leuven, 3000, Belgium- Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Munich, Germany, Munich, 80804, Bavaria, Germany- AUF DER BULT, Kinder- und Jugendkrankenhaus, Hanover, Germany, Hanover, 30173, Lower Saxony, Germany- Klinik und Poliklinik f. Kinder und Jugendmedizin, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, CRTD/DFG-Forschungszentrum für Regenerative Therapien, Dresden, Germany, Dresden, 01307, Saxony, Germany- Medical University of Warsaw, Department of Paediatrics, Warsaw, Poland, Warsaw, 00-001, Poland- Lund University Dep. of Clinical Sciences Malmo, Skane University Hospital SUS, University Hospital MAS, Malmo, Sweden, Malmö, 202 13, Sweden- Department of Paediatrics Clinical Vaccine Research and Immunisation Education, Children's Hospital, Headington, Oxford, UK, Oxford, OX3 9DU, United Kingdom
Interventions of the Project
Name of the intervention(*) : Oral Insulin
Type of the intervention : Drug (including placebo)
Additional information about the intervention : treatment starting at 4 months - 7 months until age 3.0 years; dose escalation scheme: daily treatment with 7.5 mg or placebo for 2 months; increasing to daily treatment with 22.5 mg or placebo for the following 2 months; increasing to daily treatment with 67.5 mg or placebo until the end of the treatment period.
Name(s) of the arm(s) associated with the given intervention : oral insulin capsule (dose escalation using 3 dose strengths)
Name of the intervention(*) : Placebo
Type of the intervention : Other
Additional information about the intervention : treatment starting at age 4 months - 7 months until age 3.0 years; daily treatment with insulin or placebo capsules containing filling substance (microcrystalline cellulose).
Name(s) of the arm(s) associated with the given intervention : Placebo capsule
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : The development of persistent confirmed multiple beta-cell autoantibodies
Description of the outcome measure : development of persistent confirmed multiple beta-cell autoantibodies (defined as confirmed IAA, confirmed GADA, confirmed IA-2A, or confirmed ZnT8A in two consecutive samples, AND a confirmed second antibody from these four antibodies in one sample.
Type of the outcome measure : Primary
Time point(s) of assessment : elapsed time from treatment assignment (baseline) to first positive sample visit (>2 beta-cell antibodies) in children who develop persistent confirmed multiple beta-cell antibodies. Primary outcome can develop any time up to last study visit at 7.5 yrs
Name of the outcome measure(*) : The development of diabetes
Description of the outcome measure : OGTT criteria or clinical criteria for diabetes as defined by the American Diabetes Association (ADA).
Type of the outcome measure : Primary
Time point(s) of assessment : elapsed time from random treatment assignment (baseline) to the development diabetes (date of diagnosis). This primary outcome measure can develop any time during treatment or follow-up period up to the last study visit at 7.5 years of age
Name of the outcome measure(*) : Any persistent confirmed beta-cell autoantibody or diabetes
Description of the outcome measure : At least one confirmed autoantibody, in two consecutive samples, including GADA, IA-2A, IAA, ZnT8A, or TS7A, or diabetes as defined by the American Diabetes Association (ADA).
Type of the outcome measure : Secondary
Time point(s) of assessment : elapsed time from treatm. assignm. (baseline) to 1st pos. sample for >1 beta-cell antibody in children who developed persist. confirm. beta-cell antibodies OR diabetes onset, whichever is first. outcome can develop any time up to last visit at 7.5 yr
Name of the outcome measure(*) : Persistent confirmed IAA.
Description of the outcome measure : Confirmed IAA in two consecutive samples.
Type of the outcome measure : Secondary
Time point(s) of assessment : elapsed time from treatment assignment (baseline) to first sample that is positive for IAA in children who develop persistent confirmed IAA. Outcome can develop any time during treatment or follow-up period up to the last study visit at 7.5 years of age.
Name of the outcome measure(*) : Persistent confirmed GADA.
Description of the outcome measure : Confirmed GADA in two consecutive samples.
Type of the outcome measure : Secondary
Time point(s) of assessment : elapsed time from treatment assignment (baseline) to the first sample that is positive for GADA in children who develop persistent confirmed GADA. Outcome can develop any time up to the last study visit at 7.5 years of age
Name of the outcome measure(*) : Abnormal glucose tolerance (AGT) defined by dysglycemia or diabetes.
Description of the outcome measure : Dysglycemia is defined as impaired fasting plasma glucose of ≥110 mg/dL (6.1 mmol/L), or impaired 2-hour glucose of ≥140 mg/dL (7.8 mmol/L), or high glucose levels at intermediate time points on OGTT (30, 60, 90 min) levels of ≥200mg/dL (11.1 mmol/L)). Diabetes is defined according to the criteria of the American Diabetes Association (ADA).
Type of the outcome measure : Secondary
Time point(s) of assessment : elapsed time from treatment assignment to the date at which abnormal glucose tolerance or diabetes is diagnosed. Outcome can develop any time up to the last study visit at 7.5 years of age
Additional information about the Project : Are healthy volunteers permitted to participate in the clinical study?: TrueIs eligibility based on gender (not on sex)?: Additional information about gender eligibility criteria:
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Undecided, it is not yet known if data will be made available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Phase-2
Masking of intervention(s) assignment
Masking implemented? : true
Who is masked? : Participant, Care provider, Investigator, Outcomes assessor
Additional information about masking : Not specified
Type of allocation of participants to an arm : Randomized
Off-label use of a drug product : Not specified

Primary Oral Insulin Trial

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