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    Summary
    EudraCT Number:2006-006550-96
    Sponsor's Protocol Code Number:808040005
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2006-006550-96
    A.3Full title of the trial
    Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Oral Insulin for Prevention of Diabetes in People with Family Members with Type 1 Diabetes
    A.4.1Sponsor's protocol code number808040005
    A.5.4Other Identifiers
    Name:INDNumber:76,419
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTrialNet Study Group
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportDepartment of Health and Human Services
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportAmerican Diabetes Association
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportNational Institutes of Health (NIH)
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportJuvenile Diabetes Research Foundation (JDRF)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrialNet Coordinating Center (TNCC)
    B.5.2Functional name of contact pointKelly Sadler
    B.5.3 Address:
    B.5.3.1Street AddressPediatrics Epidemiology Center at the University of South Florida, 3650 Spectrum Blvd, Suite 100
    B.5.3.2Town/ cityTampa, Florida
    B.5.3.3Post code33612
    B.5.3.4CountryUnited States
    B.5.6E-mailtrialnetinfo@epi.usf.edu
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namehuman insulin
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 11061-68-0
    D.3.9.3Other descriptive namerecombinant human insulin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typerecombinant human hormone
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Oral insulin is to be used for the prevention of type 1 diabetes mellitus in relatives at risk of developing the disease.
    E.1.1.1Medical condition in easily understood language
    Type 1 Diabetes
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10066284
    E.1.2Term Diabetes prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine whether intervention with repeated oral administration of recombinant human insulin, the potential autoantigen, will prevent or delay the development of clinical Type 1 Diabetes Mellitus (T1DM) in non-diabetic relatives of patients with T1DM who are positive for insulin autoantibodies but who do not have a metabolic defect.
    E.2.2Secondary objectives of the trial
    Secondary objectives include the description of the effects of treatment with oral insulin versus placebo in other catagories of subjects defined using different combinations of autoantibodies and metabolic status and an assessment of the consistency of treatment effect among strata. Secondary objectives also include the assessment of the effects of treatment on immunologic and metabolic markers, and the association of these markers with the risk of diabetes onset, among other possible risk factors.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have a proband* with T1DM.

    2. If the proband is a sibling, parent or a child, the study participant must be 3 - 45 years of age. If the proband is a second or third degree relative (i.e. Niece, Nephew, Aunt, Uncle, Grandparent, Cousin), the study participant must be 3-20 years of age.

    3. Willing to sign Informed Consent Form.

    4. Has normal glucose tolerance on an OGTT performed within 7 weeks prior to randomization. If previous abnormal glucose tolerance, has had two consecutive OGTT with normal glucose tolerance.

    5. mIAA confirmed positive within the previous six months.

    6. At least one other antibody present on two separate samples, one of which was drawn within the past six months.

    * A proband is an individual diagnosed with diabetes before age 40 and started on insulin therapy within 1-year of diagnosis. Probands considered to have type 1 diabetes by their physician who do not meet this definition will be referred to the TrialNet Eligibility Committee.
    E.4Principal exclusion criteria
    1. Does not satisfy the above inclusion criteria.

    2. Has severe active disease, e.g. chronic active hepatitis, severe cardiac, pulmonary, renal, hepatic, immune deficiency and/or disease that is likely to limit life expectancy or lead to therapies such as immunosuppression during the time of the study.

    3. Prior participation in a clinical trial for secondary prevention of T1DM.

    4. History of treatment with insulin or oral hypoglycemic agent.

    5. History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids within the past two years for a period of more than three months.

    6. Ongoing use of medications known to influence glucose tolerance, i.e. sulfonylureas, growth hormone, metformin, anticonvulsants, thiazide or potassium depleting diuretics, beta adrenergic blockers, niacin. Subjects on such medications should be changed to a suitable alternative, if available, and will become eligible one month after medication is discontinued.

    7. Pregnant or intends to become pregnant while on study or lactating.

    8. Deemed unlikely or unable to comply with the protocol.

    9. OGTT that reveals abnormal glucose tolerance unless two subsequent consecutive OGTT have normal glucose tolerance. Abnormal glucose tolerance is defined as:
    •fasting plasma glucose ≥ 110 mg/dL (6.1 mmol/l), AND/OR
    •2 hour plasma glucose ≥ 140 mg/dL (7.8 mmol/l) AND/OR
    •30, 60, or 90 minute plasma glucose ≥ 200 mg/dL (11.1 mmol/l)

    10 . Subject has HLA DQA1*0102, DQB1*0602 haplotype.
    E.5 End points
    E.5.1Primary end point(s)
    The elapsed time from treatment randomisation to the development of diabetes among those enrolled in the primary analysis cohort consisting of subjects with insulin autoimmunity and absence of metabolic abnormalities. Criteria for Diabetes onset are defined by the American Diabetes Association (ADA) based on glucose testing, or the presence of symptoms and unequivocal hyperglyglycemia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 years
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Italy
    New Zealand
    Sweden
    Australia
    Finland
    Germany
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study will end when the accrued numbers of subjects developing diabetes provide I = 27.551. I = (DO DC)/DT where DO and DC refer to
    the number of subjects who have developed diabetes in the oral insulin
    and control groups, respectively, and DT refers to the total number of
    such subjects.
    The information required to provide 85% power to detect a 40% risk
    reduction with a one-sided logrank test at the 0.05 significance level is
    I = 27.551.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors 3-17 years old - their parents will give consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 300
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-01
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