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    Summary
    EudraCT Number:2009-017329-20
    Sponsor's Protocol Code Number:INIT/002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-05-05
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2009-017329-20
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled trial of intranasal insulin (440IU) in children and young adults at risk of type 1 diabetes: INTRANASAL INSULIN TRIAL II
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Type 1 Diabetes Prevention Trial: Intranasal Insulin Trial II
    A.3.2Name or abbreviated title of the trial where available
    INIT II
    A.4.1Sponsor's protocol code numberINIT/002
    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 SponsorMelbourne Health, Royal Melbourne Hospital
    B.1.3.4CountryAustralia
    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 supportMelbourne Health
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMelbourne Health, Royal Melbourne Hospital
    B.5.2Functional name of contact pointINIT II Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressGrattan Street
    B.5.3.2Town/ cityParkville
    B.5.3.3Post codeVictoria 3050
    B.5.3.4CountryAustralia
    B.5.6E-mailjerry.kanellos@mh.org.au
    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.3.2Product code DV001 (Human recombinant Insulin formulation)
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNintranasal insulin
    D.3.9.2Current sponsor codeDV001
    D.3.9.3Other descriptive nameintranasal human insulin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 placeboNasal spray
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type-1-Diabetes
    E.1.1.1Medical condition in easily understood language
    Risk of Type 1 Diabetes
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to determine whether intranasal administration of insulin to young children and adults at risk for type 1 diabetes (T1D) will reduce their rate of development of diabetes.
    E.2.2Secondary objectives of the trial
    Secondary objective is to determine whether intranasal insulin administration to children and young adults at risk for T1D will:
    1) prevent expected loss of pancreatic ß-cell function
    2) improve insulin action
    3) stimulate immune responses consistent with the induction of immune tolerance to insulin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. First-degree or 2nd-degree relative of person with T1D diagnosed before age 40;
    2. Age 4-30 years if 1st-degree relative
    Age 4-20 years if 2nd-degree-relative
    3. Confirmed serum antibodies to 2 or more islet antigens
    4. Normal OGTT
    5. FPIR at or above threshold - Primary Stratum: ≥ 10th
    percentile for siblings, offspring and second-degree
    relatives of someone with T1D (≥ 100uU/ml if aged ≥ 8
    years or ≥ 60uU/ml if aged < 8 years) and ≥ 1st percentile
    for parents of someone with T1D (≥ 60uU/ml); Secondary
    Stratum: ≥ 1st <10th percentile for siblings, offspring and
    second-degree relatives of someone with T1D (≥ 50uU/ml
    <100uU/ml if aged ≥ 8 years or ≥ 20uU/ml < 60uU/ml if
    aged < 8 years)
    6. Provision of written consent
    E.4Principal exclusion criteria
    1. History of treatment with insulin or oral hypoglycaemic
    agents
    2. Known diabetes by ADA/WHO criteria (fasting plasma
    glucose ³7mM or 2 hour plasma glucose in the OGTT ³
    11.1mM).
    3. Pregnant or lactating, or of child-bearing potential not using a highly effective method of contraception (failure rate <1% per year when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner).
    4. Concomitant disease or treatment which may interfere
    with assessment or cause immunosuppression, as judged
    by the investigators.
    5. Uncorrected vitamin D deficiency (serum 25OHD <50nM).
    6. Known alcohol or drug abuse, psychiatric or other condition that could be associated with poor compliance.
    7. Known liver disease, or persisting elevation of plasma
    AST (³ 100 IU/L) or ALT (³ 110 IU/L) levels.
    8. Impaired renal function (serum creatinine ³ 110uM in
    females or ³ 130uM in males).
    9. Any defect or pathology of nasal passage which would
    preclude application of the intranasal spray.
    E.5 End points
    E.5.1Primary end point(s)
    The onset of diabetes, defined by ADA/WHO criteria
    E.5.1.1Timepoint(s) of evaluation of this end point
    6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108 and 120 months
    E.5.2Secondary end point(s)
    B-cell function assessed by the glucose and insulin responses in the OGTT
    Insulin resistance assessed by HOMA-R
    Iselt autoantibody levels and T cell responses to islet autoantigens
    E.5.2.1Timepoint(s) of evaluation of this end point
    6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108 and 120 months
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Germany
    New Zealand
    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
    intervention of 12 months and follow-up monitoring for at least 4 years and maximum 10 years.
    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.1.1Number of subjects for this age range: 95
    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.1.1.5.1Number of subjects for this age range: 48
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 47
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 7
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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
    includes children from 4 years onwards with familial risk to develop diabetes type 1 and risk due to positivity for diabetes-associated autoantibodies (see also protocol page 24, chapter 5.4).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 102
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participants are followed-up for a minimum of four years after intervention is completed. After completion of the whole trial participants are invited by the site to follow-up islet-autoanitibody measurements and monitoring of diabetes risk or diabetes development.
    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 Decision2010-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-05-31
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