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    Summary
    EudraCT Number:2005-004526-72
    Sponsor's Protocol Code Number:1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-02-06
    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 number2005-004526-72
    A.3Full title of the trial
    A randomised controlled study of continuous subcutaneous insulin infusion (CSII) therapy compared to conventional bolus insulin treatment in preschool aged children with Type 1 diabetes.
    A.3.2Name or abbreviated title of the trial where available
    n/a
    A.4.1Sponsor's protocol code number1
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number77773974
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAddenbrooke's NHS Trust
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Medtronic MiniMed 508, 511 & 512/712 insulin infusion pump
    D.2.1.1.2Name of the Marketing Authorisation holderMedtronic Ltd, MiniMed Division
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameInsulin infusion pump
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) No
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 typeInsulin infusion pump device
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 Diabetes Mellitus
    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
    AIMS OF THE STUDY.
    The principal aims of this study are to establish whether treatment with continuous subcutaneous insulin infusion (CSII) therapy has advantages over conventional bolus subcutaneous insulin injection treatment regimens in terms of
    1. achieving better glycaemic control
    2. reducing hypoglycaemia risk
    3. preserving endogenous insulin secretion
    4. providing a better quality of life for parents and families.

    PRIMARY OBJECTIVES.
    The objectives will be to determine whether compared to conventional treatment CSII therapy results in :
    1. Improved glycaemic control - as determined by HbA1c index values
    2. Reduced frequency of hypoglycaemia - both daytime and nocturnal
    3. Better psychological outcome and adjustment to diagnosis and treatment - as determined in the parents and siblings of patients
    E.2.2Secondary objectives of the trial
    SECONDARY OBJECTIVES.
    1. To determine whether CSII therapy results in longer preservation of endogenous insulin secretion compared to conventional insulin treatment - as evidenced by fasting plasma C-peptide production and lower daily insulin requirements (units/kg/day) assessed at 6 monthly intervals until 2 years after onset of treatment.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Inclusion Criteria
    i. Newly diagnosed Type 1 diabetes mellitus
    ii. Age at diagnosis < 3.99 years
    E.4Principal exclusion criteria
    i. Neurological disability / handicap e.g. Cerebral palsy
    ii. Gastrointestinal disease
    iii. Chronic illness other than T1DM that may affect conduct of study
    E.5 End points
    E.5.1Primary end point(s)
    OUTCOME MEASURES
    i. Glycaemic control.
    The glycated haemoglobin index (HbA1c) will be measured at each local diabetes clinic at 8 to 12 week intervals from diagnosis as per routine clinical care.

    A central (Addenbrooke's hospital) measurement of HbA1c will be performed on all children at 0, 3, 6, 12, 18 and 24 months.

    ii. Hypoglycaemia frequency.
    a). Home blood glucose monitoring data.
    Families will be supplied with a standard home blood glucose monitoring device with a data storage / memory facility.

    Parents will be encouraged to perform regular daily blood glucose tests which should be performed at conventional times - e.g. before meals and bed. Test results will also be recorded in standard blood sugar monitoring book.

    All participating families will be encouraged to perform a minimum of 4 blood tests per day on their children.

    All hypoglycaemic episodes or suspected episodes should be recorded and verified with a blood glucose test.

    Stored data from the home blood glucose monitoring device will be downloaded onto computer at the local clinic at 8 to 12 week intervals, for later analysis.

    Parent-held home blood glucose monitoring record books will be collected at 12 week intervals.

    b). Continuous Glucose Monitoring System (CGMS).
    24 hour glycaemic profiles will be determined using the MiniMed CGMS device.

    The MiniMed CGMS device will be used to record 3 consecutive days of glucose profiles at 3, 6, 12 and 24 months.

    The paediatric insulin pump nurse will liase with the families and the local clinics in implementing the CGMS protocol (Appendix 2).

    iii. Auxology.
    Weight, and length (height) will be determined at each clinic visit or at least a 3 monthly intervals.

    Ht, wt and body mass index SDS will be calculated using 1990 UK growth standards.

    iv. C-peptide
    Plasma C-peptide will be determined centrally (Cambridge) from blood sample obtained at diagnosis (before start of insulin therapy)..

    Plasma c-peptide will also be measured at 6, 12, 18 and 24 months after initiation of therapy both on an early morning fasting sample).


    v. Quality of life(QoL) assessment
    A questionnaire examining QoL factors will be used to assess the impact of the diabetes treatment regimen in terms of the parents satisfaction and perceptions of their performance, lifestyle and family dynamics. A modified version of the validated Indiana University Diabetes Research & Training Centre – Parents Diabetes Quality of life Questionnaire will used (see attached).
    QoL will be assessed at 3, 6, 12, 18 and 24 months after the initiation of therapy
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    quality of life
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Conventional subcutaneous bolus insulin injection therapy
    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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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
    Consent will be given by the child's parent or legal guardian.
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 20
    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 Decision2006-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2006-11-03
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