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    Summary
    EudraCT Number:2015-003732-12
    Sponsor's Protocol Code Number:AMG109
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-09-18
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-003732-12
    A.3Full title of the trial
    A multiple center, open label, prospective, observational study to evaluate the effectiveness and ease-of-use of AMG504-1 administered in the home or school environments for treating hypoglycemia in children and adolescents with type 1 diabetes (T1D)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to examine ease-of-use of AMG504-1 administered in the home or school environments for treating hypoglycemia in children and adolescents with diabetes
    A.4.1Sponsor's protocol code numberAMG109
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02402933
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/184/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLocemia Solutions ULC
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLocemia Solutions ULC
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLocemia Solutions ULC
    B.5.2Functional name of contact pointDirector of Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address8505 Dalton,
    B.5.3.2Town/ city Montréal
    B.5.3.3Post codeH4T 1V5
    B.5.3.4CountryCanada
    B.5.6E-mailpatricia.stotland@locemia.com
    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 nameglucagon
    D.3.2Product code AMG504-1
    D.3.4Pharmaceutical form Nasal powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNglucagon
    D.3.9.1CAS number 9007-92-5
    D.3.9.2Current sponsor codeAMG504-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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 Yes
    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 No
    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 No
    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
    E.1.1.1Medical condition in easily understood language
    Diabetes
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effectiveness of intranasal (IN) glucagon administered under clinical use in treating episodes of severe or moderate hypoglycemia in children and adolescents with Type 1 diabetes.
    E.2.2Secondary objectives of the trial
    To assess ease-of-use of intranasally administered glucagon in the hands of caregivers of children and adolescents who may be called upon to treat episodes of severe or moderate hypoglycemia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Child/Adolescent with diabetes (C/AWD) and their caregiver(s) meeting all of the following criteria will be considered for enrollment in the study:
    1. Availability for the entire study period.
    2. Motivated C/AWD and caregiver(s) and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the qualified investigator or designee.
    3. C/AWD lives with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia.
    4. Male or female C/AWD with a history of type 1 diabetes >1 year.
    5. C/AWD aged of at least 4 years of age but less than 18 years.
    6. A female C/AWD must meet one of the following criteria:
    a) Participant is of child-bearing potential and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the study (from the pre-trial evaluation and enrollment visit until study completion). An acceptable method of contraception includes one of the following:
    • Abstinence from heterosexual intercourse
    • Systemic contraceptives (birth control pills, injectable/implantable/ insertable hormonal birth control products, transdermal patch)
    • Intrauterine device
    • Condom with spermicide
    or
    b) Participant is of non-child-bearing potential, defined as a female who had a hysterectomy or tubal ligation, is clinically considered infertile or has not yet reached menarche.
    7. In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the Investigator is a suitable candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations.
    8. Willingness to adhere to the protocol requirements.
    The informed consent form must be signed by all C/AWD (as applicable) and primary caregiver(s), prior to their participation in the study.
    E.4Principal exclusion criteria
    C/AWD presenting any of the following will not be included in the study:
    1. Females who are pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or lactating.
    2. History of significant hypersensitivity to glucagon, or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs.
    3. Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the investigator could interfere with the absorption, distribution, metabolism or excretion of drugs or could potentiate or predispose to undesired effects.
    4. Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
    5. Use of daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.
    6. Concomitant maintenance therapy with any drug that would influence the outcome of the trial, at the discretion of the Investigator and the Sponsor.
    7. Regular consumption of 3 or more units of alcoholic beverages per day.
    8. Current participation in another clinical trial, intent to enroll in another clinical trial during this clinical study or use of an Investigational Product (in another clinical trial) within the prior 30 days.
    Participants will be allowed to receive investigational treatment in this study more than once.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (defined as return to normal state or awaking) recovering conscious or stop convulsing
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 minutes.
    E.5.2Secondary end point(s)
    User-friendliness – caregive to complete questionnaire as soon as possible after dosing, and will discuss with investigator within 24 hours post-dose. Caregiver to report to investigator within 24 hours to discuss, and complete questionnaire.

    Recovery – if unconscious, time to recovery reported. If not unconscious, time to recover to normal state reported

    Adverse events – events occurring up to 5-hours post-dose reported

    Blood glucose measurements (PD) 15, 30, 45 minutes post-dose (if possible)

    Tolerability – nasal questionnaire – within 2 hours of recovery (if possible)

    Follow-up - 2,4 month visits, end-of-study visit (6 months) Resolution of adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood glucose 15, 30, 45 minutes after dosing.
    Tolerability within 2 hours
    Adverse events within 5 hours
    Questionnaire at 24 hours and follow up at 2, 4 and 6 months
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    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: 30
    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: 8
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 4
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    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)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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