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    Summary
    EudraCT Number:2018-003834-34
    Sponsor's Protocol Code Number:ZP4207-17084
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-01-07
    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 ConcernedAustria - BASG
    A.2EudraCT number2018-003834-34
    A.3Full title of the trial
    A phase 3b, randomized, double-blind, crossover trial to compare the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with type 1 diabetes mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 3b, randomized, double-blind, crossover trial to compare the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with type 1 diabetes mellitus
    A.3.2Name or abbreviated title of the trial where available
    XTime
    A.4.1Sponsor's protocol code numberZP4207-17084
    A.5.4Other Identifiers
    Name:IND #Number:127866
    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 SponsorZealand Pharma A/S
    B.1.3.4CountryDenmark
    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 supportZealand Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZealand Pharma A/S
    B.5.2Functional name of contact pointStine Just Maarbjerg
    B.5.3 Address:
    B.5.3.1Street AddressSmedeland 36
    B.5.3.2Town/ cityGlostrup
    B.5.3.3Post code2600
    B.5.3.4CountryDenmark
    B.5.4Telephone number+45 8877 3600
    B.5.5Fax number+45 8877 3895
    B.5.6E-mailsjm@zealandpharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 nameDasiglucagon A
    D.3.2Product code ZP4207
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDasiglucagon
    D.3.9.1CAS number 1544300-84-6
    D.3.9.2Current sponsor codeZP4207
    D.3.9.3Other descriptive nameDasiglucagon (batch A)
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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 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 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.IMP: 2
    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 nameDasiglucagon B
    D.3.2Product code ZP4207
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDasiglucagon
    D.3.9.1CAS number 1544300-84-6
    D.3.9.2Current sponsor codeZP4207
    D.3.9.3Other descriptive nameXTime
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 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 mellitus
    E.1.1.1Medical condition in easily understood language
    Type 1 Diabetes mellitus
    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 20.0
    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
    The primary objective is to show non-inferiority of the efficacy of a single subcutaneous dose of dasiglucagon batch B relative to that of dasiglucagon batch A for treatment of hypoglycemia in patients with type 1 diabetes mellitus
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the safety, immunogenicity and PK of 2 different batches of dasiglucagon following a single SC dose administered to patients with T1DM with insulin-induced hypoglycemia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be eligible to be included in the trial only if all of the following criteria apply:
    1. Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the patient)
    2. Female or male patients with T1DM for at least 1 year, diagnostic criteria as defined by the American Diabetes Association (American Diabetes Association, 2017)
    3. Treated with insulin for T1DM for at least 1 year and with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening
    4. Hemoglobin A1c <10.0% at screening
    5. Age between 18 and 75 years, both inclusive, at screening
    6. A female subject must meet one of the following criteria:
    a) Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the trial from screening and until last follow-up visit. An acceptable method of contraception includes one of the following:
    i. Abstinence from heterosexual intercourse (only acceptable if corresponding to the preferred and usual lifestyle of the subject)
    ii. Systemic contraceptives (birth control pills, injectable/implant/ insertable hormonal birth control products, transdermal patch)
    iii. Intrauterine device (with and without hormones)
    iv. Condom with spermicide

    [Germany only: An acceptable method of contraception includes one of the following:
    I. Total heterosexual sexual abstinence can be used as a method of contraception if this is the participant's preferred lifestyle and the method is established. Periodic sexual abstinence is not an acceptable method of contraception
    II. Single method (use only one method):
    • Intrauterine device (IUD)
    • Hormone rod inserted under the skin
    • Male partner's sterilization
    III. Double method:
    • Hormone contraception A) estrogen and/or progesterone oral contraceptives, B) transdermal patch, C) vaginal ring, D) injection
    • In combination with one of the following: a) vaginal cap with spermicide, b) vaginal sponge (only for women who have never given birth), c) condom, d) female condom ]

    b) Participant is of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation), or in a menopausal state (at least 1 year without menses).
    7. A male subject must meet the following criteria: Surgically sterilized or willing to refrain from sexual intercourse from screening and until last follow-up visit or, if sexually active, uses condom and partner practices contraception during the trial from screening and until last follow-up visit.
    E.4Principal exclusion criteria
    Patients are excluded from the trial if any of the following criteria apply:
    1. Previous participation in a clinical trial within the dasiglucagon program
    2. Known or suspected allergy to trial medication(s) or related products
    3. History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema)
    4. Previous participation in this trial. Participation is defined as having been randomized
    5. Females who are pregnant according to a positive pregnancy test, are actively attempting to get pregnant, or are lactating
    6. History of hypoglycemic events associated with seizures or hypoglycemia unawareness in the last year prior to screening
    7. Current daily basal insulin treatment > 1.0 U/kg/day
    8. History of epilepsy or seizure disorder
    9. History of severe hypoglycemia (an episode requiring assistance from another person) in the last month prior to screening
    10. Receipt of any investigational medicinal product within 3 months prior to screening
    11. Active malignancy within the last 5 years
    12. Congestive heart failure, New York Heart Association class II-IV
    13. Inadequately treated blood pressure as defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥90 mmHg at screening (The Task Force for the management of arterial hypertension, 2013)
    14. Current bleeding disorder, including use of anticoagulant treatment
    15. Known presence or history of pheochromocytoma (i.e., adrenal gland tumor) or insulinoma (i.e., insulin-secreting pancreas tumor)
    16. Use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs at screening
    17. Any of the following abnormal laboratory parameters at screening:
     Aspartate aminotransferase >2.5 × the upper limit of normal
     Alanine aminotransferase >2.5 × the upper limit of normal
     Bilirubin >1.5 × the upper limit of normal
     Estimated glomerular filtration rate <30 mL/min/1.73m2 according to the Modification of Diet in Renal Disease Study definition (Levey et al, 2006)
     Altered electrolyte values of clinical relevance for cardiac conduction, as judged by the investigator
    18. Clinically significant abnormal electrocardiogram (ECG) at screening as evaluated by investigator
    19. Clinically significant illness within 4 weeks before screening, as judged by the investigator
    20. Any donation of blood or plasma in the past month, or donation in excess of 500 mL within 12 weeks before screening
    21. Surgery or trauma with significant blood loss within the last 2 months before screening
    22. A positive result in the alcohol and/or urine drug screen at the screening visit
    23. Significant history of alcoholism or non-prescribed opioid misuse as judged by the investigator
    24. Patients with mental incapacity or language barriers that preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of the investigator should not participate in the trial
    25. Any condition interfering with trial participation or evaluation or that could be hazardous to the patient
    26. The use of prescription or non-prescription medications known to cause QT prolongation.
    E.5 End points
    E.5.1Primary end point(s)
    Time to plasma glucose recovery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Plasma glucose recovery is defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline during the hypoglycemic clamp procedure without administration of rescue intravenous (IV) glucose.
    E.5.2Secondary end point(s)
    Plasma glucose change from baseline at 30 minutes, at 20 minutes, at 15 minutes, and at 10 minutes after trial product injection or at the time of rescue
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline at 30 minutes, at 20 minutes, at 15 minutes, and at 10 minutes after trial product injection or at the time of rescue.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA3
    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
    Austria
    Canada
    Germany
    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.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 77
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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.4.1In the member state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 88
    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)
    Not applicable for this trial.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-29
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