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    EudraCT Number:2016-002127-28
    Sponsor's Protocol Code Number:16016762
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-31
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2016-002127-28
    A.3Full title of the trial
    The impact of subcutaneous glucagon
    before, during and after exercise. A study in patients with type 1 diabetes mellitus
    Virkningen af glukagon før, under og efter træning
    Hos personer med type 1 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The impact of a glucagon injection before, during and after exercise. A study in patients with type 1 diabetes mellitus
    Virkningen af glukagon før, under og efter træning
    Hos personer med type 1 diabetes
    A.3.2Name or abbreviated title of the trial where available
    The impact of a glucagon injection before, during and after exercise
    A.4.1Sponsor's protocol code number16016762
    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 SponsorHvidovre University Hospital
    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 supportDanish Diabetes Association
    B.4.1Name of organisation providing supportZealand Pharma
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHvidovre University Hospital
    B.5.2Functional name of contact pointIsabelle
    B.5.3 Address:
    B.5.3.1Street AddressKettegård Allé, 30
    B.5.3.2Town/ cityHvidovre
    B.5.3.3Post code2650
    B.5.4Telephone number+4551519085
    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 Yes
    D. name GlucaGen
    D. of the Marketing Authorisation holderNovo Nordisk
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameGlucaGen
    D.3.2Product code SUB02347MIG
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    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 placeboConcentrate and solvent for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with type 1 diabetes mellitus
    Personer med type 1 diabetes mellitus
    E.1.1.1Medical condition in easily understood language
    Metabolic disease in which a person has high blood glucose values due to insufficient insulin production
    Metabolisk sjukdom med för höga blodsocker på grund av avsaknad av insulin produktion.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10012608
    E.1.2Term Diabetes mellitus insulin-dependent
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To compare the increase in plasma glucose after 200µg glucagon given either after exercise or after resting for 45 minutes.
    E.2.2Secondary objectives of the trial
    2. To determine whether a subcutaneous glucagon injection just before exercise has a greater impact on hepatic glucose production and thereby is superior to an injection after exercise in preventing hypoglycemia during and two hours after exercise.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18 - 70 years
    - T1D ≥ 2 year
    - BMI 20-30 kg/m2
    - Insulin pump ≥ 1 year.
    - HbA1c < 69 mmol/mol (8.5 %)
    - Hypoglycemia awareness (reported by Gold et al.)
    - Use of carbohydrate counting and the insulin pump bolus calculator for all meals
    E.4Principal exclusion criteria
    Allergy or intolerance to lactose or GlucaGen® (Novo Nordisk, Bagsværd, DK)
    - Impaired renal function (eGFR < 60 ml/min/1.73m2)
    - Liver disease with ALAT > 2.5 times the upper limit of the reference interval
    - Use of anti-diabetic medicine (other than insulin), per oral corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
    - Known or suspected alcohol or drug abuse
    - Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
    - Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
    - Inability to understand the patient information and to give informed consent
    - Physical or mental incapacity to perform exercise
    -People with vigorous intensity aerobic physical activity such as swimming, jogging, aerobics, football, tennis, gym, workout etc, more than 3 hours or more per week.
    - Chronic use or unable to stop acetaminophen (paracetamol) use
    -Allergy to the patch of CGM sensors
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is peak plasma glucose achieved within 2 hours after the 200 μg subcutaneous glucagon injection. In the primary analysis, we will compare the peak plasma glucose after exercise and after resting.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 hours after injection of glucagon as mentioned in E.5.1
    E.5.2Secondary end point(s)
    1) The time-to-peak value after glucagon injection.
    2) Duration of the glucagon effect; equal to the time point from glucagon injection to when plasma glucose is below baseline.
    3) The glycaemic effect, calculated as the total area under the curve (tAUC) after each glucagon injection.
    4) Changes after each glucagon injection (ketone bodies, lactic acid glucagon, and FFA/TG).
    5) Differences of continuously glucose monitoring placed at different sites on the patient during exercise compared to plasma glucose monitoring.
    6) Number of events of hypoglycemia (plasma glucose ≤3.9 mmol/l) in the three study groups.
    7) Number of re-events of hypoglycemia (plasma glucose ≤3.9 mmol/l) 30 minutes after first event in the three study groups.
    8) Number of rebound hyperglycemia (plasma glucose ≥10.0 mmol/l).
    9) To test the difference in mean absolute relative difference (MARD) during the study visits between the two sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference value.
    10) To test the difference in MARD between the two CGM sites (CGMarm vs. CGMabdomen) during the four days after the study day using the daily 8 prespecified plasma glucose measurements by Bayer Contour Link as the reference value.
    11) To test the difference in MARD during the hypoglycemia range (≤3.9 mmol/l) of the study visits between the two sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference value.
    12) To test the difference in MARD during the euglycemia range (>3.9 mmol/l and < 10.0 mmol/l) of the study visits between the two sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference.
    13) To test the difference in MARD during the hyperglycemia range (≥10.0 mmol/l) of the study visits between the two Dexcom G4 sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference value.
    14) To test the difference in MARD between the two sensor sites (CGMarm vs. CGMabdomen) from day 1- 7 with the Bayer Contour Link as the reference value.
    15) To compare the rate-of change (ROC) accuracy of the two sensors with the actual rate-of-change (ROC) of PG measured by the YSI 2300 STAT PLUS.
    16) To determine the Precision Absolute Relative Difference PARD (=CGM readings of one system will be subtracted from CGM readings of the other system, and this difference will be divided by the average of the CGM readings of the abdominal sensors, i.e. CGMabdomen is used as reference):
    a. from day 1- 7 with
    b. during the study visits
    17) To test the difference of the sensors’ sensitivity and specificity to detect a hypoglycemic event. A hypoglycemic period is defined as three consecutive blood glucose values ≤3.9 mmol/l measured with 5 minutes interval on a YSI or one measurements ≤ 3.9 mmol/l by self-monitoring of blood glucose by finger stick measurements.
    18) To evaluate the point accuracy of both sensors with the Clarke error grid analysis
    19) To evaluate the pressure induced sensor attenuation (PISA) by using a recent fault detection algorithm that can detect non-physiologic anomalous low sensor readings.
    20) To fuse the data from the two sensors in order to have one combined processed CGM signal which is more accurate and has less uncertainty than the readings from the individual sensors. We will use novel data fusion techniques to achieve this goal
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation is performed during the study days and 4 days after.
    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 Yes
    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. 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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months2
    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 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: 14
    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.4.1In the member state14
    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)
    The subjects will go back to their normal treatment for type 1 diabetes mellitus.
    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 Decision2016-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-07
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