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    Summary
    EudraCT Number:2019-001631-31
    Sponsor's Protocol Code Number:DHCL2019
    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:2019-04-26
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-001631-31
    A.3Full title of the trial
    Dual-Hormone Closed-Loop Glucose Control in Type 1 Diabetes
    Automatisk regulering af blodsukkeret med insulin og glukagon hos patienter med type 1 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Automated blood glucose control with insulin and glucagon in patients with type 1 diabetes
    Automatisk regulering af blodsukkeret med insulin og glukagon hos patienter med type 1 diabetes
    A.3.2Name or abbreviated title of the trial where available
    Dual-Hormone Closed-Loop
    A.4.1Sponsor's protocol code numberDHCL2019
    A.5.4Other Identifiers
    Name:Former EUDRA-CTNumber:2014-003261-20
    Name:Former Protocol code numberNumber:DHCL2014
    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 SponsorSteno Diabetes Center Copenhagen
    B.1.3.4CountryDenmark
    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 supportSteno Diabetes Center Copenhagen
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSteno Diabetes Center Copenhagen
    B.5.2Functional name of contact pointAjenthen Ranjan
    B.5.3 Address:
    B.5.3.1Street AddressNiels Steensens vej 2
    B.5.3.2Town/ cityGentofte
    B.5.3.3Post code2820
    B.5.3.4CountryDenmark
    B.5.4Telephone number4523742766
    B.5.5Fax number453823742766
    B.5.6E-mailAjenthen.Ranjan@regionh.dk
    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.2.1.1.1Trade name GlucaGen
    D.2.1.1.2Name 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLUCAGON
    D.3.9.1CAS number 16941-32-5
    D.3.9.4EV Substance CodeSUB02347MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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 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 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 Yes
    D.2.1.1.1Trade name FiAsp(R), insulin aspart
    D.2.1.1.2Name 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 nameFiAsp
    D.3.2Product code SUB08195MIG
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INNINSULIN ASPART
    D.3.9.1CAS number 116094-23-6
    D.3.9.4EV Substance CodeSUB08195MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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
    Patients with type 1 diabetes
    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
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    The aims of this two-phase project are to 1) demonstrate proof-of-concept and 2) to compare dual-hormone with single-hormone closed-loop glucose control.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years
    - T1D ≥ 2 years
    - Insulin pump therapy ≥ 1
    - Currently using FiAsp® - insulin
    - HbA1c ≤ 8.5% (69 mmol/mol)
    E.4Principal exclusion criteria
    - Pregnancy or nursing
    - Inability and willingness to comply with all protocol procedures, e.g. exercise, sleeping, blood sampling, and meal consumption
    - Plan to become pregnant or sexually active and not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)
    - Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when blood glucose is < 3.0 mmol/l)
    - Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation
    - History of coronary artery disease or congestive heart failure
    - Abnormal ECG suggestive of coronary artery disease and increased risk of malignant arrhythmia
    - Allergy to glucagon or lactose
    - Pheochromocytoma
    - Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation

    Withdrawal criteria
    - In case of pregnancy (or desire for pregnancy), female subjects are withdrawn
    - Lack of compliance to any of the important study procedures in the discretion of the investigator
    - Unacceptable adverse effects in the discretion of the investigator
    - Withdrawal on participants request will be accepted at any time without further justification
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of time with glucose values < 3.9 mmol/l as measured by CGM*
    Number of CHO interventions to treat hypoglycemia*
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation is performed after completion of the second study session, i.e. after two times 33-hours
    E.5.2Secondary end point(s)
    Secondary outcomes between single- and dual-hormone closed-loop system:
    - Percentage of time with glucose values < 3.9 mmol/l as measured by YSI*
    - Composite outcome: Percentage of participants achieving (1) time in range (3.9-10) > 70 %, (2) time in alert hypoglycemia (<3.9 mmol/l) < 4 %, and (3) time in clinical hypoglycemia (<3.0 mmol) < 1% as measured by CGM and YSI*
    - Mean blood glucose value measured by CGM and YSI*
    - Percentage of time with glucose values in the range 3.9-8.0 mmol/l measured by CGM and YSI*
    - Percentage of time with glucose values in the range 3.9-10.0 mmol/l measured by CGM and YSI*
    - Percentage of time with glucose values in the range > 10.0 mmol/l measured by CGM and YSI*
    - Percentage of time with glucose values < 3.0 mmol/l as measured by CGM and YSI*
    - Number of hypoglycemic episodes overnight and during daytime*
    - Nadir blood glucose value for each hypoglycemic episode as measured by CGM and YSI
    - Duration of each hypoglycemic event as measured by YSI and CGM
    - CGM glycemic variability measured as SD and CV during overnight and during daytime*
    - Low Blood Glucose Index (LBGI) overnight and during daytime CGM*
    - Percentage of participants with a mean blood glucose value (YSI and CGM) ≤ 8.6 mmol/l (corresponding to an estimated HbA1c of 7.0% / 53 mmol/mol)
    - Percentage of patients with a mean blood glucose value (YSI and CGM) ≤ their standard therapy mean glucose value (calculated based on HbA1c measurement)
    - Mean Absolute Relative Difference (MARD) between CGM and YSI glucose*
    - Mean blood pressure over the study period
    - Mean pulse rate over the study period
    - Mean nausea level (VAS)
    - Mean insulin dose
    - Mean bolus insulin dose
    - Mean basal insulin dose
    - Mean glucagon dose
    - CHO counting ability (pictures vs. actual meals)
    - Self-assessment of glucose levels (Clarke Error Grid)
    - Raw acceleration measured by ActiGraph GT9X Link
    - Energy expenditure measured by ActiGraph GT9X Link
    - Steps taken measured by ActiGraph GT9X Link
    - Physical activity intensity measured by ActiGraph GT9X Link
    - Heart rate R-R intervals measured by ActiGraph GT9X Link
    - Sleep latency measured by ActiGraph GT9X Link
    - Total sleep time measured by ActiGraph GT9X Link
    - Sleep efficiency measured by ActiGraph GT9X Link
    - Mean Borg scale level during exercise
    - Diabetes Treatment Satisfaction Questionnaires, DTSQ
    - Diabetes Technology Questionnaire, DTQ
    - Hypoglycemia fear survey, HFS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation is performed after completion of the second study session, i.e. after two times 33-hours
    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 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) 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Automated glucose control with insulin only, i.e. without glucagon
    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 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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 13
    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 state13
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-19
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