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    Summary
    EudraCT Number:2020-001158-23
    Sponsor's Protocol Code Number:U1111-1243-4058
    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:2020-08-27
    Trial 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 number2020-001158-23
    A.3Full title of the trial
    Fast-Acting Insulin Aspart and Insulin Pump Settings:
    “THE FAST PUMP SETTING STUDY”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fast-Acting Insulin Aspart and Insulin Pump Settings:
    “THE FAST PUMP SETTING STUDY”
    A.4.1Sponsor's protocol code numberU1111-1243-4058
    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.4.1Name of organisation providing supportNovo Nordisk A/S
    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 pointKirsten Nørgaard
    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 number+4527131011
    B.5.6E-mailkirsten.noergaard@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 No
    D.2.1.1.1Trade name Fiasp
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    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.3.4Pharmaceutical 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 U/ml 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.IMP: 2
    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.2.1.1.1Trade name NovoRapid
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    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 nameNovorapid
    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 U/ml 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
    Type 1 diabetes
    E.1.1.1Medical condition in easily understood language
    Participants in this study have type 1 diabetes which is defined as lack of own insulin production
    Type 1 diabetes er en kronisk sygdom som er karakteriseret ved at man ikke kan producere insulin til at få blodglukose ned.
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10045228
    E.1.2Term Type I diabetes mellitus
    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
    To compare the CGM-derived time in range (3.9-10.0 mmol/l) during the last two weeks of the 16-week interventions with Fiasp versus NovoRapid
    E.2.2Secondary objectives of the trial
    To compare insulin pump settings when pumps are optimally adjusted to each of the two insulin types.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Age ≥ 18 years
     Type 1 diabetes for ≥ 5 years
     HbA1c 53-75 mmol/mol (7.0-9.0%)
     Insulin pump treatment for ≥ 6 months (all insulin pump makes except hybrid closed-loop systems are eligible for inclusion)
     CGM use for ≥ 6 months (all CGM makes are eligible for inclusion)
     Carbohydrate counting for all snacks and meals
     Use of the insulin pump bolus calculator for all meals and snacks
    E.4Principal exclusion criteria
     Breast-feeding, pregnant, planning to become pregnant or of child-bearing potential and not using adequate contraceptive methods
     Gastroparesis (clinical assessment)
     Shift work
     Changing insulin needs throughout the menstrual cycle that requires different basal rate patterns
     Use of a hybrid closed-loop system
     Use of flash glucose monitoring
     Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
     Chronic paracetamol use
     Alcohol or drug abuse
     Severe cardiac disease or retinopathy contraindicating HbA1c below 53 mmol/mol
     Impaired renal function (eGFR< 60 ml/min/1.73 m2)
     History of local skin reactions to Fiasp and/or Iasp
     Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
     Lack of compliance with key study procedures at the discretion of the investigator
     Unacceptable adverse events at the discretion of the investigator
     Less than 40 weeks guarantee remaining on insulin pump
    E.5 End points
    E.5.1Primary end point(s)
    Difference in CGM-derived time in range (3.9-10.0 mmol/l) during the interventions with Fiasp versus Novorapid
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the last two weeks of each 16-week interventions
    E.5.2Secondary end point(s)
    The following endpoints are assessed by CGM values downloads from the last two weeks of the 16-week treatment periods
     Difference between treatments in mean glucose
     Difference between treatments in coefficient of variation
     Difference between treatments in standard deviation
     Difference between treatments in percentage of time < 3.9 mmol/l
     Difference between treatments in percentage of time < 3.0 mmol/l
     Difference between treatments in percentage of time >10 mmol/l
     Difference between treatments in percentage of time > 13.9 mmol/l
     Difference between treatments in low blood glucose index
     Difference between treatments in high blood glucose index
     Difference between treatments in eHbA1c

    The following eight endpoints are based on insulin pump downloads from the last two weeks of the 16-week treatment periods
     Difference between treatments in total insulin dose#
     Difference between treatments in total basal insulin#
     Difference between treatments in total bolus insulin#
     Difference between treatments in basal/bolus-ratio#
     Difference between treatments in weighted ICRs*
     Difference between treatments in weighted ISF*
     Difference between treatments in mean number of boluses per day

     Difference between treatments in relation between daily carbohydrate intake and time in range

     Difference in change in fructosamine, cholesterol, HDL, LDL, triglycerides, sodium, potassium, creatinine, u-alb-crea ratio and TSH
     Difference in number of severe hypoglycemia events (cognitive impairment requiring external assistance for recovery)
     Difference in number of diabetic ketoacidosis events
     Difference in number of AEs
     Compliance with instruction to change insulin infusion set every 2nd day
    E.5.2.1Timepoint(s) of evaluation of this end point
    # indicates that the outcome will be calculated for the following time intervals: 12 AM – 12AM, 6 AM – 12 AM (wake), and 12 AM – 6 AM (sleep)
    * indicates that the outcome will be calculated for the following time intervals: 12 AM – 6 AM, 6 AM – 11 AM, 11 AM – 4 PM, 4 PM – 12 AM
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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 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
    LVLS
    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 months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Participants will return to their pre-study treatment
    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 Decision2020-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-06
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