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    Summary
    EudraCT Number:2016-000878-38
    Sponsor's Protocol Code Number:NN1218-4113
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-000878-38
    A.3Full title of the trial
    Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® both in Combination with Insulin Degludec with or without Metformin in Adults with Type 2 Diabetes
    Efficacia e Sicurezza dell' insulina ad azione rapida Aspart in confronto a NovoRapid® in combinazione all' insulina Degludec, con o senza Metformina, in soggetti adulti con diabete tipo 2 (Onset® 9)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study comparing a new medicine "fast-acting insulin aspart" to another already available medicine NovoRapid® in people with type 2 diabetes
    Studio di ricerca che confronta un nuovo prodotto "insulina aspart ad azione rapida " a NovoRapid®, un farmaco già in commercio, in persone con diabete tipo 2
    A.3.2Name or abbreviated title of the trial where available
    onset® 9
    onset® 9
    A.4.1Sponsor's protocol code numberNN1218-4113
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1180-0636
    A.5.4Other Identifiers
    Name:NN1218-4113Number:NN1218-4113
    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 SponsorNOVO NORDISK. S.P.A.
    B.1.3.4CountryItaly
    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 supportNovo Nordisk
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointGlobal Clinical Registry (GCR,1452)
    B.5.3 Address:
    B.5.3.1Street AddressNovo Allè
    B.5.3.2Town/ cityBagsværd
    B.5.3.3Post code2880
    B.5.3.4CountryDenmark
    B.5.4Telephone number.
    B.5.5Fax number.
    B.5.6E-mailclinicaltrials@novonordisk.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 Yes
    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 AuthorisationEuropean Union
    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 nameFast acting insulin aspart
    D.3.2Product code [N/A]
    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 INNInsulin Aspart
    D.3.9.1CAS number 116094-23-6
    D.3.9.2Current sponsor codeNN1218
    D.3.9.3Other descriptive nameINSULIN ASPART
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name NOVORAPID - PENFILL 100 U/ML SOLUZIONE INIETTABILE 10 CARTUCCE 3 ML USO SOTTOCUTANEO
    D.2.1.1.2Name of the Marketing Authorisation holderNOVO NORDISK A/S
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.2Product code [N/A]
    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 INNINSULINA ASPART
    D.3.9.1CAS number 116094-23-6
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameINSULINA ASPART
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 3
    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 TRESIBA - 100U/ML-SOLUZIONE INIETTABILE-USO SOTTOCUTANEO-PENNA PRE-RIEMPITA (VETRO) (FLEXTOUCH)-3 ML - 1 PENNA PRE-RIEMPITA
    D.2.1.1.2Name of the Marketing Authorisation holderNOVO NORDISK A/S
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nametresiba
    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 INNINSULINA DEGLUDEC
    D.3.9.1CAS number 844439-96-9
    D.3.9.2Current sponsor codeNN1250
    D.3.9.3Other descriptive nameINSULIN DEGLUDEC
    D.3.9.4EV Substance CodeSUB96394
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Diabetes Mellitus, Type 2
    Diabete mellito, tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    Diabete tipo 2
    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 10045242
    E.1.2Term Type II 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 confirm the effect in terms of glycaemic control of treatment with fast-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec with or without metformin in adults with type 2 diabetes treated with a basal-bolus regimen, using a non-inferiority approach.
    Confermare l' effetto in termini di controllo glicemico del trattamento con insulina Aspart ad azione rapida rispetto all' insulina NovoRapid®, entrambe in combinazione con insulina degludec, con o senza metformina, in adulti con diabete mellito tipo 2 trattati in regime basal-bolus, utilizzando un approccio di non inferiorità
    E.2.2Secondary objectives of the trial
    1. To confirm superiority of fast-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec with or without metformin in adults with type 2 diabetes treated with a basal-bolus regimen in terms of:
    - Postprandial glucose regulation
    - Overall glycaemic control
    - Postprandial glucose excursions

    2. To compare the safety of fast-acting insulin aspart to NovoRapid¿ both in combination with insulin degludec with or without metformin in adults with type 2 diabetes treated with a basal-bolus regimen.
    1 - Confermare la superiorità dell' insulina Aspart ad azione rapida rispetto all'insulina NovoRapid®, entrambe in combinazione con insulina degludec, con o senza metformina, in adulti con diabete mellito di tipo 2 trattati in regime basale-bolo, in termini di:
    - Regolazione della glicemia postprandiale
    - Controllo generale della glicemia
    - Escursioni glicemiche postprandiali

    2 - Confrontare la sicurezza dell' insulina Aspart ad azione rapida rispetto a NovoRapid®, entrambe in combinazione con insulina degludec, con o senza metformina, in adulti con diabete mellito tipo 2 trattati in regime basal-bolus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, age = 18 years at the time of signing informed consent.
    - Diagnosed with type 2 diabetes = 10 years prior to screening (Visit 1).
    - Treated with a basal-bolus insulin regimen =1 year prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times daily. Treatment with premixed insulin or soluble insulin combination is not considered a basal-bolus regimen.
    - Treated with or without oral antidiabetic drugs including extended release formulations.
    - HbA1c 7.0 - 10.0% (both inclusive) as assessed by central laboratory at screening (Visit 1).

    Randomisation criterion:
    - HbA1c = 9.0% measured by the central laboratory at Visit 13 (week -1).
    - Sesso maschile o femminile, = 18 anni di età al momento della firma del modulo di consenso informato
    - Soggetti che hanno ricevuto diagnosi di diabete mellito tipo 2 = 10 anni prima del giorno dello screening (Visita 1).
    - Trattamento con regime insulinico basal-bolus da = 1 anno prima della Visita di screening (Visita 1). Un regime insulinico basal-bolus è definito come trattamento con insulina basale una o due volte al giorno e un bolo di un analogo di insulina da assumere ai pasti almeno 3 volte al giorno. Il trattamento con insulina pre-miscelata o combinazioni di insulina solubili non sono considerati come regime basal-bolus.
    - Trattamento con o senza farmaci antidiabetici orali, incluse le formulazioni a rilascio prolungato.
    - HbA1c 7,0 -10,0% (estremi compresi) misurati dal laboratorio centrale allo screening (Visita 1).


    Criterio di randomizzazione:
    HbA1c = 9,0% valutata dal laboratorio centrale alla Visita 13 (settimana -1).
    E.4Principal exclusion criteria
    - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1).
    - Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
    - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (Visit 1).
    - Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1).
    - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
    - Uno qualsiasi dei seguenti eventi: infarto del miocardio, ictus, ricovero in ospedale per angina instabile o attacco ischemico transitorio (TIA) nei 180 giorni precedenti al giorno dello screening (Visita 1).
    - Soggetti attualmente classificati nella Classe IV della New York Heart Association (NYHA).
    - Rivascolarizzazione arteriosa coronarica, carotidea o periferica programmata, nota il giorno dello screening (Visita 1).
    - Trattamento con agonisti del recettore di GLP-1 iniettabili nel periodo di 90 giorni prima della visita dello screening (Visita 1).
    - Previsto inizio o variazione nell’assunzione di farmaci concomitanti (per oltre 14 giorni consecutivi) per i quali è nota l’influenza sul peso o sul metabolismo glicemico (ad es., trattamento con orlistat, ormoni tiroidei, corticosteroidi).
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in HbA1c
    Variazione rispetto al basale dei valori di emoglobina glicata (HbA1c)
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks after randomisation
    16 settimane dopo la randomizzazione
    E.5.2Secondary end point(s)
    1. Change from baseline in 1-hour postprandial glucose increment (meal
    test)
    2. Change from baseline in 1,5-anhydroglucitol
    ¿ Variazione rispetto al basale dell¿incremento della glicemia postprandiale misurata 1 ora dopo il pasto (test del pasto)
    ¿ Variazione rispetto al basale dell¿ 1,5-anidroglucitolo
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.-2. 16 weeks after randomisation
    1-2 - 16 settimane dopo la randomizzazione
    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 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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Treat to target
    Treat-to-target
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Korea, Republic of
    Russian Federation
    Serbia
    Ukraine
    United States
    European Union
    Argentina
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days17
    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: 965
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 107
    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 Yes
    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 state47
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 471
    F.4.2.2In the whole clinical trial 1262
    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
    Non applicabile
    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 Decision2017-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
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