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    Summary
    EudraCT Number:2010-021560-15
    Sponsor's Protocol Code Number:NN9068-3697
    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:2011-02-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-021560-15
    A.3Full title of the trial
    DUAL™ I DUal Action of Liraglutide and insulin degludec in type 2 diabetes A 26 week randomised, parallel three-arm, open-label, multi-centre, multinational treat-to-target trial comparing fixed ratio combination of insulin degludec and liraglutide versus insulin degludec or liraglutide alone, in subjects with type 2 diabetes treated with 1-2 oral anti-diabetic drugs (OADs) with a 26 week extension.
    Uno studio di 26 settimane, randomizzato, a tre bracci paralleli, in aperto, multicentrico, multinazionale, treat-to-target, che confronta una combinazione in rapporto fisso di insulina degludec e liraglutide versus l’insulina degludec o il liraglutide da soli, in soggetti con diabete di tipo 2 trattati con 1-2 farmaci anti-diabetici orali (OAD)con un` estensione di 26 settimane.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    -
    .
    A.3.2Name or abbreviated title of the trial where available
    DUAL™ I
    DUAL™ I
    A.4.1Sponsor's protocol code numberNN9068-3697
    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
    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 A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Noridsk
    B.5.2Functional name of contact pointCMR Department
    B.5.3 Address:
    B.5.3.1Street AddressVia Elio Vittorini 129
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00144
    B.5.3.4CountryItaly
    B.5.4Telephone number0650088350
    B.5.5Fax number065021650
    B.5.6E-mailmgia@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 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 nameInsulin degludec/Liraglutide
    D.3.2Product code NNC 0100-0454/ NNC 90-1170
    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 INNCombinations
    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 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 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 nameInsulin degludec
    D.3.2Product code NNC 0100-0454
    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 degludec
    D.3.9.1CAS number 844439-96-9
    D.3.9.2Current sponsor codeNNC 0100-0454
    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 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: 3
    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 VICTOZA
    D.2.1.1.2Name of the Marketing Authorisation holderNOVO NORDISK FARMACEUTICI SpA
    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.3.4Pharmaceutical 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 INNNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 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 2 diabetes
    diabete di tipo 2
    E.1.1.1Medical condition in easily understood language
    .
    .
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II 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
    To confirm the efficacy of insulin degludec/liraglutide in controlling glycaemia in subjects with type 2 diabetes. This is done by comparing the difference in change in HbA1c from baseline after 26 weeks of treatment to a noninferiority limit of 0.3% for insulin degludec/liraglutide vs insulin degludec and to a superiority limit of 0% for insulin degludec/liraglutide vs liraglutide
    Confermare l'efficacia di insulina degludec/liraglutide nel controllo glicemico del paziente diabetico di tipo 2. Cio' viene effettuato mettendo a confronto la differenza nel cambiamento del valore dell' HbA1c alla baseline e dopo 26 settimane di trattamento con un limite di non inferiorita' dello 0.3% per insulina degludec/liraglutide versus insulina degludec e con un limite di superiorita' dello 0% per l'insulina degludec/liraglutide versus liraglutide.
    E.2.2Secondary objectives of the trial
    1 - To confirm superiority of insulin degludec/liraglutide vs insulin degludec after 26 weeks of treatment on either weight control, hypoglycaemic episodes, glycaemic control in relation to a meal, or glycaemic control as indirectly measured by daily dose of insulin degludec 2 - To compare general efficacy and safety of degludec/liraglutide, insulin degludec and liraglutide after 26 weeks of treatment - 3 - to confirm the efficacy of insulin degludec/liraglutide in controlling glycaemia in subjects with type 2 diabetes after 52 weeks of treatment.
    1- Confermare la superiorita` dell`insulina degludec/liraglutide versus insulina degludec dopo 26 settimane di trattamento sul controllo del peso,sugli episodi di ipoglicemia,il controllo glicemico in relazione ai pasti o il controllo glicemico misurato indirettamente dalla dose giornaliera di insulina degludec.2- Mettere a confronto l`efficacia e la sicurezza di insulina degludec/liraglutide,insulina degludec e liraglutide dopo 52 settimane di trattamento.- 3- confermare l`efficacia dell`insulina degludec/liraglutide nel controllo della glicemia in soggetti con diabete di tipo 2 dopo 52 settimane di trattamento.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    See Addendum to protocol version 2.0 final date 15 Dec 2010.

    ALTRI SOTTOSTUDI:
    Il sottostudio (Addendum al protocollo Versione 2.0 Final del 15 Dec 2010)prevede l`esecuzione del monitoraggio continuo del glucosio (CGM) e meal test per una sottopopolazione di pazienti.

    E.3Principal inclusion criteria
    Subjects with type 2 diabetes • HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3% • Male or female, age 18 years or above • Subjects on stable dose of 1-2 OADs (metformin [`‰¥ 1500 mg or max tolerated dose] or metformin [`‰¥ 1500 mg or max tolerated dose] + pioglitazone [`‰¥ 30 mg]) for at least 90 days prior to screening • BMI `‰¤ 40 kg/m^2
    1 - HbA1c 7.0-10.0 % (entrambi inclusi) con l'obiettivo di una mediana HbA1c di 8.3%. Quindi nel momento in cui circa il 50% dei soggetti randomizzati presenti valori di HbA1c sopra 8.3%, i rimanenti soggetti randomizzati presentereanno valori di HbA1c inferiori o uguali a 8.3%. Viceversa nel momento in cui il 50% di soggetti randomizzati presenti valori di HbA1c inferiori o uguali a 8.3%, la parte rimanente dei soggetti randomizzati presentera` valori di HbA1c superiori a 8.3%. 2 -Maschi o Femmine di eta` superiore ai 18 anni. 3 -Soggetti trattati con 1-2 OAD a dosaggio stabile (metformina [maggiore o uguale 1.500 mg o dose massima tollerata] o metformina [maggiore o uguale 1.500 mg o dose massima tollerata] + pioglitazone [maggiore o uguale 30 mg]) per almeno 90 giorni prima della screening. 4 - BMI inferiore o uguale 40 kg/m2
    E.4Principal exclusion criteria
    • Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator) • Treatment with GLP-1 receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial • Impaired liver function, defined as alanine aminotransferese (ALAT) `‰¥ 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive) • Impaired renal function defined as serum-creatinine `‰¥ 133 µmol/l (`‰¥ 1.5 mg/dl) for males and `‰¥ 125 µmol/l (`‰¥ 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive) • Screening calcitonin `‰¥ 50 ng/L • Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) • Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures • Severe uncontrolled treated or untreated hypertension (systolic blood pressure `‰¥ 180 mm Hg or diastolic blood pressure `‰¥ 100 mm Hg) • Acute treatment required proliferative retinopathy or maculopathy (macular oedema) • History of chronic pancreatitis or idiopathic acute pancreatitis
    1 - Trattamento con insulina (eccetto in caso di trattamenti a breve termine dovuti a malattie intercorrenti a discrezioen del medico) 2 - Trattamento con agonisti del recettore GLP-1 ( es. exenatide, liraglutide), sulfanilurea o inibitori della dipeptyl peptidasi 4 (DPP-4)entro 90 giorni prima dell`inizio dello studio. 3 - funzionalita` epatica compromessa, definita come alanina aminostrasferasi (ALAT)maggiore o uguale 2.5 volte il Range di Noralita` piu` alto (UNR)(e` permessa un`analisi re-test effettuata presso il laboratorio centrlizzato entro uan settimana dal primo campione prelevato. Il risultato dell`ultimo campione risultera` quello definitivo). 4 - Funzione renale compromessa definita come livelli di creatinina nel siero maggiore o uguale 133 µmol/l (maggiore o uguale 1.5 mg/dl) per gli uomini and maggiore o uguale 125 µmol/l (maggiore o uguale 1.4) per le donne, o secondo quando permesso dalle controindicazioni locali per il trattamento con metformina (e` permessa un`analisi re-test effettuata presso il laboratorio centrlizzato entro uan settimana dal primo campione prelevato. Il risultato dell`ultimo campione riusltera` quello definitivo) 5 - Livelli di calcitonina allo screening maggiore o uguale 50 ng/L 6 - soggetti con storia personale o familiare di carcinoma medullare della tiroide (MTC) o di neoplasia endocrina multipla di tipo 2 (MEN-2) 7 - disordini a livello Caridaco definiti come: Insufficienza cardiaca congestiva (NYHA classe III-IV), diagnosi di angina pectoris instabile, ischemia cerebrale e/o infarto del miocardio negli ultimi dodici mesi e la pianificazione di procedure di rivascolarizzazione delle coronarie, carotidi o arterie periferiche. 8 - Ipertensione grave trattata o non trattata (pressione sistolica maggiore o uguale 180 mm Hg o pressione diastolica maggiore o uguale 100 mm Hg) 9 - Retinopatia proliferativa che richieda trattamento acuto o maculopatia (edema maculare) 10 - Storia di pancreatite cronica o pancreatite acuta idiopatica.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baselinein HbA1c after 26 weeks of treatment.
    Cambiamento del valore di HbA1c dalla baseline dopo 26 settimane di trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    .
    .
    E.5.2Secondary end point(s)
    .
    .
    E.5.2.1Timepoint(s) of evaluation of this end point
    .
    .
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    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 trial3
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA72
    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
    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 months16
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-02-07. Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 442
    F.4.2.2In the whole clinical trial 1660
    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)
    n.a.
    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 Decision2011-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-19
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