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    Summary
    EudraCT Number:2010-021560-15
    Sponsor's Protocol Code Number:NN9068-3697
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-12
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-021560-15
    A.3Full title of the trial
    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
    Estudio de 26 semanas, randomizado, de 3 brazos paralelos, abierto, multicéntrico, multinacional de ajuste de dosis para comparar una combinación en proporción fija de liraglutida e insulina degludec frente a insulina degludec o liraglutida solas en pacientes con diabetes tipo 2 tratados con 1-2 antidiabéticos orales (ADOs) con una extensión de 26 semanas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dual action of liraglutide and insulin degludec in type 2 diabetes: A trial comparing the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide in subjects with type 2 diabetes
    A.3.2Name or abbreviated title of the trial where available
    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 A/S
    B.1.3.4CountryDenmark
    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 Nordisk A/S
    B.5.2Functional name of contact pointGlobal Clinical Registry (GCR,1452)
    B.5.3 Address:
    B.5.3.1Street AddressVandtaarnsvej 114, VTB
    B.5.3.2Town/ citySoeborg
    B.5.3.3Post codeDK-2860
    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 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 INNInsulin degludec
    D.3.9.1CAS number 844439-96-9
    D.3.9.2Current sponsor codeNNC 0100-0454
    D.3.9.3Other descriptive nameInsulin 454
    D.3.10 Strength
    D.3.10.1Concentration unit EID50/dose 50% Embryo Infective Dose/dose
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLiraglutide
    D.3.9.1CAS number 204656-20-2
    D.3.9.2Current sponsor codeNN 90-1170
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.6
    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.2.5The 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.3.9.3Other descriptive nameInsulin 454
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    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: 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 6 mg/ml solución inyectable en pluma precargada
    D.2.1.1.2Name of the Marketing Authorisation holderNOVO NORDISK A/S
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameLiraglutide
    D.3.2Product code NNC
    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 INNLIRAGLUTIDA
    D.3.9.3Other descriptive nameLIRAGLUTIDA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.0
    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 2 diabetes
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    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 PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 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 non-inferiority limit of 0.3% for insulin degludec/liraglutide vs insulin degludec and to a superiority limit of 0% for insulin degludec/liraglutide vs liraglutide.
    Confirmar la eficacia de insulina degludec/liraglutida para el control de la glucemia en pacientes con diabetes tipo 2.

    A este fin, se comparará la diferencia en el cambio en la HbA1c con respecto al valor basal después de 26 semanas de tratamiento con un límite de no inferioridad del 0,3% para insulina degludec/liraglutida frente a insulina degludec y un límite de superioridad del 0% para insulina degluded/liraglutida frente a liraglutida
    E.2.2Secondary objectives of the trial
    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
    To compare general efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide after 26 and 52 weeks of treatment
    To confirm the efficacy of insulin degludec/liraglutide in controlling glycaemia in subjects with type 2 diabetes after 52 weeks of treatment
    Confirmar la superioridad de insulina degludec/liraglutida frente a la insulina degludec después de 26 semanas de tratamiento bien con respecto al control del peso corporal y los episodios de hipoglucemia, control glucémico en relación con una comida o control glucémico indirectamente medido por dosis diarias de insulina degludec.
    Confirmar la eficacia de insulina degludec/liraglutida para el control de la glucemia en pacientes con diabetes tipo 2 después de 52 semanas de tratamiento
    Comparar la eficacia general y la seguridad de insulina degludec/liraglutida, insulina degludec y liraglutida después de 26 y 52 semanas de tratamiento
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Titulo:Documento adjunto para el subestudio del ensayo clínico NN9068-3697
    Fecha: 09 de Junio de 2011
    Versión 2.0
    Objectivo:
    Confirmar la superioridad de insulina degludec/liraglutida frente a insulina degludec después de 52 semanas de tratamiento en el control glucémico en relación con una comida y comparar la eficacia general y la seguridad de insulina degludec/liraglutida, insulina degludec y liraglutida después de 52 semanas de tratamiento
    E.3Principal inclusion criteria
    Pacientes con diabetes tipo 2
    HbA1c: 7,0-10,0 % (ambos inclusive) con el objetivo de una media de HbA1c del 8.3%. Consecuentemente cuando aproximadamente el 50% de los sujetos randomizados tengan una . HbA1c por encima de 8.3%, el resto de sujetos que queden por randomizar deberán tener una HbA1c por debajo o igual a 8.3%, o cuando aproximadamente el 50% de los pacientes randomizados tengan una HbA1c por debajo o igual al 8.3%, el resto de pacientes que queden por randomizar deberán tener una HbA1c por encima de 8.3%.
    Hombres o mujeres de 18 o más años de edad
    Pacientes con una dosis estable de uno o dos ADO (metformina [ > ó = 1.500 mg o la dosis máxima tolerada] o metformina [> ó = 1.500 mg o la dosis máxima tolerada] + pioglitazona [> ó = 30 mg]) durante al menos 90 días antes de la visita de selección
    IMC < ó = 40 Kg/m2

    - 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 [>or = 1500 mg or max tolerated dose] or metformin [> or = 1500 mg or max tolerated dose] + pioglitazone [> or = 30 mg]) for at least 90 days prior to screening
    -BMI < or = 40 kg/m^2
    E.4Principal exclusion criteria
    Tratamiento con insulina (excepto tratamientos cortos debidos a enfermedades intercurrentes, a juicio del investigador)
    Tratamiento con agonistas de receptores GLP-1( ej exenatida, liraglutida),sulfonilureas o inhibidores de la dipeptidilo peptidasa 4 (DPP-4) en los 90 día anteriores al inicio del ensayo clínico
    Alteraciones de la función hepática, definidas como niveles de alanina aminotransferasa (ALAT) > ó = 2,5 veces el límite normal superior (LNS) (se permite volver a realizar la prueba en el laboratorio central en el plazo máximo de una semana a contar desde la obtención de la primera muestra, en cuyo caso se considerará que el resultado definitivo es el segundo)
    Alteraciones de la función renal que se define como una concentración sérica de creatinina > ó = 133 micromol/l (> ó = 1,5 mg/dl) para los hombres y > ó = 125 micromol/l ( 1,4) para las mujeres, o la concentración que se permita según las contraindicaciones de cada país de la metformina (se permite realizar una segunda prueba en el laboratorio central en el plazo máximo de una semana a contar desde la obtención de la primera muestra, en cuyo caso el resultado definitivo será el segundo)
    Calcitonina en la visita de selección > ó = 50 ng/L
    Pacientes con antecedentes personales o familiares de carcinoma medular de tiroides (CMT) o de neoplasia endocrina múltiple tipo 2 (NEM-2)
    Cardiopatía, que se define como insuficiencia cardíaca congestiva (clase III-IV de la NYHA) diagnóstico de angina de pecho inestable, accidente cerebrovascular y/o infarto de miocardio en los 12 meses anteriores o procedimientos programados de revascularización coronaria, carotídea o de las arterias periféricas.
    Hipertensión arterial grave y no controlada, tratada o no tratada (presión arterial sistólica > ó = 180 mmHg o presión arterial diastólica > ó = 100 mmHg)
    Tratamiento agudo requerido para retinopatía proliferativa o maculopatía (edema macular)
    Antecedentes de pancreatitis crónica o de pancreatitis aguda idiopática.

    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) > or = 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 > or = 133 micromol/l > or = 1.5 mg/dl) for males and > or = 125 micromol/l (> or = 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 > or = 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 > or = 180 mm Hg or diastolic blood pressure > or = 100 mm Hg)
    Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
    History of chronic pancreatitis or idiopathic acute pancreatitis
    micro
    E.5 End points
    E.5.1Primary end point(s)
    Cambio en los niveles basales de HbA1c después de 26 semanas de tratamiento
    Change from baseline in HbA1c after 26 weeks of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    después de 26 semanas de tratamiento
    after 26 weeks of treatment
    E.5.2Secondary end point(s)
    To confirm superiority of insulin degludec/liraglutide vs. insulin degludec the following confirmatory endpoints will be used:
    ?Change from baseline in body weight after 26 weeks of treatment
    ?Number of severe or minor hypoglycaemic episodes after 26 weeks of treatment
    ?Change from baseline in incremental AUC0-4h (iAUC 0-4h) derived from the glucose concentration profile during meal test after 26 weeks of treatment (see sub-study addendum)
    ?Daily insulin dose after 26 weeks of treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 26 weeks of treatment
    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 concerned8
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    India
    Malaysia
    Mexico
    Russian Federation
    Singapore
    South Africa
    Taiwan
    Thailand
    United States
    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
    LPLV
    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 days7
    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 days7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 880
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 780
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 422
    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 Decision2011-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-22
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