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    The EU Clinical Trials Register currently displays   43916   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-003406-11
    Sponsor's Protocol Code Number:NN1436-4465
    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:2019-04-12
    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 number2018-003406-11
    A.3Full title of the trial
    A trial comparing NNC0148-0287 C (insulin 287) versus insulin glargine U100, both in combination with metformin, with or without DPP4 inhibitors and with or without SGLT2 inhibitors, in insulin-naïve subjects with type 2 diabetes mellitus
    Ensayo comparando NNC0148-0287 C (insulina 287) frente a insulina glargina U100, ambos en combinación con metformina, con o sin tratamiento con inhibidores de DPP-4 y con o sin tratamiento con inhibidores de SGLT2, en sujetos con diabetes mellitus tipo 2 sin tratamiento previo con insulina.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to compare two types of insulin: insulin 287 and insulin glargine in people with type 2 diabetes who have not used insulin before
    Estudio de investigación para comparar dos tipos de insulina: insulina 287 e insulina glargina, en personas con diabetes tipo 2 que no han utilizado insulina con anterioridad
    A.4.1Sponsor's protocol code numberNN1436-4465
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1219-5474
    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 pointClinical Disclosure (1452)
    B.5.3 Address:
    B.5.3.1Street AddressNovo Allé
    B.5.3.2Town/ cityBagsvaerd
    B.5.3.3Post code2880
    B.5.3.4CountryDenmark
    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.3.2Product code NNC0148-0287 C 4200 nmol/mL
    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 INNN/A
    D.3.9.1CAS number *MASKED*
    D.3.9.3Other descriptive nameINSULIN 287
    D.3.9.4EV Substance CodeSUB50453
    D.3.10 Strength
    D.3.10.1Concentration unit nmol/ml nanomole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4200
    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 Yes
    D.2.1.1.1Trade name Lantus 100 U/mL
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis
    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.3.4Pharmaceutical 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 Glargine
    D.3.9.1CAS number 160337-95-1
    D.3.9.3Other descriptive nameINSULIN GLARGINE
    D.3.9.4EV Substance CodeSUB08196MIG
    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
    Diabetes Mellitus, Type 2
    Diabetes mellitus tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    Diabetes 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 20.1
    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 compare the effect on glycaemic control of once weekly insulin 287 using 3 different titration algorithms, versus once daily insulin glargine U100, both in combination with metformin ± DPP4i ± SGLT2i in insulin-naïve T2DM subjects
    Evaluar el efecto sobre el control de la glucemia de la insulina 287 administrada una vez a la semana, utilizando 3 algoritmos diferentes de ajuste de la dosis, en comparación con la insulina glargina U100 una vez al día, ambas en combinación con metformina ± iDPP4 ± SGLT2, en pacientes con diabetes mellitus tipo2 no tratados previamente con insulina
    E.2.2Secondary objectives of the trial
    To compare the safety and tolerability of once weekly insulin 287 using 3 different titration algorithms versus once daily insulin glargine U100 both in combination with metformin ± DPP4i ± SGLT2i in insulin-naïve T2DM subjects
    Evaluar el efecto sobre la seguridad y la tolerabilidad de la insulina 287 administrada una vez a la semana, utilizando 3 algoritmos diferentes de ajuste de la dosis, en comparación con la insulina glargina U100 una vez al día, ambas en combinación con metformina ± iDPP4 ± SGLT2, en pacientes con diabetes mellitus tipo2 no tratados previamente con insulina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
    2. Diagnosed with type 2 diabetes mellitus 180 days or longer prior to the day of screening.
    3. HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory.
    4. Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regime(s):
    a. Any metformin formulations equal to or above 1500 mg or maximum tolerated or effective dose (as documented in subject’s medical records)
    b. Free or fixed combination therapy: Metformin as outlined above with or without DPP4i with or without SGLT2i is allowed:
    b. 1: DPP4i (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose)
    b.2: SGLT2i (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose )
    5. Insulin-naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
    6. Body mass index (BMI) equal to or above 40.0 kg/m^2
    1. Varón o mujer de 18 75 años (ambos inclusive) en el momento de firmar el documento de consentimiento informado.
    2. Diagnóstico de diabetes mellitus tipo 2 ≥180 días antes del día de la selección.
    3. HbA1c del 7,0% 10,0% (53,0 85,8 mmol/mol) (ambos inclusive) evaluada por el laboratorio central.
    4. Dosis diaria estable de los siguientes antidiabéticos o pautas combinadas durante 90 días antes del día de la selección:
    a. Cualquier formulación de metformina ≥1500mg o a la dosis máxima tolerada o la dosis efectiva (lo que esté documentado en la historia clínica del paciente).
    b. Terapia de combinación libre o fija: se permite metformina como se describe anteriormente ± DPP4i ± SGLT2i:
    b.1. DPP4i (≥ la mitad de la dosis máxima aprobada según la etiqueta local o la dosis máxima tolerada o efectiva)
    b.2. SGLT2i (≥ la mitad de la dosis máxima aprobada según la etiqueta local o la dosis máxima tolerada o efectiva)
    5. Sin tratamiento previo con insulina. No obstante, se permite un tratamiento con insulina de corta duración durante un máximo de 14 días previos al día de la selección, así como el tratamiento previo con insulina para la diabetes gestacional.
    6. Índice de masa corporal (IMC) ≤40,0kg/m2.
    E.4Principal exclusion criteria
    1. Known or suspected hypersensitivity to trial product(s) or related products.
    2. Previous participation in this trial. Participation is defined as signed informed consent.
    3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.
    4. Participation in any clinical trial, of an approved or non-approved investigational medicinal product within 90 days before screening.
    5. Any disorder, except for conditions associated with type 2 diabetes mellitus, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
    6. Any episodes of diabetic ketoacidosis within the past 90 days, prior to the day of screening and between screening and randomisation.
    7. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and randomisation.
    8. Presently classified as being in New York Heart Association (NYHA) Class IV.
    9. Planned coronary, carotid or peripheral artery revascularisation between screening and randomisation.
    10. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR below 60 ml/min/1.73 m^2 as defined by KDIGO 2012.
    11. Impaired liver function, defined as Alanine Aminotransferase (ALT) equal to or above 2.5 times or Bilirubin above 1.5 times upper normal limit at screening.
    12. Inadequately treated blood pressure, defined as Grade 3 hypertension or higher (Systolic equal to or above 180 mmHg or diastolic equal to or above 110 mmHg) at screening.
    13. Treatment with any medication for the indication of diabetes, or obesity other than stated in the inclusion criteria within the past 90 days, prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
    14. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
    15. Presence or history of malignant neoplasms within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
    1. Hipersensibilidad conocida o sospechada a los productos de investigación o productos relacionados.
    2. Participación previa en este ensayo. La participación se define como la firma del consentimiento informado.
    3. Mujeres embarazadas, que estén en periodo de lactancia o que tengan intención de quedarse embarazadas o que estando en edad fértil no utilicen un método anticonceptivo adecuado.
    4. Participación en cualquier ensayo clínico de un medicamento en investigación aprobado o no aprobado dentro de los 90 días anteriores a la selección.
    5. Cualquier trastorno, excepto las afecciones asociadas con la diabetes mellitus tipo 2, que en opinión del investigador puedan poner en peligro la seguridad del sujeto o el cumplimiento del protocolo.
    6. Cualquier episodio de cetoacidosis diabética en los últimos 90 días, antes del día de la selección y entre la selección y la aleatorización.
    7. Infarto de miocardio, ictus, hospitalización por angina inestable o accidente isquémico transitorio en los 180 días previos a la selección y durante selección y aleatorización.
    8. Actualmente clasificado en la clase IV de la New York Heart Association (NYHA).
    9. Revascularización planificada de la arteria coronaria, carótida o periférica entre la selección y aleatorización.
    10. Insuficiencia renal medida como el valor estimado de la tasa de filtración glomerular (eGFR) de eGFR por debajo de 60 ml / min / 1.73 m ^ 2, según lo define KDIGO 2012.
    11. Deterioro de la función hepática, definida como alanina aminotransferasa (ALT) igual o superior a 2,5 veces o bilirrubina por encima de 1,5 veces el límite superior de la normalidad en la selección.
    12. Presión arterial tratada de manera inadecuada, definida como hipertensión de grado 3 o superior (sistólica igual o superior a 180 mmHg o diastólica igual o superior a 110 mmHg) en la selección.
    13. Tratamiento con cualquier medicamento para la indicación de diabetes u obesidad que no se indique en los criterios de inclusión en los últimos 90 días, antes de la selección. Sin embargo, se permite el tratamiento con insulina a corto plazo durante un máximo de 14 días antes del día de la selección, al igual que el tratamiento previo con insulina para la diabetes gestacional.
    14. Retinopatía diabética o maculopatía no controlada y potencialmente inestable. Verificado por un examen de fondo de ojo realizado en los últimos 90 días antes de la selección o en el período entre la selección y la aleatorización. La dilatación farmacológica de la pupila es un requisito a menos que se utilice una cámara fotográfica digital de fondo de ojo especificada para el examen sin dilatación.
    15. Presencia o antecedentes de neoplasias malignas dentro de los 5 años anteriores al día de la selección. Se permiten el cáncer de piel de células basales y de células escamosas y cualquier carcinoma in situ.
    E.5 End points
    E.5.1Primary end point(s)
    Time in target range 3.9–10.0 mmol/L (70-180 mg/dL) measured using continuous glucose monitoring (CGM)
    Tiempo en el rango objetivo 3.9-10.0 mmol / L (70-180 mg / dL) medido usando el medidor continuo de glucosa (CGM)
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the last 2 weeks of treatment (week 15 and 16)
    Durante las últimas 2 semanas de tratamiento (semanas 15 y 16)
    E.5.2Secondary end point(s)
    1. Change in HbA1c
    2. Change in fasting plasma glucose (FPG)
    3. Change in body weight
    4. Weekly insulin dose
    5. Number of treatment emergent adverse events (TEAEs)
    6. Number of severe hypoglycaemic episodes (level 3)
    7. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
    8. Number of hypoglycaemic alert episodes (level 1) (equal to or above 3.0 and below 3.9 mmol/L (equal to or above 54 and below 70 mg/dL), confirmed by BG meter)
    1. Cambio en la HbA1c
    2. Cambio en la glucosa plasmática en ayunas (FPG)
    3. Cambio en el peso corporal
    4. Dosis semanal de insulina
    5. Número de eventos adversos emergentes del tratamiento (TEAEs)
    6. Número de episodios hipoglucémicos graves (nivel 3)
    7. Número de episodios de hipoglucemia clínicamente significativos (nivel 2) (por debajo de 3.0 mmol / L (54 mg / dL), confirmados por glucómetro) o episodios de hipoglucemia grave (nivel 3)
    8. Número de episodios de alerta de hipoglucemia (nivel 1) (igual o superior a 3,0 e inferior a 3,9 mmol / L (igual o superior a 54 e inferior a 70 mg / dL), confirmado por un glucómetro)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.-3. From baseline week 0 (V2) to week 16 (V18)
    4. During the last 2 weeks of treatment (week 15 and 16)
    5. From baseline week 0 (V2) to week 21 (V20)
    6.-8. From baseline week 0 (V2) to week 16 (V18)
    1.-3. Desde la semana basal 0 (V2) hasta la semana 16 (V18)
    4. Durante las últimas 2 semanas de tratamiento (semanas 15 y 16)
    5. Desde la semana basal 0 (V2) hasta la semana 21 (V20)
    6.-8. Desde la semana basal 0 (V2) hasta la semana 16 (V18)
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    European Union
    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
    LVLS
    UVUP
    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 months8
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days14
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 200
    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
    Ninguno
    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 Decision2019-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-17
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