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    The EU Clinical Trials Register currently displays   36377   clinical trials with a EudraCT protocol, of which   5993   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2011-002605-29
    Sponsor's Protocol Code Number:NN2211-3659
    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:2012-06-22
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-002605-29
    A.3Full title of the trial
    Efficacy and safety of liraglutide in combination with metformin versus metformin monotherapy on glycaemic control in children and adolescents with type 2 diabetes
    Eficacia y seguridad de liraglutida en combinación con metformina en comparación con metformina en monoterapia en el control de la glucemia en niños y adolescentes con diabetes de tipo 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of liraglutide in combination with metformin compared to metformin alone, in children and adolescents with type 2 diabetes.
    Eficacia y seguridad de liraglutida en combinación con metformina comparado sólo con metformina en niños y adolescentes con diabetes de tipo 2
    A.4.1Sponsor's protocol code numberNN2211-3659
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1121-8743
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/102/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovo Nordisk A/S
    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.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
    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. name Victoza
    D. 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.3.4Pharmaceutical 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 INNLIRAGLUTIDE
    D.3.9.1CAS number 204656-20-2
    D.3.9.4EV Substance CodeSUB25238
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    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 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 superiority of liraglutide at the maximum tolerated dose (0.6 mg, 1.2 mg, 1.8 mg) in combination with metformin in controlling glycaemia versus metformin and liraglutide placebo in children and adolescent (ages 10?17 years) with type 2 diabetes.
    Confirmar la superioridad de la liraglutida en la dosis máxima tolerada (0,6 mg, 1,2 mg, 1,8 mg) en combinación con metformina para controlar la glucemia en comparación con metformina y placebo de liraglutida en niños y adolescentes (edad 10?17 años) con diabetes de tipo 2.
    E.2.2Secondary objectives of the trial
    To assess and compare the effect of liraglutide in combination with metformin versus metformin alone on:
    - Parameters of glycaemic control
    - Safety and tolerability
    Evaluar y comparar el efecto de la liraglutida en combinación con metformina en comparación con metformina sola en:
    ?Parámetros de control de la glucemia
    ?Seguridad y tolerabilidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Children and adolescents between the ages of 10?17 years. Subjects cannot turn 18 before completion of the 14 week double blind period (Visit 11)
    - Diagnosis of type 2 diabetes mellitus and treated for at least 90 days with diet and exercise alone, or diet and exercise in combination with metformin monotherapy. The metformin dose must be stable for at least 30 days prior to screening (Visit 1).
    - HbA1c
    - ?7.0% and ?11% if diet and exercise treated
    - ?6.5% and ?11% if treated with metformin
    - Body mass index (BMI) >85% percentile of the general age and gender matched population
    ? Niños y adolescentes de 10 a 17 años de edad. Los sujetos no pueden cumplir 18 años antes de que finalice el período doble ciego de 14 semanas (visita 11).
    ? Diagnóstico de diabetes mellitus de tipo 2 y tratamiento durante al menos 90 días con dieta y ejercicio únicamente, o dieta y ejercicio en combinación con metformina en monoterapia. La dosis de metformina debe haberse mantenido estable durante al menos 30 días antes de la visita de selección (visita 1).
    ? HbA1c
    ? Mayor o igual a 7,0 % y menor o igual a 11 % si el tratamiento consiste en dieta y ejercicio.
    ? Mayor o igual a 6,5 % y menor o igual a 11 % si el sujeto está recibiendo metformina.
    ? Índice de masa corporal (IMC) superior al percentil 85 de la población general de la misma edad y sexo.
    E.4Principal exclusion criteria
    - Type 1 diabetes
    - Maturity onset diabetes of the young (MODY)
    - Use of any antidiabetic agent other than metformin within 90 days prior to screening. Short term treatment with insulin is allowed
    - Recurrent severe or major hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
    - History of chronic pancreatitis or idiopathic acute pancreatitis
    - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator?s opinion could interfere with results of the trial
    - Uncontrolled hypertension, treated or untreated >99th percentile for age and gender in children
    - Known or suspected abuse of alcohol or narcotics
    ? Diabetes de tipo 1.
    ? Diabetes juvenil de comienzo en la madurez (MODY).
    ? Utilización de antidiabéticos distintos de metformina en los 90 días previos a la visita de selección. Se permite el tratamiento a corto plazo con insulina.
    ? Hipoglucemia intensa o importante recurrente o falta de conciencia de la hipoglucemia según el criterio del investigador.
    ? Antecedentes de pancreatitis crónica o pancreatitis aguda idiopática.
    ? Cualquier trastorno con importancia clínica, salvo los procesos asociados a los antecedentes de diabetes de tipo 2 que, en opinión del investigador, pudiera interferir en los resultados del ensayo.
    ? Hipertensión no controlada, tratado o no tratada, por encima del percentil 99 para la edad y el sexo en niños.
    ? Abuso confirmado o sospechado de alcohol o narcóticos.
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c
    Cambio en HbA1c
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 14
    Desde el momento basal hasta la semana 14
    E.5.2Secondary end point(s)
    1. HbA1c <7.0% (yes/no)
    2. HbA1c ?6.5% (yes/no)
    3. HbA1c <7.0% without severe or minor hypoglycaemic episodes (yes/no)

    Change from baseline:
    4. Fasting plasma glucose (FPG)
    5. 7-point self-measured plasma glucose

    6. Adverse events (AEs) and serious adverse events (SAEs)
    7. Safety follow-up after 1 and 2 years: AEs and SAEs, growth velocity and pubertal progression
    1. HbA1c < 7,0 % (sí/no)
    2. HbA1c ? 6,5 % (sí/no)
    3. HbA1c < 7,0 % sin episodios de hipoglucemia intensa o leve (sí/no)

    Variación desde el momento basal:
    4. Glucosa plasmática en ayunas (GPA)
    5. Glucosa plasmática medida por el propio paciente en 7 puntos temporales

    6. Acontecimientos adversos (AA) y acontecimientos adversos graves (AAG)
    7. Seguimiento de la seguridad después de 1 y 2 años: AA y AAG, velocidad de crecimiento y progresión de la pubertad
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints 1-5: At 14, 26 and 52 weeks of treatment
    Endpoints 6-7: After 53 weeks, and after 1 and 2 years after LPLV
    Criterios de valoración 1-5: a 14, 26 y 52 semanas de tratamiento
    Criterios de valoración 6-7: tras 53 semanas y tras 1 año y 2 años después de la última visita del último paciente
    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. 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. trial design description
    Seguido de una externsión abierta de 38 semanas
    Followed by 38-week open-label extension
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Czech Republic
    Macedonia, the former Yugoslav Republic of
    Russian Federation
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Última visita del último paciente (UVUP)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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 Yes
    F.1.1Number of subjects for this age range: 172
    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) Yes
    F. of subjects for this age range: 12
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 160
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 172
    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)
    No aplica
    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 Decision2012-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
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