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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43925   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
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    EudraCT Number:2009-012201-19
    Sponsor's Protocol Code Number:EX2211-3748
    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:2010-07-21
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2009-012201-19
    A.3Full title of the trial
    (ES): Efecto y acción de laliraglutida en la diabetes: evaluación de los resultados de criterios de valoración cardiovasculares. Estudio a largo plazo, multicéntrico, internacional, aleatorizado, doble ciego y controlado con placebo para determinar los efectos de la liraglutida sobre los episodios cardiovasculares.
    (EN): Liraglutide Effect and Action in Diabetes:
    Evaluation of cardiovascular outcome Results
    A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberEX2211-3748
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    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 support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 6 mg/ml solución inyectable en pluma precargada
    D. 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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    (ES): Diabetes mellitus tipo 2
    (EN): Type 2 diabetes mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    (ES): Evaluar el efecto del tratamiento con liraglutida en comparación con un placebo durante un mínimo de 3,5 años y un máximo de 5 años sobre la incidencia de episodios cardiovasculares, según lo definido por los siguientes criterios de valoración principales y secundarios, en adultos con diabetes tipo 2 que tienen un riesgo elevado de sufrir episodios cardiovasculares.
    (EN): To assess the effect of treatment with liraglutide compared to placebo for at least 3.5 year and up to 5 years on the incidence of cardiovascular events, as defined by the below primary and secondary endpoints, in adults with type 2 diabetes that are at high risk for cardiovascular events
    E.2.2Secondary objectives of the trial
    (ES): Evaluar la eficacia y la seguridad con respecto a acontecimientos clínicamente importantes u otros parámetros sustitutivos del tratamiento con liraglutida en comparación con un placebo en adultos con diabetes tipo 2 que tienen un riesgo elevado de sufrir episodios cardiovasculares.
    (EN): To assess the efficacy and safety with regard to clinically important events or other surrogate parameters of treatment with liraglutide compared to placebo in adults with type 2 diabetes that are at high risk for cardiovascular events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Varones o mujeres con diabetes de tipo 2.
    • Edad mayor o igual a 50 años en el momento de la selección y enfermedad cardiovascular, enfermedad cerebrovascular, vasculopatía periférica, insuficiencia renal crónica o insuficiencia cardiaca crónica o edad mayor o igual a 60 años en el momento de la selección y otros factores de riesgo especificados de vasculopatía.
    • HbA1c mayor o igual a 7,0% en el momento de la selección.
    - Men or women with type 2 diabetes
    - Age major or equal to 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age major o equal to 60 years at screening and other specified risk factors of vascular disease
    - HbA1c major or equal to 7.0% at screening
    E.4Principal exclusion criteria
    • Diabetes tipo 1.
    • Uso de un agonista de los receptores del GLP-1 (exenatida, liraglutida u otro) o pramlintida o cualquier inhibidor de la dipeptidil-peptidasa 4 (DPP-4) en los 3 meses previos a la selección.
    • Uso de insulina distinta de la insulina de tipo protamina neutra de Hagedorn (NPH) humana o de un análogo de la insulina de acción prolongada en los 3 meses previos a la selección. Se permite, a discreción del investigador, el uso a corto plazo durante ese periodo de otro tipo de insulina por una enfermedad intercurrente.
    • Descompensación aguda del control de la glucemia que requiere una intensificación inmediata del tratamiento para prevenir complicaciones agudas de la diabetes (por ejemplo, cetoacidosis diabética) en los 3 meses previos.
    • Episodio coronario o cerebrovascular agudo en los 14 días previos.
    • Terapia de reemplazo renal continuo
    • Hepatopatía terminal.
    • Insuficiencia cardiaca en clase funcional IV de la NYHA.
    • Trasplante de órgano sólido previo o a la espera de un trasplante de órgano sólido.
    • Familia o antecedentes personales de neoplasia endocrina múltiple de tipo 2 (MEN2) o carcinoma medular de tiroides familiar (CMTF).
    • Antecedentes personales de carcinoma medular de tiroides no familiar.
    • Neoplasia maligna que requería quimioterapia, cirugía, radioterapia o tratamiento paliativo en los 5 años anteriores. Se permitirá participar en el estudio a sujetos con carcinoma epidermoide intraepitelial de la piel (enfermedad de Bowen) tratados con 5-fluorouracilo (5FU) tópico y a sujetos con cáncer de piel basocelular.
    - Type 1 diabetes
    - Use of a GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any (dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening
    - Use of insulin other than human neutral protamine hagedorn (NPH) insulin or long-acting insulin analogue within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed at Investigator's discretion
    - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (e.g., diabetic ketoacidosis) in the previous 3 months
    - An acute coronary or cerebrovascular event in the previous 14 days
    - Current continuous renal replacement therapy
    - End-stage liver disease
    - Chronic heart failure NYHA IV
    - A prior solid organ transplant or awaiting solid organ transplant
    - Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial
    medullary thyroid carcinoma (FMTC)
    - Personal history of non-familial medullary thyroid carcinoma
    - Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Subjects with intraepithelial squamous cell carcinoma of the skin (Bowen's disease) treated with topical 5-fluorouracil (5FU) and subjects with basal cell skin cancer are allowed to enter the trial
    E.5 End points
    E.5.1Primary end point(s)
    (ES): Tiempo desde la aleatorización hasta la primera aparición de muerte de origen cardiovascular, infarto de miocardio no mortal o ictus no mortal (un criterio de valoración cardiovascular compuesto).
    (EN): Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome)
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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
    Run-in period is open label
    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.8.3 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 EEA133
    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
    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
    Not applicable
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days19
    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.1.3Elderly (>=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 2010-07-21. 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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3000
    F.4.2.2In the whole clinical trial 8754
    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)
    Not applicable
    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 Decision2010-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
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