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    Summary
    EudraCT Number:2011-000893-68
    Sponsor's Protocol Code Number:LAED001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-07-19
    Trial 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 number2011-000893-68
    A.3Full title of the trial
    Differences in endothelial function amongst Sitagliptin and Liraglutide Users: A randomized, open-label, parallel-group and active controlled trial
    Diferencias en la función endotelial entre pacientes tratados con sitagliptina y liraglutida: ensayo clínico aleatorizado, abierto, con dos grupos en paralelo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Differences in endothelial function amongst Sitagliptin and Liraglutide Users. A randomized, open-label, parallel-group and active controlled trial
    Diferencias en la función endotelial entre pacientes tratados con sitagliptina y liraglutida: ensayo clínico aleatorizado, abierto, con dos grupos en paralelo
    A.3.2Name or abbreviated title of the trial where available
    LAED001
    LAED001
    A.4.1Sponsor's protocol code numberLAED001
    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 SponsorFundació Clinic per a la Recerca Biomèdica
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistry of Health
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trials Unit (Hospital Clínic)
    B.5.2Functional name of contact pointAnna Cruceta
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number00349322754004380
    B.5.5Fax number0034932279877
    B.5.6E-mailacruceta@clinic.ub.es
    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.2.1.1.1Trade name Liraglutide (Victoza®)
    D.2.1.1.2Name of the Marketing Authorisation holderNovoNordisk A/S, Novo Allé, DK-2880 Bagsbærd (Denmark)
    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 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.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 Yes
    D.2.1.1.1Trade name Sitagliptin (Januvia®)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp and Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU (United Kingdom)
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNS/N
    D.3.9.1CAS number 654671-77-9
    D.3.9.2Current sponsor codeS/N
    D.3.9.3Other descriptive nameSITAGLIPTIN PHOSPHATE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB25198
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 patients not well controlled at the maximum tolerated dose of metformin
    Pacientes con diabetes tipo 2 que no esten bien controlados con la dosis máxima tolerada de metformina
    E.1.1.1Medical condition in easily understood language
    type 2 diabetes patients not well controlled at the maximum tolerated dose of metformin
    Pacientes con diabetes tipo 2 que no esten bien controlados con la dosis máxima tolerada de metformina
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effects on endothelial function of a three month treatment with Liraglutide compared to Sitagliptin
    Evaluar los efectos sobre la función endotelial del tratamiento con liraglutida frente al tratamiento con sitagliptina tras tres meses de tratamiento.
    E.2.2Secondary objectives of the trial
    To assess the effects of a three month treatment with Liraglutide compared to Sitagliptin on other emerging potential cardiovascular risk factors, such as oxidative stress markers, cytokines, and soluble cell adhesion molecules.
    To compare the safety profile of both treatment groups.
    Evaluar los efectos del tratamiento con liraglutida frente al tratamiento con sitagliptina durante tres meses sobre otros posibles factores de riesgo cardiovasculares emergentes, tales como marcadores de estrés oxidativo, citoquinas y moléculas solubles de adhesión celular.
    Comparar el perfil de seguridad de ambos grupos de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
    2.Male or female patients between 45 and 65 years old
    3.Pre-existing type 2 diabetes with HbA1c between 7.0 and 9.5%
    4.Triglycerides >1.68 mmol/L
    5.HDL cholesterol <1.29 mmol/L in women and <1.04 mmol/L in men
    6.Systolic blood pressure (SBP) <130 mmHg and diastolic blood pressure (DBP) <85 mmHg or treatment with antihypertensive agents
    1. Pacientes que otorguen su consentimientoinformado
    2. Hombres y mujeres entre 45 y 65 años de edad
    3. Pacientes que presenten diabetes tipo 2 con HbA1c entre 7,0 y 9,5%
    4.Trigliceridos > 1,68 mmol / l
    5. Colesterol HDL < 1,29 mmol / L en mujeres y <1,04 mmol / L en los hombres
    6. Presión arterial sistólica (PAS) <130 mmHg y la presión arterial diastólica (PAD) <85 mmHg o en tratamiento con fármacos antihipertensivos
    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 being randomised.
    3.Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive, or males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraception
    4.Moderate or severe renal dysfunction (creatinine clearance < 60 ml/min)
    5.Previous type 2 diabetes treatment apart from metformin or insulin
    6.Current smoker or history of smoking within 6 months prior to screening.
    7.Evidence of overt cardiovascular disease, (documented coronary heart disease, class II-IV congestive heart failure, cerebrovascular disease, or peripheral vascular disease).
    8.Caffeine intake within 24 hours of endothelial function measurements.
    9.Use of any drug with known clinically significant sympathetic or parasympathetic effects, as determined by the Investigator.
    10.Initiation or change (dose or treatment regimen) in concomitant blood pressure-lowering medication within 4 weeks prior to screening and throughout the day.
    11.The receipt of any investigational medicinal product within 6 months prior to screening.
    12.Presence of cancer or other significant medical condition
    13.Inability to follow verbal or written instructions
    1. Hipersensibilidad al producto(s) o productos relacionados con el ensayo clínico
    2. Pacientes que ya hayan sido randomizados previamente en este ensayo.
    3. Mujeres en edad fértil que esten embarazadas, o en periodo de lactancia natural o que planeen quedarse embarazada o no está utilizando métodos anticonceptivos adecuados, o los hombres que son sexualmente activos y no esterilizados quirúrgicamente, que no utilicen métodos de contracepción adecuados.
    4. Insuficiencia renal moderada o grave (aclaramiento de creatinina < 60 ml / min)
    5. Que tomen otros tratamientos para la diabetes tipo 2, diferentes a metformina o insulina.
    6. Actualmente fumador o consumo de tabaco dentro de los 6 meses anteriores a la selección.
    7. Evidencia de enfermedad cardiovascular manifiesta, (enfermedad coronaria documentada,ICCV clase II-IV, enfermedad cerebrovascular o enfermedad vascular periférica).
    8. Ingesta de cafeina durante las 24 horas previas a la medición de la función endovascular.
    9. Uso de cualquier fármaco con efectos simpático o parasimpático clínicamente significativos, (a determinar por el investigador).
    10. Inicio o cambio (en la dosis o régimen de tratamiento) en la medicación de la hipertensión arterial dentro de las 4 semanas anteriores a la selección y/o en la visita basal.
    11. Que hayan recibido cualquier medicamento en investigación dentro de los 6 meses anteriores a la selección.
    12. Presencia de cáncer u otra condición médica significativa
    13. Imposibilidad de seguir las instrucciones verbales o escritas
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be comparing the baseline corrected change in endothelial function by flow-mediated vasodilation (FMD) of the brachial artery at 3 months between the treatment arms
    El objetivo principal será comparar el cambio en la función endotelial (segun datos basales) mediante la vasodilatación mediada por flujo (FMD) de la arteria braquial basal, y a los 3 meses entre los brazos del tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Twice: Baseline (To be assessed before first treatment administration) and week 12
    Dos veces: Visita Basal (Para ser evaluado antes de la primera administración del tratamiento) y en la visita de la semana 12.
    E.5.2Secondary end point(s)
    The secondary endpoints will include comparing the baseline corrected change of the following cardiovascular risk factors at 3 months between the treatment arms:
    Serum biomarkers: apolipoprotein A1, apolipoprotein B, levels of oxidized low-density lipoprotein (ox-LDL), soluble vascular cell adhesion molecule (VCAM), high sensitive C-reactive protein (hsCRP), interleukin 6 (IL-6)
    Measures of oxidative stress: nitrotyrosine, urinary free 8-iso prostaglandin F2 alpha (8-iso PGF2alpha)
    Global measure of glucose instability, particularly of postprandial hyperglycemia: 1,5-anhydroglucitol
    Lipids: Plasma total cholesterol, plasma high density lipoprotein-cholesterol (HDL-cholesterol), direct plasma low density lipoprotein-cholesterol (LDL-cholesterol), plasma triglyceride levels, free fatty acids
    Weight
    Systemic blood pressure
    Glycemic control parameters: fasting glucose, fasting insulin, haemoglobin A1c (HbA1c), 7 point glucose self monitored
    Los objetivos secundarios incluyen la comparación de los cambios de los datos basales a los tres meses de las dos ramas de tratamiento de los siguientes factores de riesgo cardiovascular:

    Biomarcadores séricos: apolipoproteína A1, apolipoproteína B,niveles de lipoproteinas oxidadas de baja densidad (ox.LDL), molécula soluble de adhesión celular vascular (VCAM), proteína C reactiva de alta sensibilidad(PCR-hs), la interleucina 6 (IL-6)
    Medidas de estrés oxidativo: nitrotirosina, ausencia de 8-iso prostaglandina en orina, F2 alfa (8-iso PGF2alpha)
    Medida global de la inestabilidad de la glucosa, especialmente de la hiperglucemia posprandial: 1,5-anhidroglucitol
    Lípidos: colesterol total, lipoproteínas de alta densidad del plasma-colesterol (HDL-colesterol), lipoproteínas del colesterol de baja densidad (LDL-colesterol) en plasma, los niveles plasmáticos de triglicéridos, ácidos grasos libres
    Peso
    Presión arterial sistémica
    Parámetros de control glucémico: glucosa en ayunas, insulina en ayunas, hemoglobina A1c (HbA1c), 7 puntos de control de la glucosa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Serum biomarkers, Measures of oxidative stress and Glycemic control parameters: Twice, Baseline (To be assessed before first treatment administration) and week 12.
    Weight, Systemic blood pressure and Lipids: 3 times, screening visit, baseline and week 12.
    Biomarcadores séricos, medidas de estrés oxidativo y parámetros de control glicémico: se evalúan dos veces, en la visita basal (antes de la primera administración del tratamiento) y en la visita de la semana 12.
    Peso, Presión sanguínea y Lípidos: Se evaluan tres veces, visita de selección, visita basal y en la visita de la semana 12.
    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 No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    Each patient will perform an individual follow-up of 3 months and so the end of the trial will be the last visit of the last subject enter.
    El seguimiento máximo de cada paciente será de tres meses, siendo el final del estudio la última visita del último pacientes incluido en el estudio.
    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 months6
    E.8.9.1In the Member State concerned days0
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state60
    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 Decision2012-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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