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    Summary
    EudraCT Number:2013-000418-39
    Sponsor's Protocol Code Number:EPREDICE2013
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-10-08
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-000418-39
    A.3Full title of the trial
    Early Prevention of Diabetes Complications in people with Hyperglycaemia in Europe
    Prevención temprana de complicaciones por diabetes en personas con hiperglucemia en Europa
    Wczesne zapobieganie powikłaniom cukrzycy u osób z hiperglikemią w Europie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Early Prevention of Diabetes Complications in people with Pre-Diabetes in Europe
    Prevención temprana de complicaciones por diabetes en personas con pre-diabetes en Europa
    Wczesne zapobieganie powikłaniom cukrzycy u osób z tzw. stanem przedcukrzycowym w Europie
    A.3.2Name or abbreviated title of the trial where available
    e-PREDICE
    A.4.1Sponsor's protocol code numberEPREDICE2013
    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 SponsorEVIDEM CONSULTORES SL (EVIDEM)
    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 supportEuropean Commission FP7
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr Aleksandra-Gilis Januszewska
    B.5.2Functional name of contact pointKatedra i Klinika Endokrynologii UJ
    B.5.3 Address:
    B.5.3.1Street AddressKopernika 17
    B.5.3.2Town/ cityKraków
    B.5.3.3Post code31-501
    B.5.3.4CountryPoland
    B.5.5Fax number12 424-73-99
    B.5.6E-mailmyjanusz@cyfr-kr.edu.pl
    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 Gluocophage 850 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sante s.a.s.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameGLUCOPHAGE/GLUCOPHAGE FORTE/DIANBEN/RISIDON 850mg film-coated tablet
    D.3.4Pharmaceutical form Film-coated 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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.1CAS number 657-24-9
    D.3.9.3Other descriptive nameMETFORMIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    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.IMP: 2
    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 Trajenta 5 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Film-coated 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 INNLinagliptin
    D.3.9.1CAS number 668270-12-0
    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 number5
    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.IMP: 3
    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 Jentadueto 2.5 mg/850 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Film-coated 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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.1CAS number 657-24-9
    D.3.9.3Other descriptive nameMETFORMIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLinagliptin
    D.3.9.1CAS number 668270-12-0
    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 number2.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non diabetic hyperglycaemia:
    Impaired Glucose Tolerance (IGT) or Impaired Fasting Glucose (IFG) or both
    Hiperglucemia No Diabética:
    Intolerancia la Glucosa (ITG), Glucosa en ayuno alterada (GAA) o ambas
    E.1.1.1Medical condition in easily understood language
    Pre- diabetes
    Pre-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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10065542
    E.1.2Term Prediabetes
    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 assess the effect of treatment with linagliptin, metformin or the combination of linagliptin with metformin, plus lifestyle intervention (diet and physical activity), compared to lifestyle intervention alone, for at least 2 years, and up to 4 years, on different microvascular parameters (retinal, renal and neurological), as defined by the primary and secondary endpoints, in adults with non diabetic hyperglycaemia (IGT, IFG or IFG plus IGT).
    Evaluar el efecto del tratamiento combinado de linagliptina, la metformina o la combinación de linagliptina con metformina, y modificación de estilos de vida (dieta y actividad física), en comparación con la intervención de estilo de vida únicamente, por lo menos durante 2 años y hasta 4 años, sobre diferentes parámetros microvasculares (retina, renal y neurológica, en adultos con hiperglucemia no diabéticos (IGT, IFG o IGT más IFG).
    E.2.2Secondary objectives of the trial
    1- To identify among people with hyperglycaemia who are most likely to develop early diabetic complication
    2- To determine the extent to which the compliance to the interventions affect the rate on early diabetic complications prevention
    3- To evaluate the effect of the different treatment regimes applied in this study on quality of life and neuropsychological functions
    4- To assess the efficacy of treatment with linagliptin, metformin and the combination of sitagliptin with metformin plus lifestyle intervention in comparison to lifestyle intervention alone with regard to surrogate parameters of vascular function and structure, and novel biomarkers of microvascular damage in adults with hyperglycaemia (IGT, IFG or IFG plus IGT)
    5- To determine the safety of linagliptin or metformin and the combination of sitagliptin with metformin plus lifestyle intervention in people with non diabetic hyperglycaemia with regard to severe adverse effects and clinically important events
    1 - Identificar las personas con hiperglucemia que tienen más probabilidades de desarrollar complicaciones tempranas de la diabetes
    2 – Evaluar si el grado de cumplimiento de las intervenciones afectan a la tasa en la prevención de complicaciones tempranas de la diabetes
    3 - Evaluar el efecto de los diferentes regímenes de tratamiento aplicados en este estudio sobre la calidad de vida y las funciones neuropsicológicas
    4 - Evaluar la eficacia del tratamiento con linagliptina, metformina y la combinación más una intervención estilo de vida en comparación con la intervención de estilo de vida con respecto a los parámetros de la función y estructura vascular, y nuevos biomarcadores de daño microvascular en adultos con hiperglucemia (IGT, IFG o IGT más IFG)
    6 - Determinar la seguridad de linagliptina o metformina y la combinación más una intervención estilo de vida en personas con hiperglucemia diabética en cuanto a efectos adversos graves y los eventos clínicamente importantes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women
    • Age 45 -74 years
    • Impaired Fasting Glucose (IFG): FPG 6.1 to 6.9mmol/l and 2-h PG <7.8mmol/L; or Impaired Glucose Tolerance (IGT): FPG <7.0mmol/L and 2h PG >_7.8 and <11.1 mmol/L; or both conditions;
    • Informed consent given
    • Hombres y mujeres
    • Edad 45 -74 años
    • Glucosa alterada en ayunas (GAA): Glucosa Plasmática en ayuno: 6,1 a 6,9 mmol / l y Glucosa a 2 h-Post carga: <7,8 mmol / L., o intolerancia a la glucosa (IGT): Glucosa Plasmática en ayuno <7,0 mmol / L y Glucosa a 2 h-Post carga > _7.8 y 11,1 <mmol / L, o ambas condiciones;
    • El consentimiento informado firmado
    E.4Principal exclusion criteria
    • Type 1 diabetes.
    • Known* or unknown T2D (including screen detected T2D) with or without pharmacological treatment.
    • Use of a GLP-1 receptor agonist (exenatide or other) or pramlintide or any dipeptidyl peptidase 4 (DPP-4) inhibitor or metformin within the 3 months prior to enrolment.
    • Use of insulin or long-acting insulin analogue within 3 months prior to enrolment.
    • Any previous cardiovascular or cerebrovascular clinically documented event or revascularization procedure*.
    • Clinical evidence of macro-vascular complications (overt clinical cardiovascular disease) at enrolment, including angina (stable or unstable) and evidence of previous myocardial infarction in baseline EKG.
    • Current renal replacement therapy.
    • A previous diagnosis of liver cirrhosis or chronic hepatitis*, or an elevation of liver enzymes (AST and or ALT) >3 tiems normal ranges.
    • Previous diagnosis of Chronic heart failure (NYHA class III or higher).
    • A prior solid organ transplant or awaiting solid organ transplant.
    • 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.
    • Any acute condition or exacerbation of chronic condition that would in the Investigator's opinion interfere with the initial trial visit schedule and procedures.
    • Known or suspected hypersensitivity to trial products or related products.
    • Known use of non prescribed narcotics or illicit drugs.
    • Simultaneous participation in any other clinical trial of an investigational agent.
    • Females of childbearing potential who are pregnant (all fertile women will be tested for before randomization), breast-feeding or intend to become pregnant.
    • Presence of cataract that impedes the retinal evaluation of both eyes.
    • Other previously diagnosed retinal diseases.
    • Any diseases that would prevent the measurement of primary endpoints
    • Dementia, mental disorder or evident cognitive impairment unable to give informed consent.
    • End-stage or metastatic cancer.
    • Institutionalization.
    • Renal function impairment: GFR <60 ml/min/1.73m2.
    • Contraindication to any of the study drugs (metformin or linagliptin). This includes: ALT > 3 times the upper limit of normal, history of cirrhosis or hepatitis, suspected renal artery stenosis, recent gastrointestinal bleeding (within the last year), pregnant, breastfeeding or a female of child-bearing potential not on reliable contraception and also any circumstance where ongoing medication might lead to potential adverse drug interaction with components of the trial medications.
    • Any other reason, medical condition, ongoing medication or significant disability that would prevent the participant complying with trial consent, treatment and follow-up procedures or potentially jeopardise her/his medical care.
    * Previous diagnosis should be documented after medical record review.
    - Diabetes tipo 1 (DT1).

    - Diabetes Tipo 2 (DT2) conocida* o desconocida (incluyendo la detección por cribado de DT2) con o sin tratamiento farmacológico.

    - Uso de un agonista receptor GLP-1 (exenatida u otro) o pramlintida o cualquier inhibidor dipeptitl peptidasa 4 (DPP-4) o metformina en los tres meses previos al ingreso en el estudio.

    - Uso de insulina o un análogo de insulina de acción prolongada en los tres meses previos al ingreso en el estudio.

    - Cualquier evento previo cardiovascular o cerebrovascular clínicamente documentado o procedimiento de revascularización*.

    - Evidencia clínica de complicaciones macrovasculares (enfermedad cardiovascular clínicamente manifiesta) en el ingreso al estudio, incluyendo angina (estable o inestable) y evidencia de infarto de miocardio previo en el electrocardiograma inicial.

    - Tratamiento Actual de reemplazo renal.

    - Diagnóstico previo de cirrosis hepática o hepatitis crónica, o un aumento de enzimas hepáticas (AST y/o ALT) mayor a tres veces el rango normal.

    - Diagnóstico previo de Insuficiencia cardiaca previo (clase NYHA III o mayor).

    - Transplante previo de un órgano sólido o a la espera de transplante de órgano sólido.

    - Neoplasia maligna que requiere quimioterapia, cirugía, radiación o terapia paliativa en los 5 años previos. Se permite el ensayo en sujetos con carcinoma de células escamosas intrapitelial de piel (enfermedad de Bowen) tratados con 5-fluoriuracil (5FU) de uso tópico y sujetos con cáncer basocelular de piel.

    - Cualquier condición aguda o exacerbación de una condición crónica que en la opinión de investigador interfiriese con la planificación inicial de las visitas del ensayo y los procedimientos.

    - Conocimiento o sospecha de hipersensibilidad a productos del ensayo o productos relacionados.

    - Uso conocido de narcótico sin prescripción o drogas ilícitas.

    - Participación simultánea en algún otro ensayo clínico de una agencia de investigación

    - Mujeres con posibilidad de estar embarazadas que estén embarazadas (todas las mujeres fértiles serán testadas antes del reclutamiento), en fase de lactancia o con intención de quedarse embarazadas.

    - Presencia de cataratas que impida la evaluación de retina de ambos ojos.

    - Otros diagnósticos previos de enfermedades de la retina.

    - Cualquier enfermedad que pudiese intervenir en las evaluaciones de los objetivos primarios.

    - Demencia, desorden mental o deterioro cognitivo evidente que incapacite proporcionar el consentimiento informado.

    - Estadio terminal de cáncer o metástasis.

    - Institucionalización.

    - Insuficiencia renal: GFR< 60ml/min/1.73m2.

    - Contra indicación a algún medicamento del estudio (metformina o linagliptina). Esto incluye: ALT mayor a tres veces el límite superior normal, historial de cirrosis o hepatitis, sospecha de estenosis de arteria renal, sangrado gastrointestinal reciente (durante el último año), embarazo, lactancia o mujer con posibilidad de concepción sin contracepción segura y también cualquier circunstancia que la medicación en curso pueda provocar interacciones adversas entre los componentes de la medicación del ensayo.

    - Cualquier otra razón, condición médica, medicación en curso o discapacidad significativa que pueda impedir el cumplimiento del consentimiento del ensayo, el tratamiento y los procedimientos de seguimiento o que pongan potencialmente en peligro su atención médica.

    * Diagnóstico previo que debe ser documentado tras la revisión del historial clínico.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is a combined continuous variable, "the microvascular complication índex" (MCI), composed by the linear combination of the Early Treatment Diabetic Retinopathy Study Scale (ETDRS) score, the level of urinary albumin to creatinine ratio, and sudomotor test (SUDOSCAN) score, measured during the 24th and 36th month visits.
    La evaluación primaria es una variable continua combinada: "el índice de complicaciones microvasculares (MCI, según sus siglas en inglés) compuesto por la combinación lineal de la Escala del Estudio del Tratamiento Temprano de Retinopatía Diabética (ETDRS, según sus siglas en inglés), el cociente entre el nivel de albúmina y creatinina urinaria, y el resultado del test sudomotor (SUDOSCAN), medido durante las visitas de los meses 24 y 36.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 and 36months after randomization
    Meses 24 y 36 tras la randomización.
    E.5.2Secondary end point(s)
    • Retinopathy score at last visit defined as 2 steps progression on the ETDRS scale between baseline and visits at months 24th and 36h .
    • One standard deviation (SD) increase on the level of urinary albumin to creatinine ratio between baseline and visits at months 24th and 36h .
    • One SD decrease Changes in the level of hands and feet conductance in SUDOSCAN between baseline and visits at months 24th and 36h .

    • Change in microvascular endothelial function (MEF) measured by the EndoPAT method (in a subset).
    • Change in the Non-Alcoholic Fatty Liver (NAFL) Index (in a subset).
    • Change in biomarkers of microvascular damage, endothelial function, per-oxidation, inflammation, and metabolomics (in a subset).
    • Change in the insulin secretion and β-cell function.
    • Change in self-perceived Quality of Life (QoL).
    • Change in symptoms of peripheral neuropathy
    • Change in neuropsychological parameters: cognitive function, anxiety and depressive symptoms and indices.
    • Changes in Obstructive Sleep Apnoea (OSA) indices as measured by Somnomedics (in a subset).
    • Changes in ambulatory blood pressure monitoring (in a subset)
    • Change in the mean common carotid intimae-media thickness (CIMT) (in a subset).
    • Incidence of major cardiovascular events, defined as an expanded composite of total coronary events, total stroke events, revascularization procedures (coronary artery bypass graft, percutaneous coronary angioplasty, and peripheral revascularization), hospitalization for heart failure, transient ischaemic attack, and cardiovascular or cerebrovascular death
    - Resultado de la retinopatía de la última visita definida como dos pasos de progresión en la escala ETDRS entre la primera visita y las visitas de los meses 24 y 36.

    - Aumento de la desviación estándar (SD, según sus siglas en inglés) en el cociente entre el nivel de albúmina y creatinina urinaria entre la primera visita y las visitas de los meses 24 y 36.

    - Decrecimiento de los cambios de SD en los niveles de conductancia de manos y pies medidos en SUDOSCAN entre la primera visita y las visitas de los meses 24 y 36.

    - Cambio en la función endotelial microvascular (MEF, según sus siglas en inglés) medido mediante el método EndoPAT (en una submuestra).

    - Cambio en el índice del Hígado Graso No Alcohólico (NAFL, según sus siglas en inglés). (en una submuestra).

    - Cambio en los biomarcadores de daño microvascular, función endotelial, peroxidación, inflamación, y metabolómica (en una submuestra).

    - Cambio en la secreción de insulina y la función de las células beta.

    - Cambio en la auto percepción de la Calidad de Vida (QoL, según sus siglas en inglés).

    - Cambio en los síntomas de la neuropatía periférica.

    - Cambio en los parámetros neuropsicológicos: índices de función cognitiva, ansiedad y síntomas depresivos.

    - Cambios en los índices de Apnea Obstructiva del Sueño (OSA, según sus siglas en inglés) medidos mediante Somnomedics (en una submuestra).

    - Cambios en la monitorización de la presión sanguínea ambulatoria (en una submuestra).

    - Cambio en el grosor íntima-media carotideo (CIMT, según sus siglas en inglés) común (en una submuestra).

    - Incidencia de eventos cardiovasculares importantes, definidos como un variable compuesta de eventos coronarios totales, eventos de apoplejía totales, procedimientos de revascularización (injerto de derivación de arteria coronaria, angioplastia percutánea coronaria, y revascularización periférica), hospitalización por insuficiencia cardíaca, ataque isquémico transitorio, y cardiovascular o muerte cerebral.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 and 36 months.
    Meses 24 y 36
    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 No
    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.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 No
    E.8.1.3Single blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Intervencion en estilos de vida
    lifestyle intervention
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Austria
    Bulgaria
    Greece
    Italy
    Lithuania
    Poland
    Serbia
    Spain
    Turkey
    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
    Last Visit Last Object (LVLS)
    Última visita del último sujeto de estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 1500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1400
    F.4.2.2In the whole clinical trial 2000
    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 Decision2015-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-26
    P. End of Trial
    P.End of Trial StatusOngoing
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