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    Summary
    EudraCT Number:2018-000650-21
    Sponsor's Protocol Code Number:PHARMADIPOAGE
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-14
    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 number2018-000650-21
    A.3Full title of the trial
    CLINICAL TRIAL FOR EVALUATION OF THE ADIPOQUINAS: NEW PHARMACOLOGICAL TARGETS TO PREVENT VASCULAR AGING
    ENSAYO CLÍNICO PARA EVALUACIÓN DE LAS ADIPOQUINAS: NUEVAS DIANAS FARMACOLÓGICAS PARA PREVENIR EL ENVEJECIMIENTO VASCULAR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate biomarkers of vascular aging
    Ensayo clínico para evaluar biomarcadores de envejecimiento vascular
    A.4.1Sponsor's protocol code numberPHARMADIPOAGE
    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 SponsorUniversidad Autónoma de Madrid
    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 supportMINISTERIO DE ECONOMÍA INDUSTRIA Y COMPETITIVIDAD
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL UNIVERSITARIO LA PAZ
    B.5.2Functional name of contact pointELENA BERMEJO-UCICEC
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 261
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number3491207 14 66
    B.5.5Fax number3491207 14 66
    B.5.6E-mailebermejo.ucicec@gmail.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 Yes
    D.2.1.1.1Trade name Dianben 850 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Santé s.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.3.1Product nameMETFORMINA
    D.3.4Pharmaceutical form Compressed lozenge
    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
    D.3.9.1CAS number 657-24-9
    D.3.9.4EV Substance CodeSUB08831MIG
    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
    PREDIABETES
    PREDIABETES
    E.1.1.1Medical condition in easily understood language
    PREDIABETES
    PREDIABETES
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    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 identify biomarkers of endothelial dysfunction in prediabetic patients and their evolution over time depending on whether they are receiving pharmacological treatment or not. Specifically, we will evaluate IL1-β, visfatin / Nampt, sDPP4 and klotho as plasma biomarkers.
    Identificar biomarcadores de disfunción endotelial en pacientes prediabéticos y su evolución en el tiempo según esté recibiendo tratamiento farmacológico o no. Específicamente valoraremos IL1-β, visfatina/Nampt, sDPP4 y klotho como biomarcadores plasmáticos.
    E.2.2Secondary objectives of the trial
    1. Evaluate the evolution of hyperglycemia (basal glycemia, glycosylated hemoglobin, oral glucose tolerance curve).

    2.Determine changes in the parameters of cardiovascular (weight, BMI) and analytical (glycemia, HbA1c and lipid profile) and their correlation with the plasma levels of the different biomarkers.

    3. Determine the rate of adverse events.

    4.Determine the correlation between levels of plasma biomarkers and the levels of inflammation and senescence in mononuclear cells of patients.

    5. Analyze the direct effect of IL1-β, visfatin / Nampt, sDPP4 and klotho on mononuclear cells isolated from a control group of healthy volunteers.
    1.Evaluar la evolución de la hiperglicemia (glucemia basal, hemoglobina glicosilada, curva tolerancia oral a glucosa).

    2.Determinar cambios en los parámetros de riesgo cardiovascular (peso, IMC) y analítica (glucemia, HbA1c y perfil lipídico) y su correlación con los niveles plasmáticos de los distintos biomarcadores.

    3.Determinar la tasa de acontecimientos adversos.

    4.Determinar la correlación entre los niveles de biomarcadores plasmáticos y los niveles de inflamación y senescencia en células mononucleares de los pacientes.

    5.Analizar el efecto directo de IL1-β, visfatina/Nampt, sDPP4 y klotho sobre células mononucleares aisladas de un grupo control de voluntarios sanos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age between 18 and 60 years
    2. That meets at least one of the following prediabetes criteria:
    a.Basal glucose between 100 and 125 mg / dl repeated twice, or
    b.Glycemia between 140 and 199 mg / dl at two hours of the oral glucose tolerance test of 75 grams,
    c. Glycosylated hemoglobin (HbA1c) between 5.7 and 6.4%
    3. Obesity grade II or higher (BMI ≥ 35 kg / m2).
    4. Patient agrees to participate in the study by signing informed consent.
    1. Edad entre 18 y 60 años
    2. Que cumpla al menos uno de los siguientes criterios de prediabetes:
    a. Glucemia basal entre 100 y 125 mg/dl repetida en dos ocasiones, o
    b. Glucemia entre 140 y 199 mg/dl a las dos horas del test de tolerancia oral a la glucosa de 75 gramos,
    c. Hemoglobina glicosilada (HbA1c) entre 5,7 y 6,4%
    3. Obesidad grado II o superior (IMC ≥ 35 kg/m2).
    4. Que acepte participar en el estudio firmando el consentimiento informado.
    E.4Principal exclusion criteria
    1. Patients who are receiving some hypoglycemic treatment
    2. Patients with severe hepatic or renal insufficiency; NYHA grade III or IV heart failure or neoplastic processes, except basal cell carcinoma .
    3. Patients who for any reason should not be included in the study according to the evaluation of the research team.
    4. Pregnant women
    1.Pacientes que estén recibiendo algún tratamiento hipoglucemiante
    2.Pacientes con insuficiencia hepática o renal grave; insuficiencia cardíaca grado III o IV de NYHA o procesos neoplásicos, exceptuando basalioma cutáneo.
    3.Pacientes que por cualquier motivo no deberían ser incluidos en el estudio según evaluación del equipo investigador.
    4.Mujeres embarazadas.
    E.5 End points
    E.5.1Primary end point(s)
    Validate visfatin / Nampt, sDPP4, IL6 (as an indirect marker of IL-1β) and klotho as biomarkers of endothelial dysfunction in prediabetic patients and their evolution over time as they are receiving pharmacological treatment or not.
    Validar visfatina/Nampt, sDPP4, IL6 (como marcador indirecto de IL-1β) y klotho como biomarcadores de disfunción endotelial en pacientes prediabéticos y su evolución en el tiempo según estén recibiendo tratamiento farmacológico o no.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 0, 12 y 24
    Mes 0, 12 y 24
    E.5.2Secondary end point(s)
    • Evolution of prediabetes parameters (basal glycaemia, glycosylated hemoglobin, oral glucose tolerance curve).

    • Changes in the cardiovascular risk assessment variables and their correlation with the plasma levels of the different biomarkers to be evaluated:
    - Weight, BMI, waist circumference, blood pressure
    - Analytics: Glycemia, HbA1c, insulinemia, lipid profile, HOMA-IR index
    - Glucose during oral glucose tolerance curve
    •Evolución de los parámetros de prediabetes (glucemia basal, hemoglobina glicosilada, curva tolerancia oral a glucosa).

    •Cambios en las variables de evaluación de riesgo cardiovascular y su correlación con los niveles plasmáticos de los distintos biomarcadores a evaluar:
    - Peso, IMC,circunferencia de la cintura, Tensión Arterial
    - Analítica: Glucemia, HbA1c, insulinemia, perfil lipídico,índice HOMA-IR
    - Glucemia durante curva de tolerancia oral a glucosa
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 0, 12 y 24
    Mes 0, 12 y 24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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.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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Cambios en hábitos de vida: actividad física y dieta
    Changes in life habits: physical activity and diet
    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 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
    LVLS
    Ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months42
    E.8.9.1In the Member State concerned days
    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) 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 state150
    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 Decision2018-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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