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    Summary
    EudraCT Number:2017-005136-41
    Sponsor's Protocol Code Number:FIM-DAPA-2018-01
    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:2018-10-25
    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 number2017-005136-41
    A.3Full title of the trial
    SGLT-2 Inhibition and Cardiovascular Disease. Metabolomics Study of Potential Factors Involved in Cardioprotection
    Inhibición de SGLT-2 y Enfermedad Cardiovascular. Estudio Metabolómico de Potenciales Factores Involucrados en la Cardioprotección
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SGLT-2 Inhibition, Metabolomics and Cardiovascular Disease
    Inhibición de SGLT-2, Metabolómica y Enfermedad Cardiovascular
    A.4.1Sponsor's protocol code numberFIM-DAPA-2018-01
    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 SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina Y Salud (FIMABIS)
    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 supportAstraZeneca
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIMABIS
    B.5.2Functional name of contact pointPlataforma de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressHospital Regional Universitario, Avda. Carlos Haya s/n
    B.5.3.2Town/ cityMálaga
    B.5.3.3Post code29010
    B.5.3.4CountrySpain
    B.5.6E-mailestudios.clinicos@fimabis.org
    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 Forxiga 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 INNDapaglifozin
    D.3.9.1CAS number 461432-26-8
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB31650
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboTablet
    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
    Type 2 Diabetes mellitus
    Diabetes mellitus tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes (adult diabetes)
    Diabetes tipo 2 (diabetes del adulto)
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    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 evaluate the metabolomics changes associated with dapagliflozin or placebo after 12 weeks of treatment, both in plasma and urine
    Evaluar los cambios metabolómicos en sangre y orina, relacionados con el uso de Dapaglifozina o Placebo tras 12 semanas de tratamiento
    E.2.2Secondary objectives of the trial
    - Changes in body mass index (BMI) after 12 weeks of treatment with dapagliflozin or placebo.
    - Changes in insulin resistance (measured by HOMA-IR) after 12 weeks of treatment with dapagliflozin or placebo.
    - Changes in HbA1c after 12 weeks of treatment with dapagliflozin or placebo.
    - Changes in the SF-36 questionnaire (quality of life) after 12 weeks of treatment with dapagliflozin or placebo.
    - Cambios en el Índice de Masa Corporal (IMC), cambios en la resistencia insulínica (medidos mediante HOMA-IR), cambios en la HbA1c y cambios en el cuestionario de calidad de vida (SF-36) tras 12 semanas de tratamiento con dapaglifozina o placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-75.
    - BMI 27-39.9 kg/m2.
    - T2DM under treatment with metformin and inadequate metabolic control (defined as HbA1c≥6.5% and ≤7%).
    - Edad 18-75.
    - IMC 27-39.9 kg/m2.
    - DM Tipo2 en tratamiento con metformina pero con control metabólico inadecuado (definido como HbA1c≥6.5% y ≤7%).
    E.4Principal exclusion criteria
    - Pregnancy (all women of child-bearing age, unless treatment with contraceptive methods, will undergo a pregnancy test)
    - Intolerance/allergy to dapagliflozin.
    - Treatment with antidiabetic drug other than metformin.
    - Impaired kidney function: Estimated glomerular filtration rate (eGFR) (calculated using the CKD-EPI formula) <60 ml/min/1.73m2.
    - Patients with established cardiovascular disease.
    - Previous or current history of cancer of any kind.
    - Uncontrolled hypertension (systolic blood pressure≥160 mmHg or diastolic blood pressure≥110 mmHg, despite adequate antihypertensive treatment).
    - History of liver tumour or acute or chronic liver disease with impaired liver function: total bilirubin levels> 2.0 mg / dl or GOT levels three times higher than normal upper limit.
    - Known HIV infection or active HBV or HCV infection.
    - Serious underlying diseases, which could affect the patient's ability to participate in the study.
    - Reduced life expectancy (<12 months) due to the presence of advanced or terminal concomitant diseases.
    - Embarazo (todas las mujeres en edad fértil, a menos que se encuentren en tratamiento con métodos anticonceptivos, se someterá a una prueba de embarazo)
    - Intolerancia/alergia a dapagliflozina.
    - Tratamiento con medicamentos antidiabéticos que no sean metformina.
    - Función renal deteriorada: Tasa de filtración glomerular estimada (eGFR) (calculada con la fórmula CKD-EPI) <60 ml / min / 1,73 m2.
    - Pacientes con enfermedad cardiovascular establecida.
    - Historia anterior o actual de cáncer de cualquier tipo.
    - Hipertensión no controlada (presión arterial sistólica ≥160 mmHg o presión arterial diastólica ≥110 mmHg, a pesar del tratamiento antihipertensivo adecuado).
    - Historial de tumor hepático o enfermedad hepática aguda o crónica con función hepática alterada: niveles de bilirrubina total> 2,0 mg / dl o niveles GOT tres veces superiores al límite superior normal.
    - Infección conocida por VIH o infección activa por VHB o VHC.
    - Enfermedades subyacentes graves, que podrían afectar la capacidad del paciente para participar en el estudio.
    - Reducción de la esperanza de vida (<12 meses) debido a la presencia de enfermedades concomitantes avanzadas o terminales.
    E.5 End points
    E.5.1Primary end point(s)
    Metabolomics changes, both in plasma and urine.
    Cambios metabolomicos, en plasma y orina.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and after 12 weeks of treatment with dapagliflozin or placebo.
    Basal y tras 12 semanas de tratamiento con dapaglñifozina o placebo
    E.5.2Secondary end point(s)
    - BMI changes
    - Insulin resistance changes (measured as HOMA-IR)
    - Metabolic control (measured as HbA1c)
    - Quality of Life (measured as SF-36 questionnaire).
    - Cambios en IMC
    - Cambios en la resistencia a insullina (medido como HOMA-IR)
    - Control metabolico (medido como HbA1c)
    - Cambios en la calidad de vida (medido por cuestionario SF-36 ).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and after 12 weeks of treatment with dapagliflozin or placebo.
    Basal y tras 12 semanas de tratamiento con dapaglñifozina o placebo
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Metabolomics
    Metabolómica
    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 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 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 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
    LVLS
    LVLS (Última visita del último sujeto)
    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 months12
    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)
    Once subject’s participation in the study is finished, he/she will be offered the best treatment available for his/her condition.
    Una vez finalizada la participación del sujeto en el estudio, se le ofrecerá el mejor tratamiento disponible para su condición.
    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 Decision2018-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-13
    P. End of Trial
    P.End of Trial StatusOngoing
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