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    Summary
    EudraCT Number:2011-002231-26
    Sponsor's Protocol Code Number:D1693C00005
    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:2011-10-03
    Trial results View 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 number2011-002231-26
    A.3Full title of the trial
    A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study with a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg once daily in Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on a background combination of Metformin and Sulfonylurea
    Estudio fase III, de 24 semanas de duración y 28 semanas de seguimiento, multicéntrico, aleatorizado, doble ciego, controlado con placebo, para evaluar la seguridad y la eficacia de dapagliflozina 10 mg una vez al día, en pacientes con diabetes tipo 2 con un control glucémico inadecuado sobre un tratamiento de base combinado de metformina y sulfonilurea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Safety and Efficacy of Dapagliflozin in subjects with Type 2 Diabetes who have Inadequate Glycaemic Control on background combination of Metformin and Sulfonylurea
    Evaluación de la seguridad y la eficacia de dapagliflozina, en pacientes con diabetes tipo 2 con un control glucémico inadecuado sobre un tratamiento de base combinado de metformina y sulfonilurea
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberD1693C00005
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Study Information
    B.5.3 Address:
    B.5.3.1Street Addressn/a
    B.5.3.2Town/ cityn/a
    B.5.3.3Post coden/a
    B.5.3.4CountrySweden
    B.5.4Telephone number001800236993
    B.5.5Fax numbern/a
    B.5.6E-mailinformation.center@astrazeneca.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 No
    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 nameDapagliflozin
    D.3.2Product code BMS-512148
    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.3.9.1CAS number 960404-48-2
    D.3.9.2Current sponsor codeBMS-512148-05
    D.3.9.3Other descriptive nameDapagliflozin
    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 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
    Type II diabetes mellitus
    Diabetes mellitus Tipo II
    E.1.1.1Medical condition in easily understood language
    Diabetes Type II
    Diabetes Tipo II
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10012613
    E.1.2Term Diabetes mellitus non-insulin-dependent
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the change from baseline in haemoglobin A1c (HbA1c) to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.
    El objetivo principal de este ensayo es comparar el cambio en la hemoglobina A1c (HbA1c) desde el momento basal hasta la semana 24 entre dapagliflozina 10 mg en combinación con metformina y sulfonilurea frente a placebo en combinación con metformina y sulfonilurea.
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives
    · To compare the change from baseline in fasting plasma glucose (FPG) to week 24 between dapagliflozin and placebo.
    · To compare the change from baseline in total body weight to week 24 between dapagliflozin and placebo.
    · To compare the proportion of patients achieving a therapeutic glycaemic response, defined as HbA1c < 7.0%, at week 24 between dapagliflozin and placebo.
    · To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 between dapagliflozin and placebo.
    Comparar los cambios en la concentración de glucosa plasmática en ayunas (GPA)
    entre dapagliflozina y placebo desde el momento basal hasta la semana 24
    ? Comparar los cambios en el peso corporal total entre dapagliflozina y placebo desde
    el momento basal hasta la semana 24
    ? Comparar la proporción de pacientes que alcanzan una respuesta glucémica
    terapéutica, definida como una HbA1c <7,0% en la semana 24, entre dapagliflozina y placebo
    ? Comparar los cambios en la presión arterial sistólica (PAS) en sedestación entre el momento basal y la semana 8 con dapagliflozina y placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The following criteria apply to the enrolment, placebo lead-in and randomisation visits (Visits 1, 2, 3, and 4).
    1. Provision of informed consent prior to any study specific procedures.
    2. Diagnosis of type 2 diabetes mellitus.
    3. Men or women age ?18 years old, the upper age limit should be based on local metformin label restrictions.
    4. Stable dose combination therapy of metformin ³1500mg/day and at least half the maximum dose of a sulfonylurea for at least 8 weeks prior to enrolment.
    5. HbA1c inclusion criteria:
    · At enrolment (Visit 1) ? laboratory values from screening visit:
    ?7.7% and ?11.0%.
    · At the randomisation visit (Visit 4) ? laboratory values from visit 3:
    ?7.0% and ?10.5%.
    6. For women only: Women not of childbearing potential, or women of childbearing potential who comply with the following:
    - Use a highly effective method of birth control (see below) to avoid pregnancy throughout the study and for up to 4 weeks after the study.
    - Have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication and at each visit.
    Los siguientes criterios se aplican a las visitas de inclusión, preparación con placebo y aleatorización (visitas 1, 2, 3 y 4)
    1. Firma del consentimiento informado con anterioridad a la realización de cualquiera
    de los procedimientos específicos del ensayo
    2. Diagnóstico de diabetes mellitus tipo 2
    3. Hombres y mujeres de ?18 años, estableciéndose el límite máximo de edad por las
    restricciones locales en la ficha técnica de la metformina
    4. Dosis estable de terapia combinada de metformina ?1500 mg/día y la dosis máxima tolerada, que debe ser al menos la mitad de la dosis máxima de sulfonilurea durante al menos 8 semanas antes de la inclusión.
    5. Criterios de inclusión por HbA1c:
    ? En la inclusión (visita 1) ? valores de laboratorio de la visita de selección:
    ?7,7% y ?11,0%.
    ? En la visita de aleatorización (visita 4) ? valores de laboratorio de la visita 3:
    ?7,0% y ?10,5%.
    6. Solo para mujeres: Mujeres sin capacidad fértil o mujeres en edad fértil que
    cumplan los siguientes criterios:
    ? Uso de métodos altamente efectivos para el control de natalidad (ver más abajo)
    para evitar gestaciones a lo largo del ensayo y durante 4 semanas más una vez
    concluido el ensayo
    Tener una prueba de embarazo negativa en orina (sensibilidad mínima 25 UI/l o
    unidades equivalentes de HCG) en las 72 horas previas al comienzo del ensayo
    y en cada visita
    E.4Principal exclusion criteria
    The following criteria apply to the enrolment, placebo lead-in and randomisation visits (Visits 1, 2, 3, and 4)
    Endocrine and metabolic disorders
    Diagnosis of Type 1 diabetes mellitus, known diagnosis of MODY or secondary diabetes mellitus
    History of diabetic ketoacidosis
    Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment
    FPG >270 mg/dL (>15 mmol/L) ? assessed based on laboratory results from Visits 1, 2 and 3
    BMI >45 kg/m2
    History of bariatric surgery (ie, any surgery to treat obesity; for example, gastric banding or procedures that involve bypassing or transposing sections of the small intestine). History of liposuction is allowed
    Diabetes insipidus
    Thyroid-stimulating hormone (TSH) and free T4 values outside normal range; an abnormal TSH value needs to be followed up with a free T4 test. Patients with abnormal free T4 values will be excluded
    Cardiovascular disorders
    Recent Cardiovascular Events in a patient:
    Acute Coronary Syndrome (ACS) within 2 months prior to enrolment
    Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment
    Acute Stroke or TIA within 2 months prior to enrolment
    Less than 2 months post coronary artery revascularization prior to enrolment
    Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure.
    Blood pressure:
    At enrolment (Visit 1): Systolic BP ?170 mmHg and/or diastolic BP ?110 mmHg
    At randomisation (Visit 4): Systolic BP ?160 mmHg and/or diastolic BP ?100 mmHg
    Kidney or urological disorders
    Measured serum creatinine value of ?1.5 mg/dL (133 ?mol/L) for male patients and ?1.4 mg/dL (124 ?mol/L) for female patients or renal function that would preclude treatment with metformin according to local guidance
    History of unstable or rapidly progressing renal disease
    Familial renal glucosuria. This condition is diagnosed as glucosuria (>1.0 mmol/L urine) in the presence of normoglycaemia in patients without the diagnosis of diabetes mellitus
    History of unexplained microscopic or gross hematuria, or microscopic hematuria at visit 1, confirmed by a follow-up sample at next scheduled visit, where according to the investigator a satisfactory evaluation of hematuria has not been conducted based on guidance in section 6.4.9.3
    Hepatic disorders
    Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
    Total bilirubin >2.0 mg/dL (34.2 µmol/L)
    Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
    History of drug-induced liver enzyme elevations
    History of severe hepatobiliary disease or hepatotoxicity with any medication
    Hematologic/oncologic disorders/conditions
    Haemoglobin <10 g/dL (<100 g/L) or 6.2 mmol/L for men; haemoglobin <9.0 g/dL (<90 g/L) or 5.9 mmol/L for women
    History of chronic haemolytic anaemia or haemoglobinopathies (for example, sickle cell anaemia, thalassemia, sideroblastic anaemia). Mild haemolysis due to artificial heart valves or due to sickle cell trait is not an exclusion criterion except when haemoglobin levels are too low (as defined in haemoglobin criteria above)
    Iron deficiency anaemia with iron therapy started in the past 12 weeks prior to enrolment visit, or a recent diagnosis of iron deficiency anaemia that requires therapeutic management within the next 24 weeks in the judgement of the investigator
    Donation or transfusion of blood, plasma, or platelets within the past 12 weeks prior to enrolment
    History of malignancy within the last 5 years prior to enrolment, excluding successful treatment of basal or squamous cell skin cancer
    Infectious disease/immunologic disorders
    Known immunocompromised status, including patients who underwent organ transplantation
    Musculoskeletal disorders
    Creatine Kinase (CK) >3x ULN
    History of drug-induced myopathy or drug-induced CK elevation
    Reproductive status
    Pregnant or breastfeeding patients
    Prohibited medications
    Use of any anti-hyperglycaemic medications other than metformin or sulfonylurea during the 10 weeks prior to enrolment
    Use of weight loss medication, including but not limited to sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylproprion, methamphetamine, and/or phendimetrazine, within 30 days prior to enrolment
    Treatment with systemic glucocorticoids equivalent to oral prednisolone ?10 mg (betamethasone ?1.2 mg, dexamethasone ?1.5 mg, hydrocortisone ?40 mg) per day within 30 days prior to enrolment; Treatment with single injections of systemic glucocorticoids, topical or inhaled corticosteroids are allowed
    Los siguientes criterios se aplican a las visitas de inclusión, preparación con placebo y aleatorización (visit. 1, 2, 3 y 4) Trast. endocrinos y metabólicos 1. Diagnóstico de diabetes mellitus tipo 1, diagnóst. conocido de diabetes tipo MODY o diabetes mellitus secundaria 2. Historia de cetoacidosis diabética 3. Síntomas de diabetes mal controlada como, entre otros, polidipsia y poliuria marcada y/o una pérdida de peso superior al 10% en los tres meses previos a la inclusión 4. GPA >270 mg/dl (>15 mmol/l) ?en base a los resultados de lab. en las visit. 1, 2 y 3. 5. IMC >45 kg/m2 6. Antecedente de cirugía bariátrica (a saber, cualquier cirugía para tto. de la obesidad; por ejemplo cerclaje gástrico o procedimientos de derivación o de transposición seccional del intestino delgado). Historia de liposucción está permitida 7. Diabetes insípida 8. Cifras de tirotropina (TSH) y T4 libre fuera de rango; un valor anormal de TSH requiere seguimiento con análisis de T4 libre. Los pac. con valores anormales de T4 libre quedarán excluidos Trastornos cardiovasculares 9. Acontecimientos cardiovasculares recientes en un paciente con: ? Síndrome coronario agudo (SCA) en los 2 meses previos a la inclusión. ? Hospitalización por angina inestable o infarto agudo de miocardio en los 2 meses previos a la inclusión. ? Ictus agudo o accidente isquémico transitorio en los 2 meses previos a la inclusión. ? Menos de 2 meses tras revascularización arterial coronaria antes de la inclusión. 10. Insuficiencia cardíaca congestiva de clase IV según los criterios de la New York Heart Association (NYHA), insuficiencia cardíaca aguda o inestable. Nota: Los pac. elegibles con insuf. cardíaca congestiva, especialmente los que reciben tto. diurético, deberían ser objeto de una cuidadosa monitorización de su estado volémico a lo largo del ensayo 11. Presión arterial: ? En la inclusión (visita 1): PA sistólica ?170 mmHg y/o PA diastólica ?110 mmHg ? En la aleatorización (visita 4): PA sistólica ?160 mmHg y/o PA diastólica ?100 mmHg Trastornos renales o urológicos 12. Valores de creatinina sérica ?1,5 mg/dl (133 µmol/l) en los varones y ?1,4 mg/dl (124 µmol/l) en las mujeres o función renal que podría excluir el tto. con metformina con arreglo a las guías locales 13. Historia de enfermedad renal inestable o rápidamente progresiva 14. Glucosuria renal familiar. Esta enfermedad se diagnostica como glucosuria (>1,0 mmol/l en orina) en presencia de normoglucemia en pacientes no diagnosticados de diabetes mellitus 15. Antecedentes de hematuria microscópica o macroscópica sin explicación o presencia de hematuria microscópica en la visita 1 y confirmada mediante una muestra de seguimiento en la visita siguiente cuando según el investigador no se haya realizado una valoración satisfactoria de la hematuria basada en las directrices de la Sección 6.4.9.3. Trast. hepáticos 16. Insuficiencia hepática severa y/o función hepática significativamente anormal definida como una cifra de aspartato aminotransferasa (AST) >3x límite superior de la normalidad (LSN) y/o alanina aminotransferasa (ALT) >3x LSN 17. Bilirrubina total >2,0 mg/dl (34,2 µmol/L) 18. Datos serológicos positivos de infección hepática actual, incluyendo presencia de anticuerpos IgM contra la hepatitis B vírica, antígeno de superficie de la hepatitis B y anticuerpos contra el virus de la hepatitis C 19. Antecedentes de elevaciones de las enzimas hepáticas inducidas por fármacos 20. Historia de enfermedad hepatobiliar grave o hepatotoxicidad secundaria a cualquier medicación Enfermedades y trastornos hematológicos/oncológicos 21. Hemoglobina <10 g/dl (<100 g/l) o 6,2 mmol/l en los hombres; hemoglobina <9,0 g/dl (<90 g/l) o 5,9 mmol/l en las mujeres 22. Historia de anemia hemolítica crónica o hemoglobinopatías (por ejemplo, anemia drepanocítica, talasemia, anemia sideroblástica). La hemólisis ligera provocada por prótesis valvulares cardíacas artificiales o debida a rasgo drepanocítico no es un criterio de exclusión excepto cuando las concentraciones de hemoglobina sean demasiado bajas (definidos en los criterios de hemoglobina enunciados anteriormente) 23. Anemia por déficit de hierro con terapia férrica iniciada en las 12 SEM.s previas a la visita de inclusión o diagnóstico reciente de anemia por déficit de hierro que, a juicio del investigador, requiera intervención terapéutica en las 24 SEM.s siguientes 24. Donación o transfusión de sangre, plasma, o plaquetas dentro de las 12 SEM.s previas a la inclusión 25. Antecedentes de neoplasia en los 5 años previos a la inclusión, exceptuando el cáncer de piel basocelular o epidermoide tratado con éxito Enfermedades infecciosas / trastornos inmunitarios
    26. Estados de inmunodeficiencia conocidos, incluidos los pacientes sometidos a trasplante de órganos
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    Primary outcome variable:
    · Change in HbA1c from baseline to week 24.
    Variables de eficacia
    Variable principal de valoración:
    Cambios en la HbA1c desde la situación basal hasta la semana 24
    Principales
    E.5.1.1Timepoint(s) of evaluation of this end point
    see E.5.1
    Ver E.5.1
    E.5.2Secondary end point(s)
    Key secondary outcome variables:
    · Change in fasting plasma glucose (FPG) from baseline to week 24.
    · Change in total body weight from baseline to week 24.
    · Proportion of patients achieving a therapeutic glycaemic response, defined as HbA1c <7.0% at week 24.
    · Change in seated systolic blood pressure (SBP) from baseline to week 8.
    Other secondary outcome variables:
    · Proportion of patients discontinued for lack of efficacy or rescued for failing to maintain FPG below pre-specified rescue criteria at weeks 4, 8, 16 and 24.
    · Change in HbA1c in patients with baseline HbA1c ?8.0% from baseline to week 24.
    · Change in HbA1c in patients with baseline HbA1c ?9.0% from baseline to week 24.
    · Change in FPG from baseline to week 8.
    · Change in seated SBP from baseline to week 24.
    · Proportion of patients with seated blood pressure of <130/80 mmHg at week 24 in patients with baseline elevated blood pressure (baseline SBP ?130 mmHg and/or baseline diastolic blood pressure (DBP) ?80 mmHg).
    · Percent change in fasting lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides) from baseline to week 24.
    · Change in HOMA-2, HOMA-IR from baseline to week 24.
    · Change in insulin, proinsulin and C-peptide values from baseline to week 24.
    · Change in waist circumference from baseline to week 24.
    · Effect of dapagliflozin versus placebo from baseline to week 24 on health-related quality of life (HRQL) as measured by Euro quality of life 5 Dimensions 3 levels (EQ-5D-3L).
    · Scores of treatment satisfaction, individual satisfaction and perceived frequency of hyper/hypoglycaemia as measured by Diabetes Treatment Satisfaction Questionnaire status (DTSQs) at baseline, week 24 and at week 52.
    · Scores of change of treatment satisfaction, individual satisfaction and perceived frequency of hyper/hypoglycaemia using the Diabetes Treatment Satisfaction Questionnaire change (DTSQc) observed with dapagliflozin versus placebo at week 52.
    · To assess HRQL- (EQ-5D-3L), weight related quality of life (SHIELD-WQ-9, IWQOL-Lite) and treatment satisfaction (DTSQc and DTSQs) over 52 weeks of treatment.
    Exploratory
    · Effects of dapagliflozin and placebo on weight related quality of life as measured by SHIELD-WQ-9.
    · Effects of dapagliflozin and placebo on weight related quality of life as measured by IWQOL-Lite.
    Safety
    · AEs, including adjudication of CV events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycaemic events and physical examination findings.
    Ppales variables de valoración secundarias ? Cambios en la glucemia plasmática en ayunas (GPA) desde el momento basal hasta la sem. 24
    ? Cambios en el peso corporal total desde el momento basal hasta la semana 24
    ? Proporción de pac. que alcanzan una respuesta glucémica terapéutica definida
    como una HbA1c < 7,0% en la sem. 24
    Cambios en la presión arterial sistólica en sedestación (PAS) desde el momento
    basal hasta la sem. 8
    Otras variables de valoración secundarias:
    ? Proporción de pac. que abandonaron el ensayo por falta de eficacia o necesidad de tto. de rescate por no mantener una GPA por debajo de los criterios de rescate pre-especificados en las semanas 4, 8, 16 y 24
    ? Cambios en la HbA1c en pac. con HbA1c basal ? 8,0% desde el momento basal hasta la semana 24
    ? Cambios en HbA1c en pac. con HbA1c basal ? 9,0% desde el momento basal
    hasta la sem. 24
    ? Cambios en la GPA desde el momento basal hasta la semana 8
    ? Cambios en la PAS en sedestación desde el momento basal hasta la sem. 24.
    ? Proporción de pac. con presión sistólica en sedestación < 130/80 mmHg en la
    sem. 24 que mostraban una presión arterial basal elevada (PAS basal ? 130
    mmHg y/o una presión diastólica basal (PAD) ?80 mmHg)
    ? Cambio porcentual de lípidos en ayunas (colesterol total, lipoproteínas de baja
    densidad, lipoproteínas de alta densidad y triglicéridos) desde el momento basal
    hasta la sem. 24
    ? Cambio en el HOMA-2 y HOMA-IR desde el momento basal hasta la sem. 24
    ? Cambio en los valores de insulina, proinsulina y péptido C desde el momento basal hasta la sem. 24
    ? Cambio en el perímetro de cintura desde el momento basal hasta la sem. 24
    ? Efectos de dapagliflozina frente a placebo desde el momento basal hasta la sem. 24 sobre la calidad de vida relacionada con la salud (CdVRS) evaluada mediante el
    cuestionario europeo de calidad de vida de 5 dimensiones con 3 niveles en cada una
    (EQ-5D-3L)
    ? Puntuaciones de satisfacción con el tratamiento, satisfacción individual y frecuencia
    percibida de hiper/hipoglucemia medidas por el estado del Cuestionario de
    Satisfacción con el Tratamiento de la Diabetes (DTSQs) en el momento basal, en la sem. 24 y en la sem. 52
    ? Puntuaciones del cambio en la satisfacción con el tto., satisfacción
    individual y frecuencia percibida de hiper/hipoglucemia utilizando los cambios en
    el Cuestionario de Satisfacción con el Tratamiento de la Diabetes (DTSQc)
    observados con dapagliflozina frente a placebo en la semana 52
    ? Evaluar la CdVRS-(EQ-5D-3L), la calidad de vida relacionada con el peso
    (SHIELD-WQ-9, IWQOL-Lite) y la satisfacción con el tto. (DTSQc y
    DTSQs) a lo largo de 52 sem. de tto. Variables exploratorias Efectos de dapagliflozina y placebo en la calidad de vida relacionada con el peso
    evaluada por SHIELD-WQ-9
    ? Efectos de dapagliflozina y placebo en la calidad de vida relacionada con el peso
    evaluada por IWQOL-Lite
    Variables de seguridad
    ? AAs, incluyendo la adjudicación de acontecimientos CV, valores de laboratorio,
    electrocardiograma, pulso, presión arterial, episodios hipoglucémicos y hallazgos de
    la exploración física
    E.5.2.1Timepoint(s) of evaluation of this end point
    see E.5.2
    Ver E.5.2
    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 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) 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 No
    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 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 EEA40
    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
    Canada
    Czech Republic
    Germany
    Poland
    Slovakia
    Spain
    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
    The end of the study is defined as ?the last visit of the last patient undergoing the study?.
    El final del ensayo se define como ?la última visita del último sujeto que participe en el ensayo?.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 172
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 162
    F.4.2.2In the whole clinical trial 216
    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)
    After having completed or discontinued the study, patients will receive alternative anti-hyperglycaemic treatment according to the investigator's judgement and according to local medical practice.
    Después de completar el ensayo o de abandonarlo, los pacientes recibirán tratamiento antihiperglucémico alternativo de acuerdo al criterio del investigador y a las guías locales de práctica médica.
    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 Decision2011-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-11
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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