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    Summary
    EudraCT Number:2015-002963-40
    Sponsor's Protocol Code Number:IDAPADM1
    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:2015-07-31
    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 number2015-002963-40
    A.3Full title of the trial
    Impact of treatment with Dapagliflozin (SGLT2 inhibitor) in metabolic control and glycemic pattern in type 1 diabetic patients
    IMPACTO DEL TRATAMIENTO CON DAPAGLIFLOZINA (INHIBIDOR DE SGLT-2) SOBRE EL CONTROL METABÓLICO Y EL PATRÓN GLUCÉMICO EN PACIENTES CON DM TIPO 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of treatment with Dapagliflozin in type 1 diabetic patients
    A.3.2Name or abbreviated title of the trial where available
    IDAPADM1
    A.4.1Sponsor's protocol code numberIDAPADM1
    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 SponsorDra Cristina Avendaño Sola
    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 supportNo
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Puerta de Hierro
    B.5.2Functional name of contact pointMaria Belen Ruiz Antoran
    B.5.3 Address:
    B.5.3.1Street AddressCalle Manuel de Falla 1
    B.5.3.2Town/ cityMajadahonda
    B.5.3.3Post code28222
    B.5.3.4CountrySpain
    B.5.4Telephone number34911917479
    B.5.5Fax number34911917650
    B.5.6E-mailmariabelen.ruiz@salud.madrid.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.3.1Product nameDapagliflozine
    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 INNDapagliflozine
    D.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeForxiga
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 diabetes
    Diabetes tipo 1
    E.1.1.1Medical condition in easily understood language
    Diabetes
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 diabetes mellitus
    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
    Assess the antidiabetic efficacy at short term, measured by HbA1c, of treatment with dapagliflozine in type 1 diabetic patients
    Determinar la eficacia antidiabética a corto plazo, medida en términos de hemoglobina glicosilada, del tratamiento con dapagliflozina en pacientes con DM tipo 1.
    E.2.2Secondary objectives of the trial
    (1)Evaluate the efficacy of dapagliflozine in terms of:
    *Ambulatory glucose profiles
    *Clinical and anthropometrics parameters
    *Biochemichal parameters
    (2)Evaluate safety of the treatment
    (3)Evaluate the grade of satisfaction of the antidiabetic treatment
    1) Evaluar la eficacia de dapagliflozina en relación a
    - Los perfiles de glucemia ambulatorios en pacientes con DM tipo 1.
    - Parámetros clínicos/antropométricos en pacientes con DM tipo 1.
    - Parámetros analíticos y marcadores de inflamación.
    2) Evaluar la seguridad de esta estrategia terapéutica.
    3) Determinar el grado de satisfacción del tratamiento antidiabético
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1)Women or men aged 18-55 years od oldf at the time of completion of the informed consent.
    (2)Written informed consent in conformity with local legislation obtaines before the performance of any procedure.
    (3)Patients with a diagnosis of type 1 diabetes mellitus (Diabetes diagnosed before 30 years old in a patient without overweight/obesity or diabetes diagnosed before 45 years old with evidence of positive pancreatic autoantibodies)
    (4)Treatment with multiple daily dose of insulin (1-2 injections of Glargina/Detemir with 3 injections of rapid insulin analogues) or continous subcutaneous insulin infusion therapy
    (5)HbA1c greater than 7% in at least two consecutive blood tests (separated at least for 3 months) performed during the past 6 months previous to the beginning of the study
    (1) Hombres o mujeres con edades comprendidas entre 18 y 55 años, ambos extremos incluidos, en el momento de la firma del consentimiento informado.
    (2) Consentimiento informado escrito conforme a ICH/GCP y a la legislación local, obtenido antes de cualquier procedimiento de estudio
    (3) Pacientes con diagnóstico de DM tipo 1 (DM diagnosticada antes de los 30 años de edad en ausencia de sobrepeso o DM diagnosticada antes de los 45 años con autoinmunidad pancreática positiva)
    (4) Tratamiento con múltiples dosis de insulina (1-2 inyecciones diarias de insulina Detemir o Glargina + 3 inyecciones preprandiales de análogo de insulina rápida) o infusión subcutánea continua al menos durante los 12 meses previos al inicio del estudio
    (5) HbA1c en mayor de 7% en al menos dos determinaciones consecutivas efectuadas en los 6 meses previos al inicio del estudio, separadas por un mínimo de 3 meses
    E.4Principal exclusion criteria
    (1)Inability to give inform consent in the absence of a legal guardian
    (2)Pregnancy or lactation
    (3)If there are any clijnical, biochemical, cognitive, social or psycosocial factors (considered by the investigador) that could negative influence the study or patient.
    (4)Liver disease (history of chronic liver disease or alteration in liver function tests: AST, ALT, bilirrubin, GGT)
    (5)Renal failure (MDRD < 60 ml/min)
    (6)History of multiple urinary tract or mycotic genital infections
    (7)History of baldder cancer
    (8)History of electrolyte disorders (SIADH, insipid diabetes, hyponatremia)
    (9)Treatment with loop diuretics
    (10)Haven received any drug under investigation, including antivirals, during the previous 6 months of starting the study.
    (1) Incapacidad para dar el consentimiento informado en la ausencia de un responsable legal.
    (2) Embarazo o lactancia
    (3) Si en opinión del investigador existen hallazgos en la exploración física, anomalías en los resultados de los análisis clínicos u otros factores médicos, cognitivos, sociales o psicosociales que pudieran influir negativamente
    (4) Hepatopatía (antecedente de enfermedad hepática crónica o alteración en las pruebas de función hepática: AST, ALT, GGT, Bilirrubina)
    (5) Insuficiencia renal (MDRD < 60 ml/min)
    (6) Infecciones urinarias o micóticas de repetición
    (7) Antecedente de cáncer de vejiga
    (8) Alteraciones del equilibrio hidroelectrolítico (diabetes insípida, SIADH, hiponatremias)
    (9) Tratamiento con diuréticos de asa
    (10) Haber recibido cualquier fármaco en investigación, incluidos antivirales de acción directa, en los 60 días anteriores a la administración del fármaco del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Mean value of HbA1c assessed at baseline and at the end of the 12 weeks of treatment with dapagliflozin
    Media de HbA1c. Se comparará dicho valor del periodo previo al tratamiento con el valor tras 12 semanas de tratamiento con dapagliflozina
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semanas
    E.5.2Secondary end point(s)
    (1)Mean value of HbA1c assessed at the end of treatment and at the end of follow-up period
    (2)Assessment of other variables related to metabolic control:
    a) Mean value of the following variables assessed at baseline and at the end of treatment and follow-up periods: fasting venous glucose, glucose in urine, dose of insulin (daily dose of prandial insulin, daily dose of basal insulin, total daily dose of insulin
    b)Mean value of the following parameters measured during continuous glucose monitoring periods:
    *Mean value of ambulatory glucose profiles
    *Glycemic exposure: area under the curve (mmol/L/hour)
    *Number of hypoglycemias (more tha 10 minutes under 70 mg/dL)
    *Percentage of time in the following glycemic ranges (mg/dL): <70; 70-180; >180; >250
    (3) Mean value of the following parameters related to glycemic variability measured during baseline (before treatment), during the first 6 days of treatment and during the last 6 days of treatment:
    a) SD: standard deviation (mg/dL)
    b)Coefficient of variation
    c)MAGE (mean amplitude of glycemic excursion)
    d)HBGI (high blood glucose index)
    e)LBGI (low blood glucose index)
    (4) Mean of the following clinical parameters assessed at baseline and at the end of treatment and follow-up periods: weight, abdominal circumference, BMI, body composition, systolis and diastolic blood pressure, heart rate
    (5) Mean of the following biochemical parameters assessed at baseline and at the end of treatment and follow-up periods: uric acid and C reactive protein
    (6) Safety and tolerance: assessed at baseline, at the end of treatment and in any required clinical situation:
    a)Physical examination
    b)Vital signs
    c)Laboratory tests: renal and hepatic profile, lipids, electrolytes and urynalisis
    d)Measurement of ketone bodies in plasma (this would be measured additionally every 15 days during the treatment period) and urine
    e)Report of adverse effects: laboratory values, values out of the normal range and descriptive statistics
    (7) Grade of treatment satisfaction (DTSQ)
    - Media de HbA1c Se comparará dicho valor tras el periodo de seguimiento (1 mes tras la retirada del tratamiento a estudio) respecto al nivel tras 12 semanas de tratamiento con dapagliflozina.
    - Otras variables relacionadas con el grado de control metabólico
    i. Cambio en las siguientes variables desde el valor basal hasta el valor obtenido al finalizar el período de tratamiento y el periodo de seguimiento:
    a. Glucemia venosa en ayunas
    b. Glucosa en orina
    c. Dosis de insulina: unidades totales de insulina prandial, unidades totales de insulina basal, dosis total diaria de insulina
    ii. Cambio de las siguientes variables durante los períodos de monitorización continua de glucosa:
    a. Glucemia media de los PGA
    b. Exposición glucémica: área bajo la curva (mmol/L/hora), durante los periodos de monitorización continua de glucosa
    c. Número de hipoglucemias (>10 minutos en glucemia < 70 mg/dL) durante los periodos de monitorización continua de glucosa.
    d. Porcentaje de tiempo en los siguientes rangos de glucemia (mg/dL):<70; 70-180; >180; >250; durante los periodos de monitorización continua de glucosa
    - Media en los parámetros de evaluación de la variabilidad glucémica (del periodo basal (previo al tratamiento) respecto al periodo inicial de tratamiento (primeros 6 días de tratamiento) y al periodo fin de tratamiento (últimos 6 días de tratamiento).
    i. SD ? desviación estándar (mg/dL)
    ii. Coeficiente de variación
    iii. MAGE (mean amplitude of glycemic excursion)
    iv. HBGI (high blood glucose index)
    v. LBGI (low blood glucose index)
    - Media en las siguientes variables clínicas desde el valor basal hasta el valor obtenido al finalizar el período de tratamiento y el periodo de seguimiento: peso, IMC, circunferencia abdominal, composición corporal (porcentaje de masa grasa y de masa libre de grasa) tensión arterial sistólica (TAS) y diastólica (TAD) y frecuencia cardiaca,
    - Medias en las siguientes variables analíticas desde el valor basal hasta el valor obtenido al finalizar el período de tratamiento y el periodo de seguimiento: ácido úrico en plasma y proteína C reactiva
    - Seguridad y tolerancia. Al inicio, al final del estudio y en las situaciones clínicas que lo requieran.
    i. Examen físico
    ii. Signos vitales
    iii. Pruebas de laboratorio que incluyen perfil renal, lipídico, electrolítico y hepático y análisis sistemático de orina
    iv. Presencia de cuerpos cetónicos en sangre capilar y en orina
    v. Efectos adversos (EA): listado por tratamiento, valores de laboratorio, valores fuera del rango de referencia y estadísticas descriptivas.
    Los pacientes incluidos en el estudio en todo momento tienen la posibilidad de contactar telefónicamente con los investigadores del estudio para comunicar la aparición de algún efecto adverso. En cada una de las visitas, se interrogará a los pacientes sobre la aparición de nuevas experiencias adversas desde la última visita y sobre la evolución de los acontecimientos adversos comunicados en visitas previas.
    Los acontecimientos adversos deben registrarse en las páginas correspondientes del CRD. Dicha anotación debe hacerse de manera concisa, empleando términos médicos convencionales y aceptables. Los acontecimientos adversos registrados no deben ser pruebas, evaluaciones o determinaciones clínicas, p.ej., resultados de laboratorio o signos vitales, pero debe reflejar el diagnóstico basado en la alteración observada. No obstante, si se suspende el tratamiento a causa de un resultado anómalo de laboratorio, debe anotarse la alteración (y no el propio resultado) en el apartado de acontecimientos adversos.
    - Grado de satisfacción del tratamiento antidiabético: mediante la utilización de un cuestionario validado para este fin (DTSQ) al inicio y al final del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 and 16 weeks
    12 y 16 semanas
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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
    The patients can stopthe participation in the study at any point. The investigator can withdraw a patient from the study if the patient does not comply with the rules of the protocol.
    Los pacientes podrán suspender su participación en el ensayo en el momento que lo desee. Así mismo, a su juicio y criterio, el investigador podrá decidir la retirada del paciente del ensayo, si no cumple las normal de protocolo
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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: 57
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state57
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-15
    P. End of Trial
    P.End of Trial StatusOngoing
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