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    Summary
    EudraCT Number:2019-000979-16
    Sponsor's Protocol Code Number:ESR-17-12784
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-06-11
    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 number2019-000979-16
    A.3Full title of the trial
    Dapagliflozin effect in the reduction of different abdominal fat layers in type 2 diabetic patients.
    Efecto de dapagliflozina en la reducción de diferentes capas de grasa abdominal en pacientes diabéticos tipo 2.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dapagliflozin effect in the reduction of abdominal fat layers in type 2 diabetic patients.
    Efecto de dapagliflozina en la reducción de la grasa abdominal en pacientes diabéticos tipo 2.
    A.3.2Name or abbreviated title of the trial where available
    OMENDAPA
    OMENDAPA
    A.4.1Sponsor's protocol code numberESR-17-12784
    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 SponsorDr. Guillem Cuatrecasas - CPEN S.L.
    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 Farmacéutica Spain, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCPEN S.L.
    B.5.2Functional name of contact pointDr. Guillem Cuatrecasas
    B.5.3 Address:
    B.5.3.1Street AddressViladomat 217 Atico B
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08029
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 600550127
    B.5.6E-mailgcuatrecasas@cpen.cat
    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 Metformin
    D.2.1.1.2Name of the Marketing Authorisation holderMetformin
    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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.3Other descriptive nameMetformin
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number850 to 1700
    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 Dapagliflozin
    D.2.1.1.2Name of the Marketing Authorisation holderDapagliflozin
    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 INNDaplagliflozin
    D.3.9.1CAS number 960404-48-2
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
    D.3.9.4EV Substance CodeSUB90205
    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
    Abdominal fat layers in type 2 diabetic patients
    Reducción de la capa de grasa omental en pacientes con diabetes tipo 2
    E.1.1.1Medical condition in easily understood language
    Abdominal fat layers in type 2 diabetic patients
    Reducción de la capa de grasa omental en pacientes con diabetes tipo 2
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    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 differences between both arms of treatment (metformin vs. metformin + dapagliflozin) regarding omental fat layer reduction after 6 months of treatment.
    Evaluar las posibles diferencias entre ambos grupos de tratamiento (metformina vs. metformina + dapagliflozina) con respecto a la reducción de la grasa omental después de 6 meses de tratamiento.
    E.2.2Secondary objectives of the trial
    - Correlation between thickness of omental layer and cardiovascular risk measurements and comparisons between both arms of treatment.
    - Percentage of patients who were able to reduce their omental fat under 37 mm (females) and 54 mm (males) after 6 months of treatment.
    - Evaluate the changes in the thickness of the different abdominal fat layers to be analysed and compare the results between treatment arms.
    - Identify other potential layers of abdominal fat (e.g. pre-peritoneal) that may correlate with glycaemic control (HbA1c), clinical criteria for metabolic syndrome, or cardiovascular risk markers.
    - Correlación entre el espesor de la capa omental y las mediciones de riesgo cardiovascular y las comparaciones entre ambos grupos de tratamiento.
    - Porcentaje de pacientes que pudieron reducir su grasa omental por debajo de 37 mm (mujeres) y 54 mm (hombres) después de 6 meses de tratamiento.
    - Evaluar los cambios en el grosor de las diferentes capas de grasa abdominal que se analizarán y comparar los resultados entre los brazos de tratamiento.
    - Identificar otras capas potenciales de grasa abdominal (por ejemplo, pre-peritoneal) que puedan correlacionarse con el control glucémico (HbA1c), los criterios clínicos para el síndrome metabólico o los marcadores de riesgo cardiovascular.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients of both sexes between the ages of 50 and 75 (both included) at the time of signature of informed consent form.
    2. Diagnosed of type-2 diabetes (defined as HbA1c level between6.5% and 9%) a maximum of 12 months prior to Informed Consent form signature.
    3. Treatment naive Patients (only diet and exercise as current treatments for glycemic control are permitted)
    4. BMI >30kg/m2 at baseline visit.
    5. Patients omental fat over 37 mm (females) and 54 mm (males) at baseline visit
    1. Pacientes de ambos sexos entre las edades de 50 y 75 años (ambos incluidos) en el momento de la firma del consentimiento informado.
    2. Diagnóstico de diabetes tipo 2 (definido como un nivel de HbA1c entre 6.5% y 9%) un máximo de 12 meses antes de la firma del consentimiento informado.
    3. Pacientes sin tratamiento previo (solo se permite el ejercicio físico y dieta como tratamientos para el control glucémico)
    4. IMC> 30kg / m2 en la visita basal.
    5. Pacientes con grasa omental de más de 37 mm (mujeres) y 54 mm (hombres) en la visita basal.
    E.4Principal exclusion criteria
    1. Not able or unwilling to sign the Informed Consent form.
    2. Other serious illness that according to Investigator criteria could compromise the patient follow-up during the study
    3. Patient is unable of follow the hypocaloric diet with a -500 Kcal/day deficiency.
    4. Previous use of other antidiabetic drugs
    5. Hepatic failure defined as:
    a. AST > 3X upper limits level compared to reference levels.
    b. ALT > 3X upper limits level compared to reference levels.
    c. Bilirrubin > 3X upper limits level compared to reference levels.
    6. Renal failure (defined as GF <60ml/min).
    7. Concomitant use of other diuretic drugs
    8. Recurrent Urinary Tract Infection (defined as more than 2 UTI´s in last year previous to inclusion)
    9. Women of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies
    10. A woman of childbearing potential must have a negative urine pregnancy test at screening within 10-14 days and 24 hours before commencing treatment. Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods for reliable birth control simultaneously.
    11. Simultaneous participation in a clinical trial for the duration of this study.
    1. El sujeto no puede o no está dispuesto a firmar el consentimiento informado.
    2. Otra enfermedad grave que, según los criterios del investigador, podría comprometer el seguimiento del paciente durante el estudio.
    3. El paciente no puede seguir la dieta hipocalórica con una deficiencia de -500 Kcal / día.
    4. Uso previo de otros fármacos antidiabéticos.
    5. Fallo hepático definido como:
    a. Nivel de límites superiores AST> 3X en comparación con los niveles de referencia.
    b. Nivel ALT> superiores a 3X en comparación con los niveles de referencia.
    c. Niveles Bilirrubina> superiores 3X en comparación con los niveles de referencia.
    6. Insuficiencia renal (definida como GF <60ml / min).
    7. Uso concomitante de otros medicamentos diuréticos.
    8. Infección recurrente del tracto urinario (definida como más de 2 UTI en el último año anterior a la inclusión)
    9. Las mujeres en edad fértil deben estar practicando un método anticonceptivo altamente efectivo que sea consistente con las regulaciones locales con respecto al uso de métodos anticonceptivos para sujetos que participan en estudios clínicos.
    10. Una mujer en edad fértil debe tener una prueba de embarazo de orina negativa en la prueba de detección dentro de los 10 a 14 días y 24 horas antes de comenzar el tratamiento. Las mujeres con alta capacidad reproductiva deben comprometerse a la abstención de las relaciones sexuales heterosexuales o a usar dos métodos anticonceptivos de forma simultánea
    11. Participación simultánea en un ensayo clínico durante la duración de este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Measurement of omental fat layer (mm thickness) through Abdominal Ultrasound (AU) at baseline and 6 months after treatment initiation, and comparisons in terms of reduction between both treatment arms.
    Medición de la capa de grasa omental (mm de espesor) a través de ultrasonido abdominal (AU) al inicio del estudio y 6 meses después del inicio del tratamiento, y comparaciones en términos de reducción entre ambos brazos de tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    E.5.2Secondary end point(s)
    6 months
    6 meses
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Analyze the presence of metabolic synd and comparison between groups
    -Analyze the insulin resistance of study population and comparison between groups
    - Analysis of reduction of the omental fat layer after 6 months of treat and it´s correlation with the following measurements
    - Achievement of omental fat layer levels under 37 mm (F) and 54 mm (M) through AU and comparisons between groups
    - Measurement of the different abdominal fat layers through AU at baseline and 6 months after treat initiation, and comparisons between groups
    - Correlation between the thickness of the different abdominal fat layers and total fat mass/BMI and comparisons between groups
    - Correlation between thickness of different abdominal layers with cardiovascular risk measurements and comparisons between groups
    - Analizar la presencia de sínd metabólico y la comparación entre grupos
    - Analizar la resistencia a la insulina de la población estudio y la comparación entre grupos
    - Análisis de la reduc de la capa de grasa omental tras 6 meses tto y su correlación con las sig mediciones
    - Logro de niveles de capa grasa omental <37mm (M) y <54mm (H) a través de EA y compara entre grupos
    - Medición de las dif capas de grasa abdominal a través de EA al inicio del estudio y tras 6 meses inicio tto, y comparaciones entre grupos
    - Correlación entre el grosor de las diferentes capas de grasa abdominal y la masa grasa total IMC y las comparaciones entre grupos
    - Correlación entre el grosor de las diferentes capas abdominales con las mediciones de riesgo cardiovascular y las comparaciones entre grupos
    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) 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 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) Yes
    E.8.2.2Placebo No
    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
    Último paciente última visita
    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 months12
    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: 44
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state88
    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)
    According to the medicine clinical practice
    Acorde a 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 Decision2019-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-28
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