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    Summary
    EudraCT Number:2018-003141-42
    Sponsor's Protocol Code Number:EX9924-4473
    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: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 number2018-003141-42
    A.3Full title of the trial
    Semaglutide cardiovascular outcomes trial in patients with type 2 diabetes
    Estudio de resultados cardiovasculares con semaglutida en pacientes con diabetes tipo 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A heart disease study of semaglutide in patients with type 2 diabetes
    Estudio de las enfermedades del corazón con semaglutida en pacientes con diabetes tipo 2
    A.3.2Name or abbreviated title of the trial where available
    SOUL
    SOUL
    A.4.1Sponsor's protocol code numberEX9924-4473
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1218-5368
    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 SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointClinical Disclosure (1452)
    B.5.3 Address:
    B.5.3.1Street AddressNovo Allé
    B.5.3.2Town/ cityBagsværd
    B.5.3.3Post code2880
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.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 nameSemaglutide 3 mg
    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 INNsemaglutide
    D.3.9.1CAS number 910463-68-2
    D.3.9.3Other descriptive nameSEMAGLUTIDE
    D.3.9.4EV Substance CodeSUB32188
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 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 nameSemaglutide 7 mg
    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 INNsemaglutide
    D.3.9.1CAS number 910463-68-2
    D.3.9.3Other descriptive nameSEMAGLUTIDE
    D.3.9.4EV Substance CodeSUB32188
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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: 3
    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 nameSemaglutide 14 mg
    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 INNsemaglutide
    D.3.9.1CAS number 910463-68-2
    D.3.9.3Other descriptive nameSEMAGLUTIDE
    D.3.9.4EV Substance CodeSUB32188
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Diabetes Mellitus, Type 2
    Diabetes Mellitus tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    Diabetes tipo 2
    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 demonstrate that oral semaglutide lowers the risk of major adverse cardiovascular events compared to placebo, both added to standard of care in patients with type 2 diabetes and at high risk of cardiovascular events.
    Demostrar que semaglutida oral reduce el riesgo de acontecimientos adversos cardiovasculares importantes en comparación con placebo, añadidos ambos al tratamiento habitual en pacientes con diabetes tipo 2 y alto riesgo de sufrir acontecimientos cardiovasculares.
    E.2.2Secondary objectives of the trial
    To compare the effects of oral semaglutide versus placebo, both added to standard of care in patients with type 2 diabetes and at high risk of cardiovascular events with regards to:
    - Chronic kidney disease
    - Cardiovascular events
    - Peripheral artery disease
    - Glycaemic control and body weight
    - Safety
    Comparar los efectos de semaglutida en comparación con placebo, añadidos ambos al tratamiento habitual en pacientes con diabetes tipo 2 y alto riesgo de sufrir acontecimientos cardiovasculares en lo que respecta a:
    - Nefropatía crónica
    - Acontecimientos cardiovasculares.
    - Arteriopatía periférica
    - Control de la glucemia y peso corporal
    - Seguridad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, age 50 years or older at the time of signing informed consent
    2. Diagnosed with type 2 diabetes mellitus
    3. HbA1c 6.5% - 10.0% (47 - 86 mmol/mol) (both inclusive) (Latest available and no more than 30 days old local laboratory assessment based on medical records or point of care measurement).
    4. At least one of the below conditions (a-d):
    a) Coronary heart disease defined as at least one of the following:
    i. Prior myocardial infarction
    ii. Prior coronary revascularisation procedure
    iii. Equal to or above 50% stenosis in coronary artery documented by cardiac catheterisation, computerized tomography coronary angiography
    iv. Coronary heart disease with ischaemia documented by stress test with any imaging modality
    b) Cerebrovascular disease defined as at least one of the following:
    i. Prior stroke
    ii. Prior carotid artery revascularisation procedure
    iii. Equal to or above 50% stenosis in carotid artery documented by X-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound
    c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following:
    i. Intermittent claudication with an Ankle-brachial index (ABI) below 0.85 at rest
    ii. Intermittent claudication with an equal to or above 50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound
    iii. Prior peripheral artery (excluding carotid) revascularization procedure
    iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis)
    d) Chronic kidney disease defined as:
    i. eGFR below 60 mL/min/1.73 m^2 (Based on medical records using latest available and no more than 6 months old assessment).
    1. Pacientes de ambos sexos, de ≥ 50 años de edad en el momento de la firma del consentimiento informado.
    2. Diagnóstico de diabetes mellitus tipo 2.
    3. HbA1c del 6,5%-10,0% (47-86 mmol/mol) (ambos inclusive)a.
    4. Al menos una de las circunstancias siguientes (a-d):
    a) Enfermedad coronaria, definida como al menos uno de lo siguiente:
    i. Infarto de miocardio previo
    ii. Procedimiento de revascularización coronaria previa
    iii. Estenosis ≥ 50% en la arteria coronaria documentada por cateterismo cardíaco o angiotomografía computarizada coronaria
    iv. Enfermedad coronaria con isquemia documentada mediante prueba de esfuerzo con cualquier modalidad de imagen.
    b) Enfermedad cerebrovascular definida como al menos uno de lo siguiente:
    i. Ictus previo
    ii. Procedimiento previo de revascularización de la arteria carótida
    iii. Estenosis ≥ 50% en la arteria carótida documentada por angiografía convencional, angiorresonancia magnética, angiotomografía computarizada o ecografía Doppler
    c) Arteriopatía periférica (AP) sintomática, definida como al menos uno de lo siguiente:
    i. Claudicación intermitente con índice tobillo-brazo (ABI) < 0,85 en reposo
    ii. Claudicación intermitente con estenosis ≥ 50% en una arteria periférica (excluida la carótida) documentada mediante angiografía convencional, angiorresonancia magnética, angiotomografía computarizada o ecografía Doppler
    iii. Procedimiento previo de revascularización de la arteria periférica (excluida la carótida)
    iv. Amputación de extremidades inferiores en o por encima del tobillo por enfermedad aterosclerótica (excepto traumatismo u osteomielitis)
    d) Nefropatía crónica, definida como:
    i. FGe < 60 ml/min/1,73 m2 b
    E.4Principal exclusion criteria
    1. Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
    2. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
    3. Heart failure presently classified as being in New York Heart Association Class IV
    4. Treatment with any glucagon-like peptide-1 receptor agonist within 30 days before screening
    1. Cualquiera de las circunstancias siguientes: infarto de miocardio, ictus u hospitalización por angina de pecho inestable o accidente isquémico transitorio en los 60 días previos al día de la selección.
    2. Revascularización arterial coronaria, carotídea o periférica programada el día de la selección.
    3. Insuficiencia cardíaca clasificada actualmente en la clase IV de la New York Heart Association (NYHA).
    4. Tratamiento con cualquier agonista del receptor del péptido glucagonoide-1 en los 30 días previos a la selección.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first occurrence of a major adverse
    cardiovascular event (MACE), a composite endpoint consisting of:
    - CV death
    - non-fatal myocardial infarction
    - non-fatal stroke
    Tiempo transcurrido desde el primer episodio de un acontecimiento adverso cardiovascular importante (MACE), un criterio de valoración combinado definido como:
    - muerte de origen cardiovascular,
    - infarto de miocardio no mortal
    - ictus no mortal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomisation (week 0) to end-of-trial (up to 61 months or more) (trial is event driven)
    Desde la aleatorización (semana 0) hasta el fin del ensayo (hasta 61 meses o más) (ensayo determinado por los episodios)
    E.5.2Secondary end point(s)
    1. Time to first occurrence of a composite endpoint consisting of:
    - cardiovascular death
    - renal death
    - onset of persistent equal to or above 50% reduction in eGFR (CKD-EPI) (Compared with baseline)
    - onset of persistent eGFR (CKD-EPI) below 15 mL/min/1.73 m^2
    - initiation of chronic renal replacement therapy (dialysis or kidney transplantation)
    2. Time to occurrence of cardiovascular death
    3. Time to first occurrence of major adverse limb events (MALE), a composite endpoint consisting of:
    - acute limb ischemia hospitalisation
    - chronic limb ischemia hospitalisation
    1. Tiempo transcurrido desde la primera aparición de un criterio de valoración combinado de:
    - muerte de origen cardiovascular
    - muerte de origen renal
    - aparición de una reducción persistente ≥ 50% de la filtración glomerular estimada (CKD-EPI) (en comparación con el valor basal)
    - inicio de una FGe persistente (CKD-EPI) < 15 ml/min/1,73 m2
    - inicio de un tratamiento de sustitución renal crónica (diálisis o trasplante de riñón)
    2. Tiempo transcurrido hasta la aparición de muerte de origen cardiovascular
    3. Tiempo transcurrido hasta la primera aparición de acontecimientos adversos importantes en las extremidades (MALE), un criterio de valoración combinado formado por:
    • hospitalización por isquemia aguda de las extremidades
    • hospitalización por isquemia crónica de las extremidades
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints:
    From randomisation (week 0) to end-of-trial (up to 61 months or more) (trial is event driven)
    Todos los criterios de valoración secundarios:
    Desde la aleatorización (semana 0) hasta el fin del ensayo (hasta 61 meses o más) (ensayo determinado por los episodios)
    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 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 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 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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA121
    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
    Algeria
    Argentina
    Brazil
    Canada
    China
    Colombia
    European Union
    Hong Kong
    India
    Israel
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Russian Federation
    Serbia
    South Africa
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days12
    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: 3857
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5785
    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 state190
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2667
    F.4.2.2In the whole clinical trial 9642
    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
    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 Decision2019-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-28
    P. End of Trial
    P.End of Trial StatusOngoing
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