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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-002839-28
    Sponsor's Protocol Code Number:NN9535-3744
    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:2012-10-22
    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 number2012-002839-28
    A.3Full title of the trial
    A long-term, randomised, double-blind, placebo-controlled, multinational, multi-centre trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes
    Estudio a largo plazo, aleatorizado, doble ciego, controlado con placebo, multinacional y multicéntrico para evaluar los efectos cardiovasculares y otros efectos a largo plazo con semaglutida en sujetos con diabetes de tipo 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long-term, randomised, double-blind, placebo-controlled, multinational, multi-centre trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes
    Estudio a largo plazo, aleatorizado, doble ciego, controlado con placebo, multinacional y multicéntrico para evaluar los efectos cardiovasculares y otros efectos a largo plazo con semaglutida en sujetos con diabetes de tipo 2
    A.3.2Name or abbreviated title of the trial where available
    SUSTAIN? 6 ? Long term outcomes
    SUSTAIN? 6 ? Resultados a largo plazo
    A.4.1Sponsor's protocol code numberNN9535-3744
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1131-7227
    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 pointGlobal Clinical Registry (GCR,1452)
    B.5.3 Address:
    B.5.3.1Street AddressVandtaarnsvej 114, VTB
    B.5.3.2Town/ citySoeborg
    B.5.3.3Post codeDK-2860
    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
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsemaglutide
    D.3.9.1CAS number 910463682
    D.3.9.2Current sponsor codeNNC0113-0217
    D.3.9.4EV Substance CodeSUB31671
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.34
    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 placeboSolution for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous 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 14.1
    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 confirm that treatment with semaglutide does not result in an unacceptable increase in cardiovascular risk as compared to a pooled comparator group (including placebo and active comparators) in adults with type 2 diabetes. This is done by demonstrating that the upper limit of the 95% confidence interval (CI) of the hazard ratio for semaglutide versus comparators is less than 1.8 when comparing in a meta-analysis time to first occurrence of a major adverse cardiovascular event (MACE) using all MACEs accrued from all subjects included in all of the confirmatory phase 3a clinical trials.
    Confirmar que el tratamiento con semaglutida no provoca un aumento inaceptable del riesgo cardiovascular comparado con un comparador combinado, que incluye placebo y comparadores activos, en adultos con diabetes de tipo 2. Para ello, se intentará demostrar que el límite superior del intervalo de confianza (IC) del 95% del cociente de riesgos instantáneos para la semaglutida comparada con los comparadores es inferior a 1,8 cuando se compara en un metanálisis del tiempo transcurrido hasta la primera aparición de un acontecimiento cardiovascular adverso importante (MACE) utilizando todos los MACE acumulados a partir de todos los sujetos incluidos en todos los estudios clínicos confirmatorios en fase 3a.
    E.2.2Secondary objectives of the trial
    To assess the long-term safety and efficacy of semaglutide 0.5 mg and 1.0 mg once weekly compared to placebo, both added on to standard of care, in adults with type 2 diabetes at high risk for cardiovascular events.
    Evaluar la seguridad y eficacia a largo plazo de semaglutida 0,5 mg y 1,0 mg una vez a la semana comparada con placebo, ambos añadidos al tratamiento convencional en adultos con diabetes de tipo 2 y riesgo cardiovascular elevado.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Men and women with type 2 diabetes mellitus.
    - Age higher or equal to 50 years at screening and clinical evidence of cardiovascular disease or age higher or equal to 60 years at screening and subclinical evidence of cardiovascular disease.
    - Anti-diabetic drug naïve, or treated with one or two OAD(s), or treated with human NPH insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OAD(s).
    - HbA1c higher or equal to 7.0% at screening.
    ? Hombres y mujeres con diabetes mellitus de tipo 2.
    ? Edad mayor o igual a 50 años al realizarse las pruebas de selección y evidencia clínica de enfermedad cardiovascular, o edad mayor o igual 60 años al realizarse las pruebas de selección y evidencia subclínica cardiovascular.
    ? Sin tratamiento antidiabético anterior o tratado con uno o dos ADO, con NPH humana, con análogos de la insulina de acción prolongada o insulina premezclada, ambos tipos de insulina bien en monoterapia o bien en combinación con uno o dos ADO.
    ? HbA1c mayor o igual a 7,0% al realizarse las pruebas de selección.
    E.4Principal exclusion criteria
    - Type 1 diabetes mellitus.
    - Use of GLP-1 receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening.
    - Use of any DPP-IV inhibitor within 30 days prior to screening.
    - Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness.
    - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening.
    - History of chronic pancreatitis or idiopathic acute pancreatitis.
    - An acute coronary or cerebro-vascular event within the previous 14 days from Visit 2.
    - Currently planned coronary, carotid or peripheral artery revascularisation.
    - Chronic heart failure NYHA class IV.
    - Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma.
    - Personal history of non-familial medullary thyroid carcinoma.
    - Screening calcitonin higher or equal to 50 ng/L.
    ? Diabetes mellitus de tipo 1.
    ? Tratamiento con agonistas de los receptores del GLP-1 (exenatida, liraglutida, etc.) o pramlintida dentro de los 90 días anteriores a las pruebas de selección.
    ? Tratamiento con inhibidores de la DPP-IV dentro de los 30 días anteriores a las pruebas de selección.
    ? Tratamiento con una insulina distinta a la insulina basal o a la insulina premezclada dentro de los 90 días anteriores a las pruebas de selección (excepto en el caso de tratamiento a corto plazo relacionado con una enfermedad intercurrente).
    ? Descompensación aguda del control glucémico que requiere la intensificación inmediata del tratamiento para prevenir las complicaciones agudas de la diabetes (p. ej., cetoacidosis diabética) dentro de los 90 días anteriores a las pruebas de selección.
    ? Antecedentes de pancreatitis crónica o de pancreatitis idiopática aguda.
    ? Episodio coronario o cerebrovascular agudo dentro de los 14 días anteriores a la Visita 2.
    ? Revascularización coronaria, carotídea o periférica ya programada.
    ? Insuficiencia cardíaca crónica de la clase IV de la clasificación de la NYHA.
    ? Antecedentes personales o familiares de neoplasia endocrina múltiple de tipo 2 (NEM-2) o de carcinoma medular de tiroides familiar.
    ? Antecedentes personales de carcinoma medular de tiroides no familiar.
    ? Calcitonina mayor o igual a 50 ng/l en el momento de realizarse las pruebas de selección.
    E.5 End points
    E.5.1Primary end point(s)
    Time from randomisation to first occurrence of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.
    Tiempo transcurrido desde la aleatorización hasta la primera aparición de un MACE, que se define como fallecimiento por causa cardiovascular, infarto de miocardio no mortal o ictus no mortal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from randomisation to first occurrence of a major adverse cardiovascular event (MACE).
    Tiempo transcurrido desde la aleatorización hasta la primera aparición de un acontecimiento cardiovascular adverso importante (MACE)
    E.5.2Secondary end point(s)
    1 - Time from randomisation to first occurrence of an expanded composite cardiovascular outcome.
    2 - Time from randomisation to each individual component of the expanded composite cardiovascular outcome.
    3 - Change from baseline to last assessment during the treatment period in other treatment outcomes, including HbA1c, fasting plasma glucose, body weight, lipid profile, urinary albumin to creatinine ratio, vital signs, hypoglycaemic events, adverse events, antisemaglutide antibodies and patient reported outcome (PRO).
    ? Tiempo transcurrido desde la aleatorización hasta la aparición del primer desenlace cardiovascular compuesto ampliado.
    ? Tiempo transcurrido desde la aleatorización hasta la aparición de cada uno de los componentes específicos del desenlace cardiovascular compuesto ampliado.
    ? Cambio desde la evaluación inicial (basal) hasta la última evaluación durante el período de tratamiento en otros desenlaces del tratamiento, incluidas la HbA1c, la glucosa plasmática en ayunas, el peso corporal, el perfil lipídico, el cociente albúmina/creatinina en la orina, las constantes vitales, los episodios de hipoglucemia, los acontecimientos adversos, los anticuerpos para la semaglutida y los resultados comunicados por el paciente (PRO).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Time from randomisation up to end of Follow-up (up to max. 148 weeks)
    2. Time from randomisation up to end of Follow-up (up to max. 148 weeks)
    3. From randomisation to end of treatment (up to max. 143 weeks)
    1. Tiempo transcurrido desde la aleatorización hasta el final del período de seguimiento (hasta un máximo de 148 semanas)
    2. Tiempo transcurrido desde la aleatorización hasta la aparición del primer desenlace cardiovascular compuesto ampliado.
    3 Desde la aleatorización hasta el final del tratamiento (hasta un máximo de 143 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Evaluation of cardiovascular outcome
    Evaluación de efectos cardiovasculares
    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 Yes
    E.8.2.3.1Comparator description
    Dos dosis diferentes para test de IMP
    Two different doses of test IMP
    E.8.2.4Number of treatment arms in the trial4
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    European Union
    Algeria
    Argentina
    Australia
    Brazil
    Canada
    India
    Israel
    Malaysia
    Mexico
    Russian Federation
    Taiwan
    Thailand
    Turkey
    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
    Última Visita del Último Paciente
    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 months10
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days15
    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: 1630
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1630
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 490
    F.4.2.2In the whole clinical trial 3260
    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)
    N/A
    No aplica
    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 Decision2012-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-15
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