Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-003298-40
    Sponsor's Protocol Code Number:SCALES
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-11-19
    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 number2014-003298-40
    A.3Full title of the trial
    STUDY OF THE EFFICACY AND SAFETY MANAGEMENT OF LIRAGLUTIDE IN TYPE 2 DIABETIC PATIENTS HOSPITALIZED WITH ACUTE CORONARY SYNDROME. IMPACT ON CARDIOVASCULAR RISK FACTOR.
    ESTUDIO DE LA EFICACIA Y SEGURIDAD DE LIRAGLUTIDA EN EL MANEJO DEL PACIENTE DIABÉTICO TIPO 2 HOSPITALIZADO CON SÍNDROME CORONARIO AGUDO. IMPACTO SOBRE FACTOR DE RIESGO CARDIOVASCULAR.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY OF THE EFFICACY AND SAFETY OF LIRAGLUTIDE IN TYPE 2 DIABETIC PATIENTS HOSPITALIZED WITH ACUTE CORONARY SYNDROME. IMPACT ON CARDIOVASCULAR RISK FACTOR.
    ESTUDIO DE LA EFICACIA Y SEGURIDAD DE LIRAGLUTIDA EN EL PACIENTE DIABÉTICO TIPO 2 HOSPITALIZADO CON SÍNDROME CORONARIO AGUDO. IMPACTO SOBRE FACTOR DE RIESGO CARDIOVASCULAR.
    A.3.2Name or abbreviated title of the trial where available
    SCALES
    SCALES
    A.4.1Sponsor's protocol code numberSCALES
    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 SponsorInstituto de Investigación La Fe
    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 supportInstituto de Investigación Sanitaria La Fe
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIIS La Fe
    B.5.2Functional name of contact pointUREC
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Fernando Abril Martorell106
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46026
    B.5.3.4CountrySpain
    B.5.4Telephone number+34961246611
    B.5.5Fax number+34961246620
    B.5.6E-mailinvestigacion_clinica@iislafe.es
    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 VICTOZA
    D.2.1.1.2Name of the Marketing Authorisation holderNovoNordisk
    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 nameliraglutide
    D.3.4Pharmaceutical form Solution for injection/infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 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 RoleComparator
    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 LANTUS
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis
    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 nameglargine insulin
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 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 2 DIABETIC HOSPITALIZED PATIENTS WITH ACUTE CORONARY SYNDROME.
    PACIENTE DIABÉTICO TIPO 2 HOSPITALIZADO CON SÍNDROME CORONARIO AGUDO.
    E.1.1.1Medical condition in easily understood language
    TYPE 2 DIABETIC HOSPITALIZED PATIENTS WITH ACUTE CORONARY SYNDROME.
    PACIENTE DIABÉTICO TIPO 2 HOSPITALIZADO CON SÍNDROME CORONARIO AGUDO.
    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 study the efficacy of glycemic control with the use of liraglutide in hospitals defined by glicosilated hemoglobin.
    - To study the impact of liraglutide on cardiovascular risk factors.
    - Estudiar la eficacia en el control glucémico con el uso de liraglutida en el medio hospitalario definido por la Hemoglogina glicosilada.
    - Estudiar el impacto de liraglutida en los factores de riesgo cardiovascular.
    E.2.2Secondary objectives of the trial
    - To study the safety of liraglutide in hospitals.
    - To study the usefulness of liraglutide in oxidative stress markers 3 months after the acute coronary event.
    - To study glycemic variability and incidence of hypoglycemia during hospitalization in patients included in each group.
    - To study the usefulness of 1.5 anhydroglucitol on these patients as an indirect measure of glycemic variability.
    - To study the efficacy of glycemic control with the use of liraglutide in hospitals defined by the mean pre and postprandial glycemia.
    - Estudiar la seguridad de liraglutida en el medio hospitalario.
    - Estudiar la utilidad de liraglutida en los marcadores de estrés oxidativo a 3 meses del evento coronario agudo.
    - Estudiar la variabilidad glucémica e incidencia de hipoglucemias durante la hospitalización en los pacientes incluidos en cada uno de los grupos.
    - Estudiar en estos pacientes la utilidad del 1,5 anhidroglucitol como medición indirecta de variabilidad glucémica.
    - Estudiar la eficacia en el control glucémico con el uso de liraglutida en el medio hospitalario definido por la glucemia media, pre y posprandial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 18-80 years hospitalized patients with acute coronary syndrome and diagnosed with type 2 diabetes for more than 3 months and an admission plasma glucose between 140-400 mg / dL.
    - In treatment with diet, oral agents in any combination or lower daily dose of insulin at 0.4 IU / kg.
    - Patients who have signed the Informed Consent.
    - Pacientes de entre 18-80 años hospitalizados con síndrome coronario agudo y diagnosticados de diabetes tipo 2 durante un tiempo mayor a 3 meses que presenten una glucemia al ingreso entre 140-400 mg/dL.
    - En tratamiento con dieta, antidiabéticos orales en cualquier combinación o dosis diaria de insulina inferior a 0.4 UI/kg.
    - Pacientes que hayan firmado el Consentimiento Informado.
    E.4Principal exclusion criteria
    - Those patients with admission plasma glucose> 400 mg / dL were excluded.
    - Patients with hyperglycemia on admission but without diagnosed diabetes.
    - Patients with a history of diabetic ketoacidosis.
    - Patients with a severe disease that may include cardiac surgery or intensive care stay.
    - Patients with a history of pancreatitis or biliary tract active disease .
    - Patients with hepatic or renal failure (GFR <60 mL / min / 1.73m2).
    - Pregnancy, lactation.
    - Mental disease.
    - Patients who do not sign the informed consent.
    - Patients with kidney, liver, adrenal, pituitary or thyroid gland problems.
    - Se excluirá a aquellos pacientes que presenten glucemia al ingreso >400 mg/dL.
    - Pacientes con hiperglucemia al ingreso pero sin diagnóstico de diabetes.
    - Pacientes con antecedentes de cetoacidosis diabética.
    - Pacientes con gravedad que pueda incluir cirugía cardíaca o estancia en cuidados intensivos.
    - Pacientes con antecedentes de pancreatitis o enfermedad activa de vías biliares.
    - Pacientes con fallo renal (FG < 60 mL/min/1.73m2) o hepático.
    - Embarazo, lactancia.
    -Trastorno mental.
    - Pacientes que no firmen el consentimiento para la participación en el estudio.
    -Pacientes con problemas de riñón, hígado, glándulas suprarrenales, hipófisis o glándula tiroidea.
    E.5 End points
    E.5.1Primary end point(s)
    - Efficacy of liraglutide:
    - Differences glycosylated hemoglogine recorded during the study.
    -Number Glycemia in the objectives range set in admission.
    - Impact of liraglutide CVRF
    - Change in SCORE cardiovascular risk corresponding to SPAIN.
    - Eficacia de liraglutida:
    - Diferencias de Hemoglogina glicosilada registrada durante el estudio.
    -Número de glucemias en el rango marcado como objetivos en ingreso hospitalario.
    - Impacto de liraglutida en FRCV:
    - Variación del SCORE de riesgo cardiovascular correspondiente a ESPAÑA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Hospital Admission
    -Hospital Stay
    -Hospital Discharge
    -Weekly phone Control (11 weeks)
    -Visit Week 12
    -Visit Week 16
    -Ingreso hospitalario
    -Estancia hospitalaria
    -Alta hospitalaria
    -Control teléfonico semanal (11 semanas)
    -Visita semana 12
    -Visita semana 16
    E.5.2Secondary end point(s)
    - Safety of Liraglutide:
    - Number of hypoglycaemia during hospitalization.
    - Number of severe hypoglycemia.
    - Risk of hypoglycemia determined by iPRO sensor calibration algorithm.
    - Risk of hyperglycemia determined by iPRO sensor calibration algorithm.
    - Number of glycemia out of range.
    - Utility liraglutide in oxidative stress markers:
    - Changes in the levels of oxidative stress markers from baseline after 3 months of treatment.
    - Glycemic variability and incidence of hypoglycemia:
    - Number of severe hypoglycemia during the entire hospitalization.
    - Risk of hypoglycemia determined by iPRO sensor calibration algorithm.
    - Comparison of glycemic variability using the standard deviation obtained by digital blood glucose and obtained iPRO sensor.
    - Utility of 1.5 anhydroglucitol:
    - Change in basal levels anhydroglucitol 1.5 and 3 months compared with previously obtained glycemic variability.
    - Seguridad de liraglutida:
    - Número de hipoglucemias durante el ingreso hospitalario.
    - Número de hipoglucemias graves.
    - Riesgo de hipoglucemia determinado por algoritmo calibrado en sensor iPRO.
    - Riesgo de hiperglucemia determinado por algoritmo calibrado en sensor iPRO.
    - Número de glucemias fuera de rango.
    - Utilidad de liraglutida en los marcadores de estrés oxidativo:
    - Variación en los niveles de marcadores de estrés oxidativo respecto al basal tras 3 meses de tratamiento.
    - Variabilidad glucémica e incidencia de hipoglucemias:
    - Número de hipoglucemias graves durante el ingreso hospitalario total.
    - Riesgo de hipoglucemia determinado por algoritmo calibrado en sensor iPRO.
    - Comparación de la variabilidad glucémica mediante la desviación estándar obtenida por glucemias digitales y obtenidas en sensor iPRO.
    - Utilidad del 1,5 anhidroglucitol:
    - Variación de los niveles 1,5 anhidroglucitol basal y a los 3 meses comparándolo con la variabilidad glucémica obtenida con anterioridad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Hospital Admission
    -Hospital Stay
    -Hospital Discharge
    -Weekly phone Control (11 weeks)
    -Visit Week 12
    -Visit Week 16
    -Ingreso hospitalario
    -Estancia hospitalaria
    -Alta hospitalaria
    -Control teléfonico semanal (11 semanas)
    -Visita semana 12
    -Visita semana 16
    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 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) 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
    -Subjects Liraglutide failing to achieve glycemic goals scored (a pattern of basal insulin as the basal-bolus group will be added.
    -Subjects Liraglutide group when the daily mean blood glucose> 240 mg / dL or two consecutive measurements are> 240 mg / dL, ( he will begin treatment with basal-bolus regimen with a total daily insulin dose of 0.5 IU / kg / day ).
    -Withdrawal Consent.
    -Investigator´s decision.
    -Sponsor´s decision.
    -Sujetos de liraglutida que no alcancen los objetivos glucémicos marcados (se añadirá una pauta de insulina basal como la del grupo basal-bolus).
    -Sujetos en grupo de liraglutida cuando la glucemia media diaria >240 mg/dL o dos medidas consecutivas se encuentren > 240 mg/dL, (comenzará tratamiento con pauta basal-bolus con una dosis diaria total de insulina de 0.5 UI/kg/día).
    -Retirada del consentimiento.
    -A criterio del investigador.
    -A criterio del promotor.
    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 months
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state80
    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)
    Patients will be followed-up as routine clinical practice.
    Los pacientes serán seguidos en consultas externas siguiendo la práctica clínica de rutina.
    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 Decision2014-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-09-18
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 05:36:19 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA