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    Summary
    EudraCT Number:2012-000311-87
    Sponsor's Protocol Code Number:FFC-0001
    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:2012-02-28
    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 number2012-000311-87
    A.3Full title of the trial
    A long-term, randomized, open-labeled, parallel-group trial to compare the effects of liraglutide and sulphonilurea both in combination with metformin on clinical, endothelial and image markers of cardiovascular risk in patients with type 2 diabetes
    Ensayo clínico, aleatorio, abierto, de grupos paralelos para comparar el efecto de liraglutida con una sulfonilurea, ambos en combinación con metformina, sobre marcadores clínicos, endoteliales y de imagen en pacientes con diabetes tipo 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to compare the effect of liraglutide and glimepiride, both in combination with metformin in patients with type 2 diabetes
    Ensayo clínico para comparar el efecto de liraglutida con glimepirida, ambos en combinación con metformina en pacientes con diabetes tipo 2
    A.4.1Sponsor's protocol code numberFFC-0001
    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 SponsorFundación Fernández-Cruz
    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 supportNovo Nordisk España
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPICES SOLUCIONES S.L.
    B.5.2Functional name of contact pointJuan Luis Sanz
    B.5.3 Address:
    B.5.3.1Street AddressC/ Salamanca 7
    B.5.3.2Town/ cityTorrejón de la Calzada (Madrid)
    B.5.3.3Post code28991
    B.5.3.4CountrySpain
    B.5.4Telephone number+34918166804103
    B.5.5Fax number+34918169172
    B.5.6E-mailjuanluis.sanz@apices.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 holderNovo Nordisk A/S
    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 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 INNLIRAGLUTIDE
    D.3.9.1CAS number 204656-20-2
    D.3.9.3Other descriptive namehuman glucagon-like peptide-1 (GLP-1) analogue
    D.3.9.4EV Substance CodeSUB25238
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Amaryl
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis, S.A.
    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 INNGLIMEPIRIDE
    D.3.9.1CAS number 93479-97-1
    D.3.9.4EV Substance CodeSUB07925MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 4
    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: 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 Yes
    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 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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.1CAS number 1115-70-4
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    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 2 diabetes
    Diabetes 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 PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 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
    To assess the effect of treatment with liraglutide compared to glimepiride, as add-on to metformin, for one year on circulating levels of EPCs in patients with type 2 diabetes poorly controlled.
    Evaluar el efecto del tratamiento liraglutida durante un año sobre los niveles circulantes de las EPCs en pacientes con diabetes tipo 2 mal controlada en comparación con glimepirida.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of liraglutide compared to glimepiride, as add-on to metformin, with regards to other surrogate biomarkers of cardiovascular risk:
    - IMT
    - Central blood pressure
    - CD40 ligand (CD40L)
    - Highly sensitive c-reactive protein (hsCRP)
    - lipoprotein-associated phospholipase A2 (Lp-PLA2)
    - BNP

    We will also study the relationship between EPC levels and all these biomarkers.
    Other safety parameters of glycaemic control will also be measured: HbA1c, fasting plasma glucose (FPG) and other laboratory parameters (insulin, lipid profile, creatinine and albumin). They will also be correlated with EPC levels.
    Evaluar la eficacia de liraglutida sobre otros biomarcadores de riesgo cardiovascular: grosor intima-media (GIM), presión central, ligando de CD40 (CD40L), proteína C reactiva ultrasensible (PCR-us), lipoproteína asociada a la fosfolipasa A2 (Lp-PLA2) y péptido natriurético cerebral (BNP) en comparación con glimepirida.

    Se estudiará la relación entre los niveles de EPCs y estos biomarcadores.
    También se medirán los siguientes parámetros secundarios: HbA1c, glucosa en ayunas, y otros parámetros de laboratorio (insulina, perfil pipídico creatinia y albúmina), que también se correlacionarán con los niveles de EPC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed written consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject).
    2. Male or female patients between 18 and 75 years old;
    3. Subjects diagnosed with type 2 diabetes for more than 1 year
    4. Insulin naïve subjects (Allowed are: Previous short term insulin treatment < 28 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods < 14 days in total)
    5. Subjects previously treated with metformin at a minimum dose of 1500 mg/day
    6. HbA1c from 7% to 9%
    7. Adherence to injection therapy
    1. Pacientes que hayan otorgado el consentimiento informado por escrito antes de realizarle ningún procedimiento que no hubiera sido realizado según la práctica clínica habitual.
    2. Hombres y mujeres entre 18 y 75 años.
    3. Pacientes diagnosticados de diabetes tipo II hace al menos un año.
    4. Pacientes que no hayan recibido insulina (se permite que hayan recibido tratamientos cortos con insulina < 28 días totales; se permite que hayan recibido tratamiento durante hospitalización o diabetes gestacional < 14 días totales).
    5. Pacientes previamente tratados con metformina a dosis de al menos 1500 mg/día.
    6. HbA1c entre 7% y 9%.
    7. Aceptar tratamiento con inyecciones.
    E.4Principal exclusion criteria
    1. Type 1 diabetic patients;
    2. Use of a GLP-1 receptor agonist (exenatide, liraglutide or other), pramlintide, thiazolidinediones or any DPP-4 inhibitor within the 3 months prior to screening;
    3. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (or their partners). Adequate contraceptive measures are considered the use of hormonal based contraceptives in combination with a barrier contraception,
    4. Patients with a clinical history of serious cardiovascular events in the last 3 months (myocardial infarction, unstable angina, cerebral infarction, TIA, peripheral arteriopathic event);
    5. Suspected or confirmed acute pancreatitis;
    6. Personal history of medullary thyroid carcinoma);
    7. Patients with congestive heart failure (NYHA I-IV);
    8. Moderate or severe renal failure (creatinine clearance <60 ml/min);
    9. Patients with hepatic failure. This is AST or ALT > 3 times the upper limit of normal, history of cirrhosis or hepatitis;
    10. Patients with cancer in the last 10 years;
    11. Patients with terminal diseases;
    12. Patients unlikely to comply with trial procedures;
    13. Known psychiatric disease which may interfere with study procedure;
    14. Any other pathology which may interfere with the study results at the investigator?s discretion;
    15. Known or suspected contraindications to or history of hypersensitivity to the trial product or related products;
    16. Previous participation in this trial i.e. randomised;
    17. The receipt of any investigational product within 30 days.
    1. Pacientes con diabetes tipo 1.
    2. Tratamiento con agonistas de los receptors de GLP-1 (exenatida, liraglutida u otros) o pramlintida o cualquier inhibidor de la enzima DPP-4 en los 3 meses anteriores a la inclusión en el estudio.
    3. Mujeres embarazadas o en periodo de lactancia o que están intentando quedarse embarazadas o que no utilizan métodos anticonceptivos adecuados. Se consideran métodos anticonceptivos adecuados el uso de anticonceptivos hormonales en combinación con métodos de barrera.
    4. Historia de eventos cardiovasculares graves en los últimos 3 meses (infarto de miocardio, angina inestable, TIA, arteriopatía periférica).
    5. Pancreatitis (o con sospecha de padecerla).
    6. Carcinoma tiroideo.
    7. Insuficiencia cardiaca congestiva (NYHA I-IV).
    8. Insuficiencia renal moderada o severa (aclaramiento de creatinina <60 ml/min).
    9. Insuficiencia hepática media, moderada o severa (AST o ALT > 3 x LSN, historia de cirrosis o hepatitis).
    10. Pacientes con historial de enfermedad proliferativa en los últimos 10 años.
    11. Enfermedad terminal.
    12. Pacientes incapaces de cumplir con el protocolo del estudio.
    13. Enfermedad psiquiátrica conocida que puede interferer con los procedimientos del estudio.
    14. Pacientes con cualquier otra patología que, a juicio del investigador, pueda interferir con los resultados del estudio.
    15. Pacientes con hipersensibilidad a los productos del estudio.
    16. Participación previa en este estudio (paciente aleatorizado previamente).
    17. Haber recibido algún producto en investigación en los últimos 30 días.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the change in circulating levels of EPCs after 12 months (Visit 7) of treatment from baseline (Visit 2).
    Cambio en los niveles de EPC circulantes después de 12 meses de tratamiento, entre visita 7 y visita 2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 12 months of treatment
    Después de 12 meses de tratamiento
    E.5.2Secondary end point(s)
    The secondary endpoints will be to compare the following parameters between the treatment arms: IMT, central blood pressure, CD40L, hsCRP, Lp-PLA2, BNP.
    These secondary endpoints are define similarly to the primary endpoint as the change from baseline (Visit 2) to after 12 months (Visit 7).

    The following endpoints will also be measured as secondary parameters:
    ? HbA1c
    ? FPG
    ? Biochemistry: insulin, creatinine, albumin and lipid profile (total cholesterol, LDL-c, HDL-c, triglycerides).
    Evaluar la eficacia de liraglutida sobre otros biomarcadores de riesgo cardiovascular: grosor intima-media (GIM), presión central, ligando de CD40 (CD40L), proteína C reactiva ultrasensible (PCR-us), lipoproteína asociada a la fosfolipasa A2 (Lp-PLA2) y péptido natriurético cerebral (BNP) en comparación con glimepirida.

    Se estudiará la relación entre los niveles de EPCs y estos biomarcadores.
    También se medirán los siguientes parámetros secundarios: HbA1c, glucosa en ayunas, y otros parámetros de laboratorio (insulina, perfil pipídico creatinia y albúmina), que también se correlacionarán con los niveles de EPC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    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 Yes
    E.8.2.3.1Comparator description
    glimepirida
    glimepiride
    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
    Last visit of the last subject undergoing the trial
    La última visita del último paciente incluido en el estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state50
    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)
    At the end of the study the patient will receive treatment at investigator discretion
    Al finalizar el estudio el paicente recibirá tratamiento a criterio del investigador
    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 Decision2012-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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