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    Summary
    EudraCT Number:2014-000904-88
    Sponsor's Protocol Code Number:1218.149
    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:2014-07-04
    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 number2014-000904-88
    A.3Full title of the trial
    A 24 week randomized, double-blind, placebo-controlled, parallel group, efficacy and safety trial of once daily linagliptin, 5 milligrams orally, as add on to basal insulin in elderly Type 2 Diabetes Mellitus patients with insufficient glycaemic control
    Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, de 24 semanas de duración, de la eficacia y la seguridad de linagliptina 5 mg una vez al día por vía oral como tratamiento complementario a la insulina basal en pacientes ancianos con diabetes mellitus tipo 2 con un control insuficiente de la glucemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    linagliptin as add on to basal insulin in the elderly
    linagliptina como tratamiento complementario a la insulina basal en pacientes ancianos
    A.4.1Sponsor's protocol code number1218.149
    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 SponsorBoehringer Ingelheim España, S.A.
    B.1.3.4CountrySpain
    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 supportBoehringer Ingelheim España, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+1-800-243-0127
    B.5.5Fax number+1-800-821-7119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 Yes
    D.2.1.1.1Trade name Trajenta
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTrajenta
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Type 2 Diabetes Mellitus
    Diabetes Mellitus Tipo 2
    E.1.1.1Medical condition in easily understood language
    diabetes
    Diabetes
    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
    Change in glycated haemoglobin (HbA1c) after 24 weeks
    cambio de la HbA1c después de 24 semanas
    E.2.2Secondary objectives of the trial
    the proportion of patients experiencing at least one confirmed hypoglycaemic event during 24 weeks of treatment
    proporción de pacientes que experimenta al menos un acontecimiento hipoglucémico confirmado durante las 24 semanas de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation and Good Clinical Practice guidelines and local regulations prior to any evaluation and participation in the trial.
    - Male and female patients with a clinical diagnosis of Type 2 Diabetes Mellitus, at the time of Informed Consent, who are:
    - 70 years of age or older at informed consent or Screen Visit,
    - taking stable doses of basal insulin [strictly inclusive of: insulin neutral protamine Hagedorn and isophane insulin; insulin degludec; insulin detemir; and insulin glargine] for at least 4 weeks prior to randomisation (Visit 3) with dose adjustments up to a maximum of plus or minus 20% of baseline being allowed,
    - may or may not be taking metformin immediate release or extended release [if the patient is taking metformin, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (Visit 3)], and
    - may or may not be taking alpha-glucosidase inhibitors [acarbose, miglitol, and voglibose; if the patient is taking alpha-glucosidase inhibitors, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (Visit 3)].
    - Patients must have an glycosylated Haemoglobin of 7.5% (58 millimoles per mole) to 10.0% (86 millimoles per mole) at the first visit (Screen).
    - Patients must have a Body Mass Index of 45 kilogram/meter squared or less at the Screen Visit.
    - In the investigator's opinion, patients must be reliable, compliant, and agree to cooperate with all planned future trial evaluations as explained in detail during the informed consent process and to be able to perform them.
    -Los pacientes deben firmar y fechar un consentimiento informado conforme a las normas de Buena Práctica Clínica (GCP) según la Conferencia Internacional de Armonización (ICH) y la normativa local antes de participar y realizar cualquier tipo de evaluación en el estudio.
    - Pacientes hombres y mujeres con un diagnóstico clínico de T2DM en el momento de la firma del consentimiento informado, que:
    a. tienen 70 años de edad o más en el momento de la firma del consentimiento informado o de la visita de selección,
    b. han estado recibiendo dosis estables de insulina basal [exclusivamente: insulina protamina neutra Hagedorn (NPH) e insulina isófana; insulina deglutec; insulina detemir e insulina glargina] durante un mínimo de 4 semanas antes de la aleatorización (visita 3) con ajustes de dosis permitidos de hasta un máximo el +/- 20% de la dosis basal,
    c. están tomando o no metformina de liberación inmediata o de liberación sostenida [si el paciente toma metformina, las dosis se deben haber mantenido estables durante al menos 12 semanas sin que se produjeran ajustes de dosis antes de la aleatorización (visita 3)], y
    d. están tomando o no inhibidores de la alfa-glucosidasa [acarbosa, miglitol y voglibose; si el paciente toma inhibidores de la alfa-glucosidasa, las dosis se deben haber mantenido estables durante al menos 12 semanas sin que se produjeran ajustes de dosis antes de la aleatorización (visita 3)]
    - Los pacientes deben tener una HbA1c de entre el 7,5% [58 milimoles por mol (mmol/mol)] y 10,0% (86 mmol/mol) en la primera visita (selección).
    - Los pacientes deben tener un BMI de 45 kg/m2 o menos en la visita de selección.
    - En opinión del investigador, los pacientes deben ser fiables, cumplidores y cooperadores con las evaluaciones de estudio programadas que les fueron explicadas detalladamente durante el proceso de consentimiento informado y además deben tener la capacidad de someterse a las mismas.
    E.4Principal exclusion criteria
    - Impaired cognitive ability as supported by the Saint Louis University Mental Status Examination, additional assessment if necessary, and verified by the investigator at the Screen Visit.
    - Depressed mood as supported by a score of 10 or more on the Patient Health Questionnaire at the Screen Visit.
    - Type 1 Diabetes Mellitus as determined by past medical records and history.
    - Acute coronary syndrome (non-ST Elevation Myocardial Infarction, stroke or transient ischemic attack within 3 months prior to Screen Visit.
    - Indication of liver disease determined during Screen and/or Run-In Period, defined by a serum level above 3 times the upper limit of normal in any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase.
    - Bariatric, gastric bypass, and other gastrointestinal procedures or surgeries (including all types of gastric banding, restriction, and/or LapBand) with the objective of promoting weight loss within the past two years at Screen Visit.
    - Medical history of cancer (except for resected non-invasive basal or squamous cell carcinoma) and/or treatment for cancer within the last 5 years.
    - Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (malaria, babesiosis, haemolytic anaemia).
    - Un deterioro cognitivo diagnosticado mediante el Examen del Estado Mental de la Universidad de Saint Louis con pruebas adicionales si procede y verificado por el investigador en el momento de la visita de selección.
    - Estado de ánimo deprimido en base a una puntuación de 10 o más en el Cuestionario de Salud para pacientes.
    - Diabetes Mellitus tipo 1determinada en la historia clínica pasada del paciente.
    - Síndrome coronario agudo (infarto de miocardio sin elevación del segmento ST (STEMI), ictus o accidente isquémico transitorio en los 3 meses anteriores a la visita de selección.
    - Signos o síntomas de hepatopatía recogidos durante la visita de selección y/o el período de preinclusión, definida por un nivel sérico superior a tres veces el límite superior de la normalidad (ULN) de cualquiera de los parámetros siguientes: alanina aminotransferasa [ALT o transaminsasa glutamicopirúvica sérica (SGPT)], aspartato aminotransferasa [AST o transaminasa glutamicooxalacética sérica (SGOT)], o fosfatasa alcalina.
    - Cirugía bariátrica, bypass gástrico y otros procedimientos o intervenciones quirúrgicas gastrointestinales (incluido todo tipo de bandas gástricas, restricción gástrica y/o LapBand?) destinadas a fomentar la pérdida de peso en los dos años anteriores a la visita de selección.
    - Historia clínica de cáncer (excepto casos de carcinoma basal o carcinoma espinocelular no invasivo resecado) y/o tratamiento oncológico en los últimos 5 años.
    - Discrasias sanguíneas u otros trastornos que provoquen hemólisis o inestabilidad de los hematíes (p. ej. malaria, babesiosis, anemia hemolítica).
    E.5 End points
    E.5.1Primary end point(s)
    1: The primary endpoint in this trial is the change from baseline in HbA1c after 24 weeks of treatment.
    1: La variable principal es el cambio de la HbA1c respecto al momento basal después de 24 semanas de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: 24 weeks
    1: 24 semanas
    E.5.2Secondary end point(s)
    1: The key secondary endpoint, to be tested following the primary efficacy endpoint in a hierarchical order is the proportion of patients experiencing at least one confirmed hypoglycaemic event during 24 weeks of treatment.

    2: Proportion of patients with HbA1c on treatment <8.0% after 24 weeks of treatment

    3: Proportion of patients with HbA1c on treatment <7.5% after 24 weeks of treatment

    4: Proportion of patients with HbA1c lowering by at least 0.5% after 24 weeks of treatment

    5: Change from baseline in Fasting Plasma Glucose (FPG) after 24 weeks of treatment

    6: Incidence and intensity of Adverse Events

    7: Withdrawal due to Adverse Events

    8: Incidence of hypoglycaemic events
    1: La variable secundaria clave, que se estudiará después de la variable principal de la eficacia en un orden jerárquico, es la proporción de pacientes que experimenta al menos un acontecimiento hipoglucémico confirmado durante las 24 semanas de tratamiento.

    2: Proporción de pacientes con una HbA1c durante el tratamiento de <8,0% después de 24 semanas de tratamiento.

    3: Proporción de pacientes con una HbA1c durante el tratamiento de <7,5% después de 24 semanas de tratamiento.

    4: Proporción de pacientes con una disminución de la HbA1c de al menos un 0,5% después de 24 semanas de tratamiento.

    5: Cambio de la glucosa plasmática en ayunas (FPG) respecto al momento basal después de 24 semanas de tratamiento.

    6: Incidencia e intensidad de los acontecimientos adversos (AEs).

    7: Retirada debido a AEs.

    8: Incidencia de acontecimientos hipoglucémicos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: 24 weeks

    2: 24 weeks

    3: 24 weeks

    4: 24 weeks

    5: 24 weeks

    6: 24 weeks

    7: 24 weeks

    8: 24 weeks
    1: 24 semanas

    2: 24 semanas

    3: 24 semanas

    4: 24 semanas

    5: 24 semanas

    6: 24 semanas

    7: 24 semanas

    8: 24 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 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) 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Australia
    Belgium
    Colombia
    Denmark
    Finland
    Germany
    Greece
    Ireland
    Japan
    Mexico
    New Zealand
    Poland
    Romania
    South Africa
    Spain
    United Kingdom
    United States
    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
    LVLS
    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 months5
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 800
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1173
    F.4.2.2In the whole clinical trial 2198
    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)
    There is no specific plan for treatment after the patient completed participation in the trial.
    No hay ningún plan específico de tratamiento después de que el paciente haya completado la participación en el ensayo.
    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 Decision2014-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
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