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    Summary
    EudraCT Number:2011-004148-23
    Sponsor's Protocol Code Number:1218.22
    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:2013-08-14
    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 number2011-004148-23
    A.3Full title of the trial
    A multicenter, international, randomized, parallel group, double-blind, placebo-controlled, cardiovascular safety and renal microvascular outcome study with linagliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk
    Estudio multicéntrico, internacional, aleatorizado, en grupos paralelos, doble ciego y controlado con placebo sobre seguridad cardiovascular y resultados microvasculares renales con linagliptina, administrada en dosis de 5 mg una vez al día en pacientes con diabetes mellitus tipo 2 con alto riesgo vascular
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cardiovascular and renal microvascular outcome study with linagliptin in patients with type 2 diabetes mellitus at high vascular risk
    Estudio sobre seguridad cardiovascular y resultados microvasculares renales con linagliptina en pacientes con diabetes mellitus tipo 2 con alto riesgo vascular
    A.3.2Name or abbreviated title of the trial where available
    CARMELINA
    CARMELINA
    A.4.1Sponsor's protocol code number1218.22
    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 International GmbH
    B.1.3.4CountryGermany
    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 International GmbH
    B.4.2CountryGermany
    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+1800243 0127
    B.5.5Fax number+1800821 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 nameLinagliptin
    D.3.2Product code BI1356
    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 INN--
    D.3.9.1CAS number 668270-12-0
    D.3.9.2Current sponsor codeBI 1356
    D.3.9.3Other descriptive nameLINAGLIPTIN
    D.3.9.4EV Substance CodeSUB31340
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Diabetes Mellitus type 2
    Diabetes Mellitus tipo 2
    E.1.1.1Medical condition in easily understood language
    Diabetes Mellitus Type 2
    Diabetes Mellitus tipo 2
    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
    The primary objective is to demonstrate non-inferiority of treatment with linagliptin in comparison with placebo (as add-on therapy on top of standard of care) with respect to time to first occurrence of any of the adjudicated components of the primary composite endpoint in patients with type 2 diabetes mellitus
    El objetivo principal es demostrar la no inferioridad del tratamiento con linagliptina en comparación con el placebo (como tratamiento adicional al tratamiento habitual) con respecto al tiempo transcurrido hasta la primera aparición de alguno de los componentes incluidos en el criterio de valoración compuesto principal en pacientes con diabetes mellitus tipo 2
    E.2.2Secondary objectives of the trial
    If non-inferiority has been demonstrated, then the primary composite endpoint will be tested for superiority and the composite renal endpoint will be investigated separately with a test on superiority
    Si se demuestra la no inferioridad, se comprobará la superioridad del criterio de valoración compuesto principal, y el otro objetivo, evaluar el impacto del tratamiento con respecto al criterio de valoración compuesto renal se investigará por separado mediante una prueba de superioridad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Documented diagnosis of T2DM before visit 1(screening).
    2) Male or female patients who are drug-naïve or pre-treated with any antidiabetic background medication, excluding treatment with GLP-1 receptor agonists, DPP-4 inhibitors or SGLT-2 inhibitors if =>consecutive 7 days.
    3) Stable antidiabetic background medication (unchanged daily dose) for at least 8 weeks prior to randomization. If insulin is part of the background therapy, the average daily insulin dose should not have changed by more than 10% within the 8 weeks prior to randomization compared with the daily insulin dose at randomization.
    4) HbA1c of => 6.5% and <= 10.0% at Visit 1 (screening)
    5) Age => 18 years at Visit 1(screening). For Japan only: Age => 20 years at Visit 1
    6) Body Mass Index (BMI) <= 45 kg/m2 at Visit 1 (screening)
    7) Signed and dated written informed consent by date of Visit 1(screening) in accordance with Good Clinical Practice (GCP) and local legislation prior to any study related procedure
    8) High risk of CV events
    1. Diagnóstico documentado de DMT2 antes de la visita 1 (selección).
    2. Pacientes (hombres o mujeres) que no hayan recibido ningún fármaco o que hayan recibido previamente un tratamiento de base con algún medicamento antidiabético, excluidos quienes hayan recibido tratamientos con agonistas de los receptores del GLP-1, inhibidores de la DPP-4 o inhibidores del SGLT-2 si se administraron durante ? 7 días consecutivos.
    3. Medicamento de base antidiabético estable (sin cambio de dosis diaria) durante al menos 8 semanas antes de la aleatorización. Si la insulina forma parte de la terapia de base, la dosis de insulina diaria media no debería cambiarse en más del 10 % durante las 8 semanas anteriores a la aleatorización, en comparación con la dosis de insulina diaria asignada en el momento de la aleatorización.
    4. Hbg A1C de ? 6,5 % y ? 10,0 % en la visita 1 (selección).
    5. Edad ? 18 años en la visita 1 (selección). Solo para Japón: edad ? 20 años en la visita 1
    6. Índice de masa corporal (IMC) ? 45 kg/m2 en la visita 1 (selección).
    7. Consentimiento informado por escrito, firmado y fechado el día de la visita 1 (selección) según lo dispuesto en la legislación local y los principios de buenas prácticas clínicas (BPC) antes de la realización de todo procedimiento relacionado con el estudio.
    8. Alto riesgo de acontecimientos cardiovasculares
    E.4Principal exclusion criteria
    1) Type 1 diabetes mellitus.
    2) Treatment (=> 7 consecutive days) with GLP-1 receptor agonists, other DPP-4 inhibitors or SGLT-2 inhibitors prior to informed consent. Note: This also includes clinical trials where these antidiabetic drugs have been provided to the patient.
    3) Active liver disease or impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase (AP) => 3 x upper limit of normal (ULN) as determined at Visit 1.
    4) eGFR <15 ml/min (severe renal impairment or ESRD, MDRD formula), as determined during screening at Visit 1 and/or the need for maintenance dialysis.
    5) Any previous (or planned within next 12 months) bariatric surgery (open or laparascopic) or intervention (gastric sleeve).
    6) Pre-planned coronary artery re-vascularisation (PCI, CABG) or any previous PCI and/or CABG <= 2 months prior informed consent
    1) Diabetes mellitus tipo 1.
    2) Tratamiento (? 7 días consecutivos) con agonistas de GLP-1, otros inhibidores de DPP-4 o inhibidores de SGLT-2 antes del consentimiento informado. Nota: esto también incluye ensayos clínicos en los que se han suministrado estos fármacos antidiabéticos al paciente.
    3) Hepatopatía activa o función hepática alterada, definidas por unos niveles séricos de ALT (GPT sérica), AST (SGOT [GOT sérica]) o fosfatasa alcalina (FA) ? 3 x límite superior de la normalidad (LSN), determinados en la visita 1.
    4) FGe < 15 ml/min (alteración renal grave o ERT, fórmula de MDER), según lo determinado durante la selección en la visita 1, y/o necesidad de diálisis de mantenimiento.
    5) Cualquier intervención (manguito gástrico) o cirugía bariátrica (abierta o laparoscópica) previa (o planificada en los siguientes 12 meses).
    6) Revascularización arterial coronaria planificada previamente (ICP, IDAC) o cualquier ICP y/o IDAC previo ? 2 meses antes del consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    1: Time to the first occurence of any of the following adjudicated components of the primary composite endpoint (4-point MACE): CV death, non-fatal MI, non fatal stroke and hospitalization for unstable angina pectoris
    1: Tiempo transcurrido hasta la primera aparición de alguno de los siguientes componentes incluidos en el criterio de valoración compuesto principal (MACE de 4 puntos): muerte por causa cardiovascular, IM no mortal, ictus no mortal y hospitalización por angina de pecho inestable.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: 48 months
    1: 48 meses
    E.5.2Secondary end point(s)
    1: Time to first occurance of any of the following adjudicated components: CV death, non fatal MI and non fatal stroke (3-point MACE)

    2: Time to first occurance of any of the following adjudicated composite renal endpoint: renal death, end stage renal disease and a sustained decrease of 50% or more in eGFR
    1: Tiempo transcurrido hasta la primera aparición de alguno de los siguientes componentes incluidos en el criterio de valoración compuesto principal: muerte por causa cardiovascular, IM no mortal, ictus no mortal (MACE de 3 puntos)

    2: Tiempo transcurrido hasta la primera aparición de criterio de valoración compuesto renal: muerte por causa renal, ERT sostenida, reducción sostenida de un 50 % o más de la FGe
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: 48 months

    2: 48 months
    1: 48 meses

    2: 48 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 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA115
    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
    Argentina
    Brazil
    Bulgaria
    Canada
    China
    Czech Republic
    Hungary
    India
    Israel
    Japan
    Malaysia
    Mexico
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    South Africa
    Spain
    Taiwan
    United Kingdom
    United States
    Croatia
    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
    La última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days28
    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) Yes
    F.1.2.1Number of subjects for this age range: 6300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2000
    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 state225
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2644
    F.4.2.2In the whole clinical trial 10790
    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
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-18
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