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    Summary
    EudraCT Number:2012-002603-17
    Sponsor's Protocol Code Number:1218.89
    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 number2012-002603-17
    A.3Full title of the trial
    A phase IIIb, multicenter, multinational, randomized, double-blind, placebo controlled, parallel group study to evaluate the glycemic and renal efficacy of once daily administration of linagliptin 5 mg for 24 weeks in type 2 diabetes patients, with micro- or macroalbuminuria (30-3000mg/g creatinine) on top of current standard treatment for diabetic nephropathy (Angiotensin Converting Enzyme inhibitor or Angiotensin Receptor Blocker) ? MARLINA (Efficacy, safety & Modification of Albuminuria in type 2 diabetes subjects with Renal disease with LINAgliptin)
    Estudio de fase IIIb, multicéntrico, multinacional, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia renal y sobre la glucemia de la administración de linagliptina 5
    mg una vez al día durante 24 semanas a pacientes con diabetes tipo 2 y micro o macroalbuminuria (30-3000 mg/g creatinina) y en tratamiento estándar actual para la nefropatía diabética (inhibidor de la enzima
    convertidora de la angiotensina o antagonista de los receptores de la angiotensina) ? MARLINA (Efficacy, safety & Modification of Albuminuria in type 2 diabetes subjects with Renal disease with LINAgliptin)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, safety & Modification of Albuminuria in type 2 diabetes subjects with Renal disease with LINAgliptin
    Eficacia, seguridad y modificación de la albuminuria en pacientes con diabetes tipo 2 con enfermedad renal con Linagliptina.
    A.3.2Name or abbreviated title of the trial where available
    MARLINA
    MARLINA
    A.4.1Sponsor's protocol code number1218.89
    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+18002430127
    B.5.5Fax number+18008217119
    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.3.4Pharmaceutical 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 INNLINAGLIPTIN
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeBI1356
    D.3.9.3Other descriptive nameLINAGLIPTIN
    D.3.9.4EV Substance CodeSUB31340
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    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 patients receiving current standard therapy for diabetic nephropathy (ACEi or ARB) with micro- or macroalbuminuria (UACR between 30 and 3000 mg/g creatinine). [ACEi=Angiotensin Converting Enzyme inhibitor; ARB=Angiotensin Receptor Blocker; UACR= Urinary Albumin Creatinine Ratio]
    Pacientes con diabetes tipo 2 sometidos a un tratamiento estándar actual para la nefropatía diabética (ACEi o ARB) con micro o macroalbuminuria (UACR entre 30 y 3000 mg/g creatinina). [ACEi = Inhibidor de la enzima convertidora de la angiotensina; ARB = Antagonista de los receptores de la angiotensina II; UACR = Cociente albúmina/creatinina en orina]
    E.1.1.1Medical condition in easily understood language
    Patients with Type 2 diabetes and albumin in the urine.
    Pacientes con diabetes tipo 2 y albúmina en la orina.
    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 SOC
    E.1.2Classification code 10027433
    E.1.2Term Metabolism and nutrition disorders
    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
    The objective of the current study is to investigate the glycemic efficacy and safety of linagliptin 5 mg given orally once daily for 24 weeks to type 2 diabetes patients with albuminuria (urinary albumin-to-creatinine ratio 30-3000 mg/g creatinine) on top of current standard therapy for diabetic nephropathy (ACEi or ARB).
    El objetivo de este estudio es investigar la eficacia y seguridad sobre la glucemia de linagliptina 5 mg administrada por vía oral una vez al día durante 24 semanas a pacientes con diabetes tipo 2 y albuminuria (cociente albúmina/creatinina en orina de 30-3000 mg/g creatinina) y en tratamiento estándar actual para la nefropatía diabética (ACEi o ARB).
    E.2.2Secondary objectives of the trial
    As a key secondary aim the study will adress anti-albuminuric potentials of linagliptin in patients at early stages of diabetic nephropathy with micro- or macroalbuminuria.
    El objetivo secundario principal clave evaluará el potencial anti-albuminúrico de linagliptina
    en paceintes con un estadía temprano de nefropatía diabética con micro-macroalbuminuria.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Diagnosis of type 2 diabetes mellitus
    ? 7%? HbA1c ? 10%
    ? Current standard therapy for diabetic nephropathy at stable dose for 10 weeks
    ? Urinary albumin-to-creatinine ratio (UACR): 30-3000 mg/g creatinine documented in the previous 12 months or detected at Screening.
    ? Estimated glomerular filtration rate, eGFR ? 30 ml/min.
    ? Age ?18 years but ? 80 years at Screening.
    - Diagnóstico de diabetes mellitus tipo 2
    - 7% ?HbA1c ? 10 %)

    - Tratamiento estándar actual para la nefropatía diabética. No se deben haber producido
    cambios en la dosis de la medicación antihipertensiva en las últimas 10 semanas.

    - Cociente albúmina/creatinina en orina (UACR): 30-3000 mg/g creatinina confirmado en los últimos 12 meses o detectado en la visita 1 (selección).

    - Filtración glomerular estimada, eGFR ? 30 ml/min

    - Edad ?18 años y ? 80 años en la visita 1 (selección).
    E.4Principal exclusion criteria
    ? Dual or triple blockade of the Renin Angiotensin System (RAS)
    ? Uncontrolled hyperglycaemia
    ? Mean arterial blood pressure > 110 mmHg
    ? Known hypersensitivity or allergy to the investigational product, or their excipients (including matching placebos).
    ? Treatment with a glitazone within 6 months prior to informed consent.
    ? Treatment with a DPP-4 inhibitor, a GLP-1 agonist, a SGLT2 inhibitor, a dopamin-agonist, a bile-acid sequestrant or insulin (except basal insulin) within 10 weeks prior to informed consent.
    ? Treatment with anti-obesity drugs 10 weeks prior to informed consent.
    ? Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator.
    ? Current treatment with systemic steroids (glucocorticoids) at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
    ? Participation in another trial with an investigational drug within 2 months prior to informed consent.
    - No está permitido el doble o triple bloqueo del sistema renina-angiotensina (RAS)
    - Hiperglucemia no controlada
    - Presión arterial media > 110 mmHg
    - Hipersensibilidad conocida o alergia al producto en investigación o a sus excipientes (inclusive los placebos correspondientes).
    - Tratamiento con glitazona durante los 6 meses anteriores al consentimiento
    informado.
    - Tratamiento con un inhibidor de la DPP-4, un agonista del GLP-1, un inhibidor del SGLT2, un agonista dopaminérgico, un secuestrador de ácidos biliares o insulina en las 10 semanas anteriores al consentimiento informado.
    - Tratamiento con fármacos contra la obesidad en las 10 semanas anteriores al consentimiento informado.
    - Alcoholismo o drogadicción en los 3 meses anteriores al consentimiento informado que pudiera interferir en la participación en el estudio, o cualquier otro trastorno que dificulte el cumplimiento de los procedimientos del estudio o la toma del fármaco del estudio en opinión del investigador.
    - Tratamiento actual con esteroides sistémicos (glucocorticoides) en el momento del consentimiento informado o cambio en la posología de las hormonas tiroideas en las 6 semanas anteriores al consentimiento informado
    - Participación en otro estudio de un fármaco experimental en los 2 meses anteriores al consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline in HbA1c
    La variable principale de este estudio son el cambio de la HbA1c respecto al valor basal
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    Después de 24 semanas de tratamiento
    E.5.2Secondary end point(s)
    The key secondary endpoint is the time weighted average of percentage change from baseline in UACR
    La variable secundaria clave es el cambio porcentual promedio en el tiempo de UACR
    respecto al valor basal
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    A lo largo de 24 semanas de tratamiento
    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 Yes
    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 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 concerned26
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Canada
    Finland
    France
    Germany
    Japan
    Korea, Republic of
    Philippines
    Spain
    Taiwan
    United States
    Vietnam
    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 = 18 July 2014
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial 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: 364
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 404
    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
    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 Decision2012-12-19
    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
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