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    Summary
    EudraCT Number:2013-001347-31
    Sponsor's Protocol Code Number:M13-954
    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:2013-09-12
    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 number2013-001347-31
    A.3Full title of the trial
    A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects with Diabetes Mellitus type 2
    Estudio doble ciego, aleatorizado, multicéntrico, de grupos paralelos y controlado con placebo para evaluar el efecto de Kreon® sobre la insuficiencia pancreática exocrina en sujetos con diabetes mellitus tipo 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects with Diabetes Mellitus type 2
    Estudio doble ciego, aleatorizado, multicéntrico, de grupos paralelos y controlado con placebo para evaluar el efecto de Kreon® sobre la insuficiencia pancreática exocrina en sujetos con diabetes mellitus tipo 2
    A.4.1Sponsor's protocol code numberM13-954
    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 SponsorAbbott Laboratories 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 supportAbbott Laboratories GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbott Healthcare Products BV
    B.5.2Functional name of contact pointGlobal Clinical Trial Management
    B.5.3 Address:
    B.5.3.1Street AddressC.J. van Houtenlaan 36
    B.5.3.2Town/ cityCP Weesp
    B.5.3.3Post code1381
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31294477367
    B.5.5Fax number31294410571
    B.5.6E-mailhanneke.vanassche@abbott.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 Kreon 25000
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories GmbH
    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 Capsule, hard
    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 INNnot assigned
    D.3.9.1CAS number 8049-47-6
    D.3.9.3Other descriptive namePANCREATIN
    D.3.9.4EV Substance CodeSUB12545MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25000
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Pancreatic exocrine insufficiency in diabetes type II
    Insuficiencia pancreática exocrina en diabetes tipo 2
    E.1.1.1Medical condition in easily understood language
    maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type II
    Mala digestion de macronutrients de la dieta (el páncreas no produce suficientes enzimas para la digestión de la grasa, azúcares y proteínas) en diabetes 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
    To evaluate the effect of Creon 25000 versus placebo on fat digestion as measured by the 13C Mixed Triglycerides Breath Test (MTBT) in patients with pancreatic exocrine insufficiency (PEI) and type 2 diabetes mellitus (DM).
    Evaluar el efecto sobre la digestión de grasas de Kreon 25000 frente a placebo evaluada por medio del test de aliento con 13C triglicéridos mixtos (MTBT, mixed triglycerides breath test) en pacientes con insuficiencia pancreática exocrina (PEI, pancreatic exocrine insufficiency) y diabetes mellitus (DM) de tipo 2.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    To assess the effect of Creon on nutritional parameters (fat soluble vitamins (D and E), retinol-binding protein, albumin, pre-albumin, magnesium, calcium), HbA1c, quality of life assessed via a questionnaire (Gastrointestinal-Quality of Life Index, GIQLI), Clinical Global Impression of Disease Symptoms, clinical symptomatology (stool frequency, stool consistency, abdominal pain, flatulence), and use of anti-diabetic medication.
    Safety and Tolerability Objectives:
    To evaluate the safety and tolerability of Creon in type 2 DM patients with PEI by collecting treatment-emergent adverse events (TEAE), vital signs (incl. body weight and BMI), physical examination and routine safety laboratory.
    Objetivos Secundarios:
    Evaluar el efecto de Kreon en parámetros nutricionales (vitaminas liposolubles [D y E], proteína transportadora de retinol, albúmina, pre-albúmina, magnesio y calcio), HbA1c, calidad de vida evaluada con el cuestionario GIQLI (Gastrointestinal Quality of Life Index), Impresión Clínica Global de los Síntomas de la Enfermedad, sintomatología clínica (frecuencia de las deposiciones, consistencia de las heces, dolor abdominal y flatulencia), y uso de medicación antidiabética.
    Objetivos de Seguridad y Tolerabilidad:
    Evaluar la seguridad y tolerabilidad de Kreon en pacientes con DM tipo 2 con PEI por medio de los acontecimientos adversos emergentes (TEAE, treatment emergent adverse events), constantes vitales (incluyendo el peso corporal y el índice de masa corporal [IMC]), exploración física y pruebas rutinarias de laboratorio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Signed Informed Consent
    ? BMI < 30 kg/m2
    ? History of type 2 diabetes mellitus as confirmed by:
    ? onset of diabetes after 30 years of age
    and
    ? no insulin treatment in the first year after diagnosis
    ? Subjects on insulin treatment or on insulin treatment in combination with oral antidiabetics
    ? HbA1c > 6.5% in medical history within the last 6 months despite insulin treatment
    ? Not previously treated with any pancreatic enzyme supplementation
    ? FE-1 <100?g/g of stool
    ? 13C MTBT of <29% 13CO2-CRR
    ? Consentimiento Informado Firmado.
    ? IMC < 30 kg/m2
    ? Historia de diabetes mellitus tipo 2 confirmada por:
    ? inicio de la diabetes diagnosticada después de los 30 años
    y
    ? sin tratamiento con insulina en el primer año tras el diagnóstico
    ? Sujetos en tratamiento con insulina o en tratamiento con insulina en combinación con antidiabéticos orales.
    ? HbA1c > 6.5% en la historia clínica dentro de los 6 últimos meses a pesar del tratamiento con insulina.
    ? No tratado previamente con un suplemento de enzima pancreático.
    ? FE-1 < 100?g/g de heces
    ? 13C MTBT <29% 13CO2-CRR
    E.4Principal exclusion criteria
    ? Treatment with systemic steroids for at least 3 weeks within past 6 months
    ? Patients with a known pancreatic exocrine insufficiency due to non-diabetic diseases, e.g., chronic pancreatitis, pancreatectomy, cystic fibrosis, celiac disease, shwachman-diamond syndrome, gastrectomy, etc.
    ? Known allergy to products of porcine origin
    ? Any type of malignancy involving digestive tract in the last 5 years
    ? Any type of gastrointestinal surgery (except appendectomy and gallbladder resection)
    ? Short bowel syndrome
    ? Hemochromatosis
    ? Any history of drug abuse including alcohol
    ? Positive urine pregnancy test; lactation; females of child-bearing potential who are not using either an oral hormonal contraceptive or an intrauterine device
    ? Severe allergy or any history of severe abnormal drug reaction
    ? Intake of an experimental drug within 4 weeks prior to entry into this study
    ? Suspected non-compliance or non-cooperation
    ? History of human immunodeficiency virus (HIV) infection
    ? Tratamiento con esteroides sistémicos durante al menos 3 semanas en los últimos 6 meses.
    ? Pacientes con una insuficiencia pancreática exocrina conocida debida a enfermedades no diabéticas, p. ej., pancreatitis crónica, pancreatectomía, fibrosis quística, enfermedad celiaca, síndrome de shwachman-diamond, gastrectomía, etc.
    ? Alergia conocida a los productos de origen porcino.
    ? Algún tipo de tumor maligno en el tracto digestivo en los últimos 5 años.
    ? Cirugía gastrointestinal (excepto apendicetomía y resección de la vesícula biliar).
    ? Síndrome del intestino corto.
    ? Hemocromatosis
    ? Historia de abuso de drogas incluyendo el alcohol.
    ? Prueba positiva de embarazo en orina; lactancia; mujeres en edad fértil que no usen anticonceptivo hormonal oral o un dispositivo intrauterino.
    ? Alergia severa o historia de reacción severa al fármaco.
    ? Ingesta de un fármaco experimental dentro de las 4 semanas previas a la entrada del estudio.
    ? Sospecha de no cumplimiento o no cooperación.
    ? Historia de infección del virus de inmunodeficiencia humana (VIH).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter will be the change from baseline to the end of the double-blind treatment in the 6-hour 13CO2?CRR as measured by the 13C MTBT.
    El parámetro principal de eficacia será el cambio desde basal al final del tratamiento doble ciego del 13CO2?CRR a las 6 horas calculado usando el 13C MTBT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline after 12 weeks of treatment
    Cambio desde basal después de 12 semanas de tratamiento
    E.5.2Secondary end point(s)
    ? nutritional parameters (fat soluble vitamins (D and E), retinol-binding protein, albumin, pre-albumin, magnesium and calcium),
    ? HbA1c,
    ? quality of life (QoL) assessed via a questionnaire (GIQLI),
    ? Clinical Global Impression (CGI) of Disease Symptoms,
    ? clinical symptomatology (stool frequency, stool consistency, abdominal pain, and flatulence),
    ? Use of anti-diabetic medication (insulin and, if applicable, oral anti-diabetic medication).
    The safety and tolerability data collected during this study are vital signs, height, weight and BMI, safety laboratory values and adverse events.
    ? Parámetros nutricionales: Niveles sanguíneos de vitaminas liposolubles (D y E), proteína transportadora de retinol, albúmina, pre-albúmina, magnesio y calcio),
    ? HbA1c,
    ? Calidad de vida (QoL) evaluada con el cuestionario GIQLI,
    ? Impresión Clínica Global de los Síntomas de la Enfermedad,
    ? Sintomatología clínica (frecuencia diaria de las deposiciones, consistencia de las heces, dolor abdominal y flatulencia)
    ? Utilización de medicación antidiabética (insulina y si procede, medicación oral antidiabética).
    Los datos de seguridad y tolerabilidad recogidos durante el estudio incluirán constantes vitales, altura, peso e IMC, valores de laboratorio de seguridad y acontecimientos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy parameters are evaluated by the change from baseline to 12 week of treatment. Safety parameters are assessed throughout the study.
    Los parámetros secundarios de eficacia se evalúan por medio de su cambio a las 12 semanas de tratamiento respecto a basal. Los parámetros de seguridad se evalúan a lo largo de todo el estudio.
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    LVLS
    Última visita del último paciente
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
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