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    Summary
    EudraCT Number:2010-022337-29
    Sponsor's Protocol Code Number:NN1250-3846
    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:2010-12-20
    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 number2010-022337-29
    A.3Full title of the trial
    Ensayo para comparar la eficacia y la seguridad de insulina degludec una vez al día en pacientes con diabetes mellitus tipo 2 no tratados previamente con insulina cuando se utilizan dos algoritmos de ajuste de dosis diferentes.
    "A trial comparing the efficacy and safety of insulin degludec once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different titration algorithms"
    A.3.2Name or abbreviated title of the trial where available
    BEGIN: ONCE SIMPLE USE
    A.4.1Sponsor's protocol code numberNN1250-3846
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 nameNN1250
    D.3.2Product code NN1250
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNinsulin degludec
    D.3.9.2Current sponsor codeNNC 0100-000-0454
    D.3.10 Strength
    D.3.10.1Concentration unit EID50/dose 50% Embryo Infective Dose/dose
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Diabetes mellitus tipo 2.
    "Type 2 diabetes mellitus".
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Confirmar la eficacia del algoritmo sencillo de ajuste de la dosis de insulina degludec 100 U/ml (IDeg) una vez al día (OD) + metformina para controlar la glucemia en cuanto a la variación de la hemoglobina glucosilada (HbA1c) desde el momento basal hasta después de 26 semanas de tratamiento. Se realizará comparando la diferencia en la variación de la HbA1c desde el momento basal hasta después de 26 semanas de tratamiento obtenida con IDeg una vez al día utilizando el algoritmo sencillo + metformina y con IDeg una vez al día utilizando el algoritmo escalonado + metformina, hasta un límite de no inferioridad del 0,4%.
    "To confirm the efficacy of the insulin degludec 100 U/mL (IDeg) once daily (OD) simple titration algorithm + metformin in controlling glycaemia with respect to change from baseline glycosylated haemoglobin (HbA1c) after 26 weeks of treatment".
    E.2.2Secondary objectives of the trial
    Comparar la eficacia y la seguridad de dos algoritmos de ajuste de dosis diferentes tras 26 semanas de tratamiento en cuanto a:
    - Otros parámetros de control de la glucemia
    - Seguridad
    Describir la satisfacción del paciente con la pluma en investigación PDS290.
    "To compare the efficacy and safety of the two different titration algorithms after 26 weeks of treatment in terms of:
    - Other parameters for glycaemic control
    - Safety
    To describe subject satisfaction with the investigational pen PDS290".
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Varones y mujeres con edad mayor o igual a 18 años.
    - Diabetes tipo 2 (diagnosticada clínicamente) durante al menos 24 semanas antes de la aleatorización (visita 2).
    - Pacientes sin exposición previa a insulina (se permite: tratamiento breve previo con insulina, de hasta 14 días como máximo; se permitirá el tratamiento durante períodos mayores de 14 días en total en caso de hospitalización o diabetes gestacional).
    - Tratamiento actual: metformina en monoterapia o metformina en cualquier combinación con 1 ó 2 ADO distintos, incluyendo secretagogos de la insulina (sulfonilurea o glinida), inhibidores de la dipeptidil peptidasa IV (DPP-IV), inhibidores de la alpha-glucosidasa o tiazolidinedionas (TZD), todos ellos sin modificación de la dosis en las 12 semanas previas a la aleatorización (visita 2).
    - Metformina: sola o en combinación (incluida una combinación fija) en dosis de 1.000 mg/día como mínimo.
    -HbA1c del 7,0% al 10,0% (ambos inclusive) en el análisis del laboratorio central.
    -Capacidad y disposición de cumplir con el protocolo, incluida la medición de la glucemia por el paciente, según el protocolo.
    "- Male and female higher or equal to 18 years.
    - Type 2 diabetes (diagnosed clinically) for equal or more than 24 weeks prior to randomisation (Visit 2).
    - Insulin naïve subjects (Allowed are: Previous short term insulin treatment less or equal to 14 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods > 14 days in total).
    - Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2).
    - metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
    - HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
    - Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol".
    E.4Principal exclusion criteria
    - Tratamiento con un agonista del receptor del péptido similar al glucagón-1 (GLP-1) en las 12 semanas previas a la visita 2.
    - Hipoglucemia severa recurrente (más de un episodio de hipoglucemia severa en los últimos 12 meses) o falta de conciencia de la hipoglucemia, según el criterio del investigador
    - Participación previa en este ensayo. La participación se define por el hecho de haber sido aleatorizado. Se podrá repetir la selección en una ocasión durante el período de selección.
    - Hipersensibilidad confirmada o sospechada a los productos del ensayo o a productos afines.
    - Tratamiento con cualquier fármaco en investigación en las 4 semanas previas a la visita 2.
    "- Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2.
    - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator.
    - Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period.
    - Known or suspected hypersensitivity to trial products or related products
    - The receipt of any investigational drug within 4 weeks prior to Visit 2."
    E.5 End points
    E.5.1Primary end point(s)
    La variación de la HbA1c (%) con respecto al período basal tras 26 semanas de tratamiento (analizado por el laboratorio central).
    "Change from baseline in HbA1c (%) after 26 weeks of treatment (analysed by central laboratory)."
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Dos algoritmos de autoajuste. "Two self-titration algorithms".
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    UVUP: Última Visita del Último Paciente.
    "LSLV: Last Subject Last Visit".
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-12-20. Yes
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 158
    F.4.2.2In the whole clinical trial 336
    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)
    N/A
    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 Decision2011-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-20
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