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    Summary
    EudraCT Number:2014-002399-10
    Sponsor's Protocol Code Number:EFC13799
    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:2014-12-29
    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 number2014-002399-10
    A.3Full title of the trial
    A Randomized, Open-label, 2-arm Parallel-group, Multicenter, 26-week Study Assessing the Safety and Efficacy of H0E901-U300 Versus Lantus in Older Patients with Type 2 Diabetes Inadequately Controlled on Antidiabetic Regimens Either Including no Insulin, or with Basal Insulin as Their Only Insulin
    Estudio aleatorizado, abierto, con 2 grupos paralelos, multicéntrico y de 26 semanas de duración para evaluar la seguridad y eficacia de HOE901-U300 frente a Lantus en pacientes de edad avanzada con diabetes tipo 2 que están insuficientemente controlados con tratamientos antidiabéticos que no contienen insulina o que contienen insulina basal como única insulina.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the Safety and Efficacy of HOE901-U300 with Lantus in Older Patients with Type 2 Diabetes Insufficiently Controlled on their Current Antidiabetic Medications
    Comparación de la seguridad y la eficacia de HOE901-U300 con Lantus en pacientes de edad avanzada con diabetes tipo 2 que están insuficientemente controlados con sus tratamientos antidiabéticos actuales
    A.3.2Name or abbreviated title of the trial where available
    SENIOR
    SENIOR
    A.4.1Sponsor's protocol code numberEFC13799
    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 SponsorSanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    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 supportSanofi-aventis recherche & développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2, 5ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailES-unidadestudiosclinicos@sanofi.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 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 nameHOE901 - U300
    D.3.2Product code HOE901 - U300
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    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 GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.2Current sponsor codeHOE901 - U300
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland 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.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    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 GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.2Current sponsor codeHOE901
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    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) 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 Yes
    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
    Type 2 diabetes mellitus
    Diabetes Mellitus tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus
    Diabetes Mellitus tipo 2
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    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
    To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c)
    Demostrar la no inferioridad de HOE901-U300 en comparación con Lantus en la modificación de la hemoglobina glucosilada A1c (HbA1c) desde el momento basal hasta la Semana 26.
    E.2.2Secondary objectives of the trial
    To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:
    - Percentage of patients with at least one severe and/or confirmed (by plasma glucose ?70mg/dL [3.9mmol/L]) hypoglycemia event from 22:00 to 08:59 next morning
    - Percentage of patients with at least one nocturnal (from 00:00?05:59) severe and/or confirmed (?70mg/dL [3.9mmol/L]) hypoglycemia event
    - Percentage of patients with at least one severe and/or confirmed (by plasma glucose ?70mg/dL [3.9mmol/L]) hypoglycemia event occurring at any time of day
    - HbA1c change
    Demostrar la superioridad de HOE901-U300 en comparación con Lantus en:

    ? El porcentaje de pacientes con al menos un episodio de hipoglucemia
    severa y/o confirmada (mediante valores de glucosa plasmática 70
    mg/dl [3,9 mmol/l]) desde las 22:00 hasta las 08:59 de la mañana
    siguiente a lo largo de 26 semanas de tratamiento

    ? El porcentaje de pacientes con al menos un episodio de hipoglucemia
    nocturna (desde las 00:00 hasta las 05:59) severa y/o confirmada ( 70
    mg/dl [3,9 mmol/l]) a lo largo de 26 semanas de tratamiento

    ? El porcentaje de pacientes con al menos un episodio de hipoglucemia
    severa y/o confirmada (mediante valores de glucosa plasmática 70
    mg/dl [3,9 mmol/l]) ocurrido en cualquier momento del día, a lo largo de 26 semanas de tratamiento

    ? Cambio en la HbA1c desde el momento basal hasta la Semana 26
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients ?65 years old with type 2 diabetes mellitus, inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin.
    Signed informed consent.
    ? Pacientes sup o igual a 65 años con diabetes mellitus tipo 2, controlados insuficientemente con tratamientos farmacológicos antidiabéticos noinsulínicos o con insulina basal como única insulina y

    ? Consentimiento informado firmado
    E.4Principal exclusion criteria
    HbA1c at screening visit:
    - <7.0% or >10.0% for patients taking basal insulin.
    - <7.5% or >11.0% for insulin-naïve patients.
    History of type 2 diabetes mellitus for less than 1 year before screening.
    Patients not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit).
    Change in dose of antidiabetic treatment or initiation of new glucose-lowering medications in the last 8 weeks prior to screening.
    Chronic (>10 days continuous use in previous 6 months) use of bolus insulin injections, whether given separately or as part of a combination with basal insulin, eg, premix insulin; For insulin-naïve individuals: current or previous insulin use except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the last year prior to screening.
    Cognitive disorder and dementia assessed clinically and by Mini?Mental State Examination (MMSE) score <24, or any neurologic disorder that will likely affect the patient?s ability to follow the study procedure. The patient will be eligible despite an MMSE score <24 if the investigator determines that the low score reflects educational or cultural background and not dementia as long as the patient is otherwise able to meet the study requirements.
    Patients who have end-stage renal disease (<15 mL/min/1.73m^2, per estimated Glomerular filtration rate [eGFR] measurement by Modification of Diet in Renal Disease [MDRD]).
    ? HbA1c en la visita de selección:

    - < 7,0 % o > 10,0 % para pacientes que toman insulina basal,

    - < 7,5 % o > 11,0 % para pacientes no insulinizados

    ? Pacientes sin una dosis de insulina basal estable (± 10 % en las últimas 8 semanas antes de la visita de selección); cambio en la dosis del
    tratamiento antidiabético no-insulínico o inicio de nuevos fármacos
    hipoglucemiantes en las últimas 8 semanas antes de la selección;
    ? Uso crónico (> 10 días de uso continuo en los últimos 6 meses) de
    inyecciones de insulina en bolo, administradas por separado o como parte de una combinación con insulina basal, por ejemplo, insulina premezclada; en el caso de pacientes no insulinizados: uso actual o previo de insulina excepto durante un máximo de 10 días consecutivos (p. ej., enfermedad aguda, cirugía) durante el último año antes de la selección;

    ? Trastorno cognitivo y demencia evaluados clínicamente y por una
    puntuación < 24 en el Mini-Examen del Estado Mental (Mini-Mental State Examination, MMSE) o cualquier trastorno neurológico que probablemente afectará a la capacidad del paciente para seguir el procedimiento del estudio. El paciente será apto a pesar de tener una puntuación < 24 en el MMSE si el investigador determina que la baja puntuación refleja su bagaje educativo o cultural y no demencia, siempre que el paciente sea por lo demás capaz de cumplir los requisitos del estudio;
    ? Pacientes con enfermedad renal crónica terminal (< 15 ml/min/1,73 m2, conforme a la medición de la tasa de filtración glomerular estimada (TFGe) utilizando la fórmula de la Modificación de la Dieta en la Enfermedad Renal (Modification of Diet in Renal Disease, MDRD).
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c from baseline
    Variación de la HbA1c
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline, week 26
    desde el momento basal hasta la Semana 26.
    E.5.2Secondary end point(s)
    1 - Incidence (% of patients) of severe and/or confirmed (by plasma glucose ?70mg/dL [3.9mmol/L]) hypoglycemia event (symptomatic or asymptomatic) from 22:00 to 08:59 next morning over 26 weeks of treatment
    2 - Incidence (% of patients) of nocturnal (from 00:00 to 05:59) severe and/or confirmed (?70 mg/dL [3.9mmol/L]) hypoglycemia (symptomatic or asymptomatic) over 26 weeks of treatment
    3 - Incidence (% of patients) of severe and/or confirmed (by plasma glucose ?70mg/dL [3.9mmol/L]) hypoglycemia (symptomatic or asymptomatic), occurring at any time of day, over 26 weeks of treatment
    4 - Percentage of patients with HbA1c (a) <7.5% (b), <7.0%, at Week 26
    5 - Percentage of eligible patients with HbA1c (a) <7.5%, (b) <7.0%, at Week 26, with no severe and/or confirmed (by plasma glucose ?70mg/dL [3.9mmol/L]) hypoglycemia event over 26 weeks of treatment
    6 - Change in fasting plasma glucose (FPG) from baseline to Week 26
    7 - Change in Patient Report Outmcome (PRO) instruments scores from baseline to Week 26
    8 - Percentage of patients requiring rescue therapy over the 26 weeks of treatment
    1. Incidencia (% de pacientes) de episodios de hipoglucemia
    (sintomática o asintomática) severa y/o confirmada (mediante valores
    de glucosa plasmática 70 mg/dl [3,9 mmol/l]) desde las 22:00 hasta
    las 08:59 de la mañana siguiente a lo largo de 26 semanas de
    tratamiento.
    2. Incidencia (% de pacientes) de hipoglucemia nocturna (desde las
    00:00 hasta las 05:59) (sintomática o asintomática) severa y/o
    confirmada (mediante valores de glucosa plasmática 70 mg/dl [3,9
    mmol/l]) a lo largo de 26 semanas de tratamiento.
    3. Incidencia (% de pacientes) de hipoglucemia (sintomática o
    asintomática) severa y/o confirmada (mediante valores de
    glucosa plasmática 70 mg/dl [3,9 mmol/l]), ocurrida en
    cualquier momento del día, a lo largo de 26 semanas de
    tratamiento.
    4. Porcentaje de pacientes con HbA1c (a) < 7,5 % (b) < 7,0 %, en la
    Semana 26.
    5. Porcentaje de pacientes con HbA1c (a) < 7,5 % (b) < 7,0 %, en la
    Semana 26, sin episodios de hipoglucemia severa y/o confirmada
    (mediante valores de glucosa plasmática 70 mg/dl [3,9 mmol/l]) a lo
    largo de 26 semanas de tratamiento.
    6. Variación de la GPA desde el momento basal hasta la Semana 26.
    7. Cambio en las puntuaciones de RNP desde el momento basal hasta
    la Semana 26.
    8. Porcentaje de pacientes que requieren tratamiento de rescate a lo
    largo de 26 semanas de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - 2 - 3 - 4 - 5 - 8 - week 26

    6 - 7 - baseline, week 26
    1,2,3,4,5 y 8: a la semana 26
    6 y 7: desde el momento basal hasta la Semana 26.
    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 Yes
    E.6.12Pharmacoeconomic Yes
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Australia
    Brazil
    Canada
    Colombia
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Mexico
    Peru
    Poland
    Romania
    Spain
    Sweden
    United Kingdom
    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 years
    E.8.9.1In the Member State concerned months26
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months26
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 920
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Older patients
    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 293
    F.4.2.2In the whole clinical trial 920
    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)
    New formulation of insulin glargine has no marketing authorization yet and there is no medical need to provide study participants with new formulation of insulin glargine after study completion. Medical care after end of study will be continued by subjects' treating physicians (e.g. family practitioner) applying standard anti-diabetic treatments
    La nueva formulación de la insulina glargina no tiene autorización de comercialización todavía y no hay un vacío terapéutico demostrado como para proporcionar a los participantes la nueva formulación de la insulina glargina después de finalizar el ensayo. El seguimiento médico despúes de la finalización del ensayo será realizado por los médicos que tratan a los pacientes (como por ejemplo los médicos de familia) aplicando los tratamientos antidiabéticos estandards.
    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 Decision2015-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-20
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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