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    Summary
    EudraCT Number:2015-004715-20
    Sponsor's Protocol Code Number:GLARGL07710
    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:2016-01-13
    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 number2015-004715-20
    A.3Full title of the trial
    Phase IV study to evaluate the safety and efficacy of the treatment of hyperglycemia with Gla-300 in basal-bolus regimen in hospitalised T2D patients poorly controlled with basal insulin and/or non-insulin treatments and therapy intensification at discharge with basal insulin .
    Estudio fase IV para evaluar la eficacia y seguridad de la nueva insulina glargina 300 U/ml (Gla-300) en régimen basal-bolos en pacientes con diabetes tipo 2 durante la hospitalización, y el efecto de la intensificación del tratamiento al alta con insulina basal.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the efficacy and safety of a basal insulin (Glargine 300) on glycemic control type 2 diabetic patients during hospitalization and at discharge.
    Estudio para evaluar la eficacia y seguridad de una insulina basal (Glargina 300) en el control glucémico de pacientes diabéticos tipo 2 durante la hospitalización y al alta.
    A.3.2Name or abbreviated title of the trial where available
    COBALTA
    COBALTA
    A.4.1Sponsor's protocol code numberGLARGL07710
    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, 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 supportSANOFI-AVENTIS S.A.
    B.4.2CountrySpain
    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, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number003493485 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 Yes
    D.2.1.1.1Trade name Toujeo
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland
    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 nameInsulin glargine
    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.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
    Diabetes tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes
    Diabetes 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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10049746
    E.1.2Term Insulin-requiring type II diabetes mellitus
    E.1.2System Organ Class 100000004861
    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 intensifying treatment at discharge with basal insulin strategy in hospitalised T2D patients poorly controlled with basal insulin and/or non-insulin treatments (HbA1c >=8.0 % on admission) measured by the decrease in HbA1c from discharge to month 6.
    Evaluar el efecto de la intensificación al alta con insulina basal en pacientes diabéticos tipo 2 hospitalizados y mal controlados con insulina basal y/o antidiabéticos no insulínicos (HbA1c >= 8.0% al ingreso) valorado por la reducción de la HbA1c a los 6 meses tras el alta.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy and safety of Gla-300 in basal-bolus regimen during hospitalization measured by in-patient blood glucose profile.
    To evaluate fasting plasma glucose at 3 and 6 months post-discharge.
    To evaluate the change in body weight from discharge to month 6.
    To evaluate patients' satisfaction with the study treatment.
    To know the incidence of confirmed or severe hypoglycemia during hospitalization and 6 months post-discharge.
    To study overall safety during hospitalization and 6 months post-discharge. All serious and non-serious adverse event and product technical complaints (device related) will be collected.
    To determine episodes of re-hospitalization or unexpected visits to the emergency room during 6 months post-discharge.
    Evaluar la eficacia de Gla-300 en pauta basal-bolos durante la hospitalización, mediante el perfil glucémico del paciente.
    Evaluar el cambio en la glucosa plasmática en ayunas a los 3 y 6 meses del alta hospitalaria.
    Evaluar el cambio en el peso corporal desde el alta hospitalaria hasta el mes 6.
    Evaluar el efecto de Gla-300 en la satisfacción del paciente con el tratamiento de la diabetes.
    Conocer la incidencia de hipoglucemia confirmada o severa durante la hospitalización y 6 meses tras el alta.
    Estudiar la seguridad durante la hospitalización y a los 6 meses tras el alta. Se recogerán todos los acontecimientos adversos (AAs) graves (AAGs) y no graves, así como los problemas técnicos relacionados con el dispositivo.
    Determinar el número de rehospitalizaciones o visitas no programadas a urgencias durante los 6 meses tras el alta.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects >18 and <75 years old.
    - Previous diagnosis of T2D.
    - Admitted to medical wards with a planned duration of hospitalization of at least 7 days in a haemodynamically stable situation (maximum of 2 weeks).
    - Treated with basal insulin and/or non-insulin treatments prior to admission.
    - Poorly controlled on admission: HbA1c between 8% and 10%.
    - Signed informed consent.
    - Pacientes de entre 18 y 75 años.
    - Pacientes con diabetes tipo 2.
    - Pacientes ingresados, con una duración planificada de hospitalización de al menos 7 días (máximo de 2 semanas) en situación hemodinámica estable.
    - Pacientes tratados antes del ingreso con insulina basal y/o antidiabéticos no insulínicos.
    - Pacientes deficientemente controlados al ingreso: valores de HbA1c 8%-10%.
    - Pacientes que firman el consentimiento informado para participar en el estudio.
    E.4Principal exclusion criteria
    - Type 1 Diabetes Mellitus.
    - Admission to hospital for decompensation of diabetes.
    - Any psychiatric or neurological disability preventing follow-up
    - Critical illness.
    - Previous treatment with premix or rapid acting insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week).
    - Glomerular filtration rate (GFR) < 30 ml/min measured by MDRD-4 equation.
    -Very high-risk patients who need mandatory insulin therapy at discharge (Treatment with corticoesteroids or pancreatic insufficiency (Pancreatitis / surgery).
    -Participation in any other study.
    - Pacientes con diabetes tipo 1.
    - Pacientes ingresados por descompensación de la diabetes.
    - Pacientes con alguna discapacidad psiquiátrica o neurológica que impida el seguimiento.
    - Pacientes en situación crítica.
    - Pacientes previamente tratados con premix o insulina de acción rápida (excepto tratamiento para la diabetes gestacional o tratamiento breve con insulina durante menos de 1 semana).
    - Pacientes con tasa de filtración glomerular (GFR) <30 ml/min por la fórmula MDRD-4.
    - Pacientes con riesgo muy elevado que necesitan tratamiento obligatorio con insulina de acción rápida al alta (tratamiento con corticosteroides o insuficiencia pancreática por pancreatitis o cirugía).
    - Pacientes que esté participando en otro estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in HbA1c from discharge to 6 months.
    Cambio medio en los niveles de HbA1c a los 6 meses tras el alta hospitalaria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From discharge to 6 months.
    Desde el alta hospitalaria hasta los 6 meses posteriores.
    E.5.2Secondary end point(s)
    Efficacy secondary end points:
    - % of hyperglycemia (>200 mg/dl), and glycemia exceeding objectives (Glycemia preprandial >130 and posprandial >180 mg/dl) of the four BG measurements per day during hospitalization and seven BG measurements at the beginning and end of hospitalisation (mg/dl).
    - Mean change in fasting plasma glucose during hospitalization and from discharge to month 3 and 6.
    - Body weight measurements at discharge and month 6.
    - Mean change in HbA1c from discharge to 6 months across patients with baseline HbA1c below or above 9%.

    Clinical status on discharge:
    - Hyperglycaemia-provoking factors
    - Contraindications and risk of hypoglycaemic agents
    - Insulin during hospital stay: basal, bolus and correction insulin doses in the 24 hours prior to discharge.

    Treatment on discharge:
    - Medication, dose and frequency at discharge and 6 months after discharge
    - Mean change in Gla-300 dose during hospitalization and from discharge to month 3 and 6.

    Satisfaction with treatment:
    Average DTSQ total treatment satisfaction, hyperglycemia perception and hypoglycaemia perception scores will be described at month 6..

    Safety:
    - Number and proportion of patients experiencing >= 1 episode of documented hypoglycaemia and number of documented and severe hypoglycaemic events per patient-year during hospitalization and between discharge and 6-month follow-up. Any hypglycaemic event at any time during day and night will be analyzed.
    (A Documented Hypoglycemic Episode is defined as an event during which typical symptoms of hypoglycemia or not are accompanied by a measured plasma glucose concentration < 70 mg/dl (3.9 mmol/l))
    - All serious and non-serious adverse event and product technical complaints (device related) will be collected.
    - Episodes of re-hospitalization or unexpected visits to hospital from discharge to month 6.
    Medidas secundarias de eficacia
    - Porcentaje de episodios de hiperglucemia (> 200 mg/dl), y de glucemia por encima de los valores objetivos (glucemia preprandial > 130 mg/dl y posprandial > 180 mg/dl) de 4 medidas diarias de glucemia capilar durante la hospitalización, y de 7 medidas al ingreso y en las últimas 24 horas previas al alta (realizadas antes y 2 horas después de empezar a comer en las tres comidas principales y al acostarse).
    - Medidas de glucosa plasmática en ayunas durante la hospitalización, y a los 3 y 6 meses tras el alta.
    - Medidas del peso corporal en el momento del alta y al mes 6.
    - Niveles de HbA1c a los 6 meses tras el alta entre los pacientes con HbA1c basal < 9% o > 9%.

    Medidas de la situación clínica al alta
    - Factores hiperglucemiantes
    - Contraindicaciones y riesgo de agentes hipoglucemiantes.
    - Insulina durante la hospitalización: dosis de insulina basal, en bolos o correctora en las 24 horas previas al alta.

    Medidas del tratamiento al alta:
    - Medicación, dosis y frecuencia al alta y a los 6 meses tras el alta.
    - Cambio medio en la dosis de Gla-300 durante la hospitalización y a los 3, 6 meses tras el alta.

    Medida de satisfacción con el tratamiento para la diabetes
    - Media en la puntuación total del cuestionario de satisfacción con el tratamiento de la diabetes (Diabetes treatment satisfaction questionnaire, DTSQ), incluyendo la frecuencia percibida de hiperglucemia (ítem 2 del DTSQ) y de hipoglucemia (ítem 3 del DTSQ) a los 6 meses del alta.

    Variables de seguridad
    - Número y porcentaje de pacientes que experimentan ?1 episodio de hipoglucemia confirmada* (sintomática o asintomática con glucemia <70 mg/dl (3.9 mmol/l) y severa, y número de episodios de hipoglucemia confirmada y severa por paciente/año (tasa anualizada) durante la hospitalización y entre el alta hospitalaria y los 6 meses de seguimiento. Se analizarán los episodios de hipoglucemia en cualquier momento del día (24hs) y durante la noche.
    *Hipoglucemia documentada sintomática o asintomática con glucemia <70 mg/dl (3.9 mmol/l). Hipoglucemia severa se define como un episodio de hipoglucemia que requiere asistencia de otra persona que administre hidratos de carbono, glucagón, o cualquier otra medida correctora.
    - Se recogerán todos los acontecimientos adversos graves (AAGs) y no graves (AAs), así como los problemas técnicos relacionados con el dispositivo.
    - Número de rehospitalizaciones o visitas a Urgencias durante los 6 meses tras el alta.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During hospitalization and between discharge and 6-month.
    Durante la hospitalización y desde el alta hasta el mes 6.
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned20
    E.8.5The trial involves multiple Member States No
    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 years
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state106
    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)
    Expected normal treatment.
    Práctica clínica habitual
    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 Decision2016-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-17
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