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    Summary
    EudraCT Number:2014-000969-47
    Sponsor's Protocol Code Number:13702908
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-22
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-000969-47
    A.3Full title of the trial
    Clinical efficacy of coordinated boluses in type 1 diabetic patients treated with insulin pumps: a multicentric, randomised, cross over study (COBOL study).
    Evaluation de l’efficacité clinique des bolus coordonnés chez des diabétiques de type 1 traités par pompe externe : étude randomisée, croisée, multicentrique.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of coordinated bolus in type 1 diabetic patients treated with insulin pumps.
    Efficacité des bolus coordonnés chez les patients présentant un diabète de type 1 traités par une pompe à insuline
    A.3.2Name or abbreviated title of the trial where available
    COBOL
    COBOL
    A.4.1Sponsor's protocol code number13702908
    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 SponsorUniversity Hospital of Toulouse
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistry of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHu Toulouse
    B.5.2Functional name of contact pointDirection de la Recherche
    B.5.3 Address:
    B.5.3.1Street AddressHôtel-Dieu - Saint Jacques, 2 rue viguerie, TSA80035
    B.5.3.2Town/ cityToulouse
    B.5.3.3Post code31059
    B.5.3.4CountryFrance
    B.5.4Telephone number0561778347+33
    B.5.5Fax number0561778411+33
    B.5.6E-mailgascon.s@chu-toulouse.fr
    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 APIDRA
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 Yes
    D.3.11.13.1Other medicinal product typeInsuline glulisine produite par la technique de l'ADN recombinant dans Escherichia coli.
    D.IMP: 2
    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 HUMALOG
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 Yes
    D.3.11.13.1Other medicinal product typeADN d'origine recombinante, produite par Escherichia coli.
    D.IMP: 3
    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 NOVORAPID
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 Yes
    D.3.11.13.1Other medicinal product typeInsuline asparte produite par ADN recombinant sur Saccharomyces cerevisiae
    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 1 diabetic patients
    Patients présentant un diabète de type 1
    E.1.1.1Medical condition in easily understood language
    type 1 diabetic patients
    Patients présentant un diabète de type
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 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 compare the efficacy of coordinated boluses versus normal boluses on postprandial glycaemic control of T1D patients treated with continuous subcutaneous insulin infusion.
    Comparer, chez des patients diabétiques de type 1 traités par pompe à insuline et pratiquant l’insulinothérapie fonctionnelle, l’efficacité des bolus coordonnés par rapport aux bolus habituels sur l’équilibre glycémique postprandial, évalué à partir de la moyenne des glycémies capillaires mesurées 2 heures après les repas.
    E.2.2Secondary objectives of the trial
    - to compare efficacy and safety of coordinated boluses with normal boluses on total and postprandial glycaemic control of patients. this will be evaluate using clinical, biological parameters and capillary glyceamia and glucose continue mesurement
    - to bring better comprehension on coordinated boluses action's mechanism
    Comparer l’efficacité et la sécurité d’utilisation des bolus coordonnés par rapport aux bolus habituels sur l’équilibre glycémique global et postprandial des patients, évalué à partir d’indicateurs cliniques, biologiques, des mesures de la glycémie capillaire et de systèmes de mesure continue du glucose.
    Apporter des éléments de compréhension des mécanismes d’action des bolus coordonnés.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Type 1 diabetes mellitus
    - with confirmed Negative C-peptide or diabetes duration>5 years
    - Treated by external insulin pump Medtronic Paradigm Real-Time or VEO and rapid insulin analog
    - Educated to and practicing functional insulin treatment and carbohydrate counting
    - Able to use the “basal temp” and “glycaemia reminder” functions of their pump
    - Basal infusion rate ≥ 0.5U/h
    - SMBG frequency > 4/days
    - Aware of hypoglycaemia
    - Diabétiques de type 1.
    - Dont le C-peptide est négatif de façon documentée ou dont le diabète évolue depuis plus 5 ans.
    - Traités par pompe externe et analogue rapide de l’insuline depuis plus de 3 mois.
    - Utilisant une pompe de modèle Medtronic Paradigm Real-Time ou VEO.
    - Formés à l’insulinothérapie fonctionnelle et pratiquant celle-ci pour l’ajustement des doses de bolus prandial depuis plus de 3 mois.
    - Aptes à utiliser les fonctions « débit de base temporaire » et « rappel glycémie ».
    - Ayant un débit de base ≥ 0,5 U/h.
    - Habitués à la tenue d’un carnet d’ASG.
    - Se surveillant plus de 4 fois/j, attesté par un nombre de contrôles glycémiques > 56 au cours des 14 derniers jours d’après la mémoire de leur lecteur de glycémie.
    - Percevant les hypoglycémies.
    - Faisant 3 repas par jour sans collation, espacés d’au moins 3 heures.
    - Affiliés à un régime de sécurité sociale.
    - Signature du consentement éclairé.
    E.4Principal exclusion criteria
    - impaired renal function (creatinin clearance <60ml/min)
    - Gastroparesis
    - Serious or instable disease likely to induce a glycaemic control deterioration
    - treatment with corticosteroids
    Insuffisance rénale connue (clairance de la créatinine <60 ml/min).
    - Gastroparésie connue ou suspectée (prise de prokinétiques type Motilium, administration courante de bolus carrés ou combinés pour des repas habituels).
    - Pathologie grave récente ou non stabilisée pouvant entraîner une variation de l’équilibre glycémique durant l’étude, au jugement de l’investigateur.
    - Corticothérapie (hors collyres et sprays) en cours ou prévue durant la durée de l’étude.
    - Participation à une autre étude clinique.
    - Allergie connue au dispositif de mesure continue du glucose utilisé dans l’étude.
    - Patient sous tutelle, curatelle ou sauvegarde de justice.
    - Grossesse et/ou allaitement.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the mean of 2 hours postprandial glycaemia measured by SMBG.
    Le critère principal de jugement de cette étude est la moyenne des glycémies postprandiales mesurées par autosurveillance glycémique 2H après les prises alimentaires.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 hours postprandial
    2H après les prises alimentaires.
    E.5.2Secondary end point(s)
    - Clinical parameters : adverse events, severe hypoglycaemia frequency, insulin doses (basal rate and boluses)
    - Data from SMBG : mean glyceamia, standard deviation, frequency of glycaemia ≤60mg/dl, between 61-140mg/dl, and >140mg/dl
    - Data from CGM : mean glucose level, standard deviation, time spent within glucose ranges: ≤60mg/dl, between 61-140mg/dl, and >140mg/dl
    - Biological parameter: fructosamine
    Données cliniques :
    - recueil des EI et EIG durant l’étude.
    - hypoglycémies sévères (hypoglycémies nécessitant l’aide d’un tierce personne, avec ou sans coma).
    - doses d’insuline de bolus et de débit de base.
    Données des glycémies capillaires :
    - moyenne, écart-type, fréquence des hypoglycémies (≤60mg/l), % valeurs dans la zone de normoglycémie (61-140mg/dl) ou d’hyperglycémie (>140mg/dl) sur les périodes postprandiales et sur l’ensemble de la journée.
    Données de la mesure continue du glucose :
    - niveau glycémique moyen, écart-type et temps passé en hypoglycémie (≤60mg/l) , en normoglycémie (61-140mg/dl) ou en hyperglycémie (>140mg/dl) sur les périodes postprandiales et sur l’ensemble de la journée
    Paramètre biologique :
    - Fructosamine
    E.5.2.1Timepoint(s) of evaluation of this end point
    during postprandials periods and during the day.
    sur les périodes postprandiales et sur l’ensemble de la journée.
    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 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 No
    E.8.1.6Cross over Yes
    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
    une autre méthode d'administration
    an other method of administration
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Dernière visite du dernier patient
    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 months
    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: 21
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 state21
    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)
    No plans needed. Patients will be treated with normal bolus.
    Aucune modalité de prise en charge particulière des patients n’est prévue, les patients reprendront simplement la méthode de calcul classique des bolus.
    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 Decision2014-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-29
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