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    Summary
    EudraCT Number:2015-005034-21
    Sponsor's Protocol Code Number:VERGES-AZ-2015
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-12-03
    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 number2015-005034-21
    A.3Full title of the trial
    Effets de la Dapagliflozine sur la cinétique des lipoprotéines chez des patients diabétiques de type 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effets de la Dapagliflozine sur les modifications des lipides chez des patients diabétiques de type 2
    A.3.2Name or abbreviated title of the trial where available
    Cinétique DAPA
    A.4.1Sponsor's protocol code numberVERGES-AZ-2015
    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 SponsorCHU de DIJON
    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 supportAstrazeneca
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de DIJON
    B.5.2Functional name of contact pointChef de projets recherche
    B.5.3 Address:
    B.5.3.1Street AddressDRCI - 14 rue Paul Gaffarel
    B.5.3.2Town/ cityDijon
    B.5.3.3Post code21079
    B.5.3.4CountryFrance
    B.5.6E-mailmaud.carpentier@chu-dijon.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 Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameForxiga
    D.3.2Product code Dapagliflozine
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboFilm-coated tablet
    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
    diabète de type 2
    E.1.1.1Medical condition in easily understood language
    diabète de type 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 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
    Evaluer les effets de 10 mg/j de Dapagliflozine chez les patients diabétiques de type 2, sur:
    - les taux de production de l’Apo B des VLDL1, de l’Apo B, de l’Apo B des VLDL2, de l’Apo B des IDL et de l’Apo B des LDL, des Esters de Cholestérol des VLDL1, des EC des VLDL2, des EC des IDL et des EC des LDL, de l’Apo A1 du HDL et des EC du HDL.
    - le Fractional Catabolic Rate de l’Apo B des VLDL1, du Fractional Catabolic Rate de l’Apo B, du Fractional Catabolic Rate de l’Apo B des VLDL2, du Fractional Catabolic Rate de l’Apo B des IDL et du Fractional Catabolic Rate de l’Apo B des LDL, du Fractional Catabolic Rate des Esters de Cholestérol (EC) des VLDL1, du Fractional Catabolic Rate des EC des VLDL2, du Fractional Catabolic Rate des EC des IDL et du Fractional Catabolic Rate des EC des LDL, du Fractional Catabolic Rate de l’Apo A1 du HDL et du Fractional Catabolic Rate des EC du HDL.
    E.2.2Secondary objectives of the trial
    Analyser les effets de 10 mg/j de Dapagliflozine sur les pools plasmatiques de l’Apo B des VLDL1, de l’Apo B des VLDL2, de l’Apo B des IDL, de l’Apo B des LDL des Esters de Cholestérol des VLDL1, des EC des VLDL2, des EC des IDL et des EC des LDL, de l’Apo A1 et des EC du HDL.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - personne ayant donné son consentement écrit
    - Diabète de type 2 traités par ADO en monothérapie (metformine ou sulfonylurés ou glinides ou acarbose ou inhibiteurs DPPIV)
    - Traitement stable depuis 3 mois
    - HbA1c entre 7,5% et 10%
    - Age entre 30 et 65 ans
    - BMI entre 25 et 35 kg/m²
    - Triglycérides < 300 mg/dl
    - La moitié des patients sont traités par statines
    - eGFR > 75 ml/min/1,73 m² à l’inclusion
    E.4Principal exclusion criteria
    - personne non affiliée à un régime de sécurité sociale
    - patients traités par plus d’un traitement antidiabétique
    - patient traité par Insuline ou agoniste GLP-1
    - Patient sous tutelle, curatelle, sauvegarde de justice
    - patients traités par hypolipémiants (sauf statines pour 50 % des patients)
    - Insuffisance rénale
    - insuffisance hépatique ou fonction hépatique anormale avec des ASAT ou ALAT >3 x la limite normale supérieure
    - bilirubine totale >2mg/dl
    - maladies intestinales
    - preuves sérologiques de la présence d’une infection hépatique active (antigène de surface hépatite B, anticorps hépatite C, anticorps IgM hépatite B)
    - Grossesse, allaitement
    - hypersensibilité à la substance active ou aux excipients
    - patients présentant une déplétion volémique, par exemple en raison d’une maladie aigüe (telle qu’une maladie gastro-intestinale)
    - patients traités par diurétique de l’anse ou thiazidique
    E.5 End points
    E.5.1Primary end point(s)
    Les taux de production de l'Apo B des VLDL1, de l'Apo B des VLDL2, de l'Apo B des IDL, de l'Apo B des LDL et de l'Apo A1 des HDL.
    Le Fractional Catabolic Rate de l'Apo B des VLDL1, le Fractional Catabolic Rate de l'Apo B des VLDL2, le Fractional Catabolic Rate de l'Apo B des IDL, le Fractional Catabolic Rate de l'Apo B des LDL et le Fractional Catabolic Rate de l'Apo A1 des HDL.
    E.5.1.1Timepoint(s) of evaluation of this end point
    après 6 mois de traitement
    E.5.2Secondary end point(s)
    les pools plasmatiques de l’Apo B des VLDL1, de l’Apo B des VLDL2, de l’Apo B des IDL, de l'Apo B des LDL et de l'apoA1 des HDL avant et après 26 semaines de traitement par 10 mg/j de Dapagliflozine
    E.5.2.1Timepoint(s) of evaluation of this end point
    Après 6 mois de traitement
    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 No
    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 concerned2
    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
    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 months30
    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: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 No
    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 state26
    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
    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 Decision2016-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-06
    P. End of Trial
    P.End of Trial StatusOngoing
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