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    Summary
    EudraCT Number:2010-020460-38
    Sponsor's Protocol Code Number:CLAF237AFR03
    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:2010-07-06
    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 ConcernedFrance - ANSM
    A.2EudraCT number2010-020460-38
    A.3Full title of the trial
    Etude prospective, randomisée, en ouvert évaluant le bénéfice clinique sur les hypoglycémies après 6 mois de l’addition de la vildagliptine versus celle d’un autre antidiabétique oral, chez des patients âgés diabétiques de type 2, insuffisamment contrôlés par la metformine en monothérapie.
    A.3.2Name or abbreviated title of the trial where available
    GLYCEMIA
    A.4.1Sponsor's protocol code numberCLAF237AFR03
    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 SponsorNovartis Pharma S.A.S
    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 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 Yes
    D.2.1.1.1Trade name GALVUS
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    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 namevildagliptin
    D.3.2Product code LAF237A
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNvildagliptin
    D.3.9.2Current sponsor codeLAF237A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Diabète de type II
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10012601
    E.1.2Term 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
    L’objectif principal est de comparer dans les deux groupes de traitement, le pourcentage de patients n’ayant présenté aucune hypoglycémie (épisodes confirmés par automesure de la glycémie capillaire ou hypoglycémie sévère) sur les 6 mois de suivi de l’étude.
    E.2.2Secondary objectives of the trial
    Décrire et comparer dans les 2 groupes de traitement :
    • le pourcentage de patients atteignant leur objectif thérapeutique d’HbA1c (≤ 6.5% ou ≤7% si prédéfini comme tel pour les patients dont l’objectif a été individualisé)
    • l’atteinte du critère primaire (absence d’hypoglycémie confirmée/sévère) dans le sous-groupe des patients ayant atteint leur objectif thérapeutique d’HbA1c
    • le pourcentage de patients atteignant leur objectif thérapeutique d’HbA1c dans le sous-groupe des patients qui ont atteint le critère primaire (patients sans hypoglycémie confirmée/sévère) et dans le sous-groupe n’ayant pas atteint ce critère primaire
    • l’évolution du contrôle glycémique: réduction de l’HbA1c par rapport à la valeur initiale; réduction de la moyenne des 6 points d’ASG par rapport à la valeur moyenne initiale
    Voir autres objectifs secondaires dans le protocole pages 13-14.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Hommes et femmes diabétiques de type 2 traités par metformine depuis au moins 3 mois, à leur dose maximale tolérée lors de la visite de sélection (semaine - 2).
    • Age > 65 ans et ≤ 80 ans.
    • Indice de masse corporelle (IMC) de 22-45 kg/m2 inclus lors de la visite 1.
    • Taux d'HbA1c > 6,5 ou > 7% selon leur objectif individualisé (les patients pour lesquels l’objectif individualisé est une HbA1c ≤ 7%, doivent être inclus si HbA1c > 7%), et HbA1c ≤ 8,5% lors de la visite 1.
    • Glycémie à jeun <15 mmol/l lors de la visite 1.
    • Obtention du consentement éclairé écrit pour participer à l'étude.
    • Capacité à respecter toutes les exigences de l'étude.
    • Etre affilié(e) à un régime de Sécurité Sociale ou bénéficiaire d’un tel régime.
    E.4Principal exclusion criteria
    • Les états physiologiques et pathologiques concomitants suivants constitueront des critères de non inclusion :
    • Antécédent de Diabète de type 1, de toutes formes secondaires de DT2, et de complications métaboliques aigues du diabète dans les 6 derniers mois (telles qu'acidocétose ou état hyperosmolaire)
    • Infections aiguës susceptibles d'affecter le contrôle glycémique au cours des 4 semaines précédant la visite 1.
    • Corticothérapie chronique orale ou parentérale (> 7 jours consécutifs de traitement) au cours des 8 semaines précédant la visite 1.
    • Antécédent de complications cardiovasculaires graves (torsades de pointe, tachycardie ventriculaire ou fibrillation ventriculaire, intervention coronaire percutanée au cours des 3 derniers mois, ou infarctus du myocarde, pontage coronarien, angor instable ou accident vasculaire cérébral au cours des 6 derniers mois); d’insuffisance cardiaque sévère (grade III/IV NYHA)
    • Insuffisance hépatique.
    • Une des anomalies biologiques suivantes lors de la visite 1: ALAT, ASAT > 3 fois LSN, clairance de la créatinine < 50 ml/min (calculée par la formule de Cockroft),
    • Dysthyroidie non corrigée sous traitement lors de la visite de sélection (un patient équilibré sous traitement substitutif stable par hormones thyroidiennes par exemple, peut être inclus).
    • Patients potentiellement peu fiables, et ceux que l'investigateur estime ne pas convenir à l'étude (notamment si impossibilité de réaliser l’autosurveillance glycémique); et traitement par un médicament en essai clinique au cours des 4 semaines précédant la visite 1.
    • Contre-indications et précautions d'emploi de la metformine utilisée comme traitement de fond, conformément au RCP français et non précisées par les autres critères d'exclusion.
    • Hypersensibilité à la vildagliptine ou à l'un des excipients du médicament conformément au RCP actuel de Galvus®.
    E.5 End points
    E.5.1Primary end point(s)
    Le critère principal est le pourcentage de patients sans hypoglycémie (épisodes confirmés par automesure de la glycémie capillaire ou hypoglycémie sévère) au cours des 6 mois de suivi de l’étude.
    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 Yes
    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) 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 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.8.3 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 concerned202
    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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months3
    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 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) No
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    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 Decision2010-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
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