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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42570   clinical trials with a EudraCT protocol, of which   7009   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-002416-33
    Sponsor's Protocol Code Number:GLARGL07667
    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:2015-12-07
    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 number2015-002416-33
    A.3Full title of the trial
    An interventional, Open-label, single-arm, multicenter, 24 Weeks phase 4 study assessing the Efficacy and Safety of Toujeo in patients with Type 2 Diabetes inadequately controlled with Basal Insulin
    Etude de phase 4 interventionnelle, en ouvert, à un seul bras, multicentrique de 24 semaines évaluant l’efficacité et la tolérance de Toujeo chez des patients diabétiques de type 2 mal contrôlés par leur insuline basale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Toujeo insulin in type 2 diabetes patients inadequately control with their basal insulin treatment
    Evaluation de l'insuline Toujeo chez des patients diabétiques de type 2 ayant un diabète mal équilibré par leur insuline basale
    A.3.2Name or abbreviated title of the trial where available
    TRANSITION II
    A.4.1Sponsor's protocol code numberGLARGL07667
    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 France
    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 France
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis France
    B.5.2Functional name of contact pointDirection des Operations Cliniques
    B.5.3 Address:
    B.5.3.1Street Address82 avenue Raspail
    B.5.3.2Town/ cityGENTILLY
    B.5.3.3Post code94255 Cedex
    B.5.3.4CountryFrance
    B.5.4Telephone number0800 222 555
    B.5.6E-mailPublic-Registry-MA-France@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 GmbH
    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 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 mellitus
    Diabète de type 2
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus
    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 19.0
    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
    The primary objective is to describe the effect of HOE901-U300 in T2DM patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on HbA1c improvement.
    L’objectif principal de l’étude est de décrire l’effet de HOE901-U300 chez des patients diabétiques de type 2 mal contrôlés par leur insuline basale et éligibles à un changement d’insuline basale, selon le jugement de l’investigateur, en termes d’amélioration de l’HbA1c.
    E.2.2Secondary objectives of the trial
    - Evolution of fasting plasma glucose
    - Evolution of insulin dose and body weight
    - Hpoglycemia incidence
    - Safety
    - Patient’s satisfaction when they change their insulin for HOE901-U300
    - Reach of objective of insulin change, as defined by the investigator
    - Observance of insulin titration guidelines
    - Evolution de la glycémie à jeun
    - Evolution des doses d’insuline et du poids
    - Incidence des hypoglycémies
    - Tolérance
    - Satisfaction des patients lorsqu’ils changent leur insuline basale pour HOE901-U300
    - Atteinte de l’objectif de changement d’insuline défini par l’investigateur
    - Evaluation de l’observance vis-à-vis de l’algorithme de titration de l’insuline
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Types 2 diabetes adult patients treated with basal insulin, with or without oral anti-diabetic agents, with or without GLP1 receptor agonist
    - HbA1c > 7,5 %
    - Patients adultes diabétiques de type 2 traités par insuline basale, traités ou non par un antidiabétique oral ou un agoniste du récepteur du GLP1
    - HbA1c > 7,5 %
    E.4Principal exclusion criteria
    - Patients with high dose of insulin (>1,2 U/kg)
    - Use of prandial insulin
    - Change of dose of antidiabetic drugs within the last 8 weeks
    - Use of systemic glucocorticoids during at least 2 weeks in the last 12 weeks
    - Patients sous haute dose d’insuline basale (>1,2 U/kg)
    - Tout produit contenant de l’insuline prandiale
    - Changement de dose de traitement antidiabétique dans les 8 semaines précédentes
    - Utilisation de glucocorticoïdes systémiques pendant 2 semaines ou plus dans les 12 semaines avant la visite de sélection
    E.5 End points
    E.5.1Primary end point(s)
    Mean change of HbA1c
    Variation moyenne de l’HbA1c
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 24
    De la baseline à la semaine 24
    E.5.2Secondary end point(s)
    - Percentage of patients who reach fasting plasma glucose objective (90-130 mg/dL) at weeks 12 (J84) and 24 (J168)
    - Percentage of patients with HbA1c <7 %, <7,5 %, < 8 % at week 24
    - Mean change in HbA1c from baseline to week 12 and week 24 across subgroups of baseline HbA1c category (≤ 8%, >8 to 9%, >9 %)
    - Mean change in fasting plasma glucose from baseline to week 12 and week
    - Patient reported outcomes:
    - Mean change from baseline to week 24 regarding total satisfaction regarding treatment, perception of hypoglycemia and hyperglycemia, according to DTSQs questionnaire
    - DTSQc score at week 24
    - Reason of change of insulin as defined by the investigator
    - Percentage of patients who reach the objective defined by the investigator at screening (reason for change of insulin) at weeks 12 and 24
    - Percentage of patients with poor (< 50 %), moderate (50 à 75 %), good (> 75 %) observance to insulin titration guidelines Influence of the type of investigator’s practice on the care of the patient
    - Hypoglycemia
    - Adverse events, serious adverse events, technical complaints
    - Vital signs
    - Body weight
    - Basal insulin dose (dose of HOE901-U300 during the 24 weeks of treatment)
    - Pourcentage de patients qui atteignent l’objectif de glycémie à jeun (90-130 mg/dL) aux semaines 12 (J84) et 24 (J168)
    - Pourcentage de patients qui ont une diminution d’HbA1c d’au moins 0,3 % entre la baseline et la semaine 24 (J168)
    - Pourcentage de patients avec une HbA1c <7 %, <7,5 %, < 8 % à la semaine 24
    - Variation moyenne d’HbA1c entre la baseline et les semaines 12 et 24 selon les sous-groupes de catégories d’HbA1c à la baseline (≤ 8 %, >8 à 9 %, >9 %)
    - Variation moyenne de la glycémie à jeun entre la baseline et les semaines 12 et 24
    - Données rapportées par le patient :
    - Variation moyenne entre la baseline et la semaine 24 de la satisfaction totale au traitement, la perception des hyperglycémies et la perception des hypoglycémies d’après le questionnaire DTSQs
    - Score DTSQc à la semaine 24
    - Raison de changement d’insuline tel que défini par l’investigateur
    - Pourcentage de patients qui atteignent l’objectif défini par l’investigateur lors de la visite de sélection (raison du changement d’insuline) aux semaines 12 et 24
    - Pourcentage de patients ayant une observance faible (< 50 %), modérée (50 à 75 %) ou bonne (> 75 %) vis-à-vis de l’algorithme de titration de l’insuline
    - Influence du mode d’exercice de l’investigateur sur la prise en charge du patient
    - Hypoglycémies
    - Evènements indésirables (EI), Evènements indésirables graves (EIG), réclamations liées au produit
    - Signes vitaux
    - Poids
    - Dose d’insuline basale (dose de HOE901-U300 pendant les 24 semaines de traitement)
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12 and/or 24 according to the timepoint
    semaine 12 et/ou 24 selon le critère
    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.8.2.4Number of treatment arms in the trial1
    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 concerned115
    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 years
    E.8.9.1In the Member State concerned months20
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months20
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state350
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 350
    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
    Aucun
    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 Decision2015-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-24
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