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    Summary
    EudraCT Number:2012-001208-39
    Sponsor's Protocol Code Number:GALILEO242012
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-04-17
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-001208-39
    A.3Full title of the trial
    A new therapeutic approach to prevent acute insulin-mediated complications in type 2 diabetes
    Subtitle: The effect of the combination of the GLP-1 Analog Liraglutide and Insulin LEvemir® vs. cOnventional insulin therapy: GALILEO
    Neuer Therapieansatz zur Verhinderung akuter Komplikationen bei Typ 2 Diabetes: Der Effekteiner Kombination des GLP-1 Analogons Liraglutide mit Insulin Levemir® im Vergleich zur konventionellen Insulintherapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A new therapeutic approach to prevent acute complications in type 2 diabetes: The effect of the combination of the GLP-1 Analog Liraglutide and Insulin LEvemir® against the cOnventional insulin therapy: GALILEO
    Neuer Therapieansatz zur Verhinderung akuter Komplikationen bei Typ 2 Diabetes: Der Effekt einer Kombination des GLP-1 Analogons Liraglutide mit Insulin LEvemir im Vergleich zur kOnventionellen Insulintherapie: GALILEO
    A.3.2Name or abbreviated title of the trial where available
    GALILEO
    GALILEO
    A.4.1Sponsor's protocol code numberGALILEO242012
    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 SponsorMedizinische Universität Wien, Univ.Klinik für Innere Medizin III, Abt.f.Endokrinologie und Stoffwechsel
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Wien
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Wien, Univ.Klinik für Innere Medizin III
    B.5.2Functional name of contact pointAbt.f.Endokrinologie&Stoffwechsel
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number00431404004311
    B.5.5Fax number00431404004309
    B.5.6E-mailyvonne.winhofer@meduniwien.ac.at
    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.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Levemir
    D.3.2Product code EMEA/H/C/000528
    D.3.4Pharmaceutical form Injection
    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 DETEMIR
    D.3.9.1CAS number 169148-63-4
    D.3.9.4EV Substance CodeSUB02692MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameVictoza
    D.3.2Product code EMEA/H/C/001026
    D.3.4Pharmaceutical form Injection
    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 INNLIRAGLUTIDE
    D.3.9.1CAS number 204656-20-2
    D.3.9.4EV Substance CodeSUB25238
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationAustria
    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 aspart
    D.3.2Product code EMEA/H/C/000308
    D.3.4Pharmaceutical form Injection
    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 ASPART
    D.3.9.1CAS number 116094-23-6
    D.3.9.4EV Substance CodeSUB08195MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    diabetes mellitus type 2, inadequate metabolic control, indication for insulin therapy
    myocardial lipid accumulation and left-ventricular function, retinal changes, microabluminuria, beta-cell-function, endothelial dysfunction
    Diabetes mellitus Typ 2,unzureichende Stoffwechselkontrolle, Indikation für Insulintherapie
    Myokardiale Lipidakkumualtion und Herzfunktion, retinale Veränderungen, Mikroalbuminurie, Beta-Zell-Funktion, Ednotheliale Dysfunktion
    E.1.1.1Medical condition in easily understood language
    Typ 2 Diabetes, bad metabolic control, need for insulin therapy
    acute secondary diabetes-related complications
    Typ 2 Diabetes, schlechte Stoffwechseleinstellung, insulinpflichtig
    akute Folgeerkrankungen
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10012607
    E.1.2Term Diabetes mellitus inadequate control
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10012689
    E.1.2Term Diabetic retinopathy
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10012654
    E.1.2Term Diabetic complications cardiovascular
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10012647
    E.1.2Term Diabetic cardiomyopathy
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10012658
    E.1.2Term Diabetic complications renal
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10012657
    E.1.2Term Diabetic complications ophthalmic
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10054044
    E.1.2Term Diabetic microangiopathy
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10012653
    E.1.2Term Diabetic complications
    E.1.2System Organ Class 10014698 - Endocrine 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 aim of the current study is to evaluate the acute effects of gradual, insulin sparing (GLP-1-based therapy) versus acute (insulin-based therapy) glucose lowering on myocardial lipid content (assessed by MR-spectroscopy) in patients with type 2 diabetes.
    Ziel dieser Studie ist festzustellen, ob eine alternative Insulin-sparende GLP-1 basierte Therapie im Gegensatz zu einer konventionellen Insulintherapie eine akute Zunahme des myokardialen Lipidgehaltes ("Herzverfettung") verhindern kann.
    E.2.2Secondary objectives of the trial
    Changes in
    • hepato-cellular lipid content
    • left ventricular function (ejection fraction, end-systolic volume, end-diastolic volume, stroke volume, cardiac output, mass, wall thickness, E/A-ratio) and remodeling-indices
    • retinal morphology, perfusion and function as measured by Optical Coherence Tomography (SD-OCT) and fluorescein angiography
    • retinal function measured by microperimetry
    • biomarkers of endothelial dysfunction
    • microalbuminuria
    • beta-cell-function
    Veränderungen
    • des hepatozellulären Lipidgehaltes
    • der linksventrikulären Funktion (Auswurffraktion, end-systolisches und end-diastolisches Volumen, Herz-Minuten-Volumen, myokardiale Wanddicke und Remodelling-Indixes
    • des Augenhintergrunds (Perfusion und Funktion, vaskuläre Veränderungen)
    • Biomarker der endothelialen Dysfunktion
    • Microalbuminurie
    • beta-cell-function
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Type 2 diabetes
    • Currently under oral glucose lowering medication
    • Insufficient metabolic control: HbA1C > 8%
    • Patient understands study procedure and gives written informed consent
    - Diabetes mellitus Typ 2
    - dzt.orale antidiabetische Therapie
    - Unzureichende Stoffwechseleinstellung: HbA1C > 8%
    - PatientIn versteht die studienbezogenen Maßnahmen und gibt sein/ihr schriftliches Einverständnis
    E.4Principal exclusion criteria
    • Age < 18 years
    • Type 1 Diabetes, LADA-Diabetes
    • Prior insulin administration/therapy
    • Therapy with thiazolidiones
    • Known cardiovascular disease (history of myocardial infarction, stroke etc)
    • Severe arterial hypertension
    • Acute or chronic inflammatory disease within 2 weeks prior the study
    • Kidney or liver disease
    • Psychiatric disorder
    • Tendency towards claustrophobia
    • metal devices or other magnetic material in or on the subjects body which will be hazardous for NMR investigation
    • Alter < 18 Jahre
    • Typ 1 Diabetes, LADA-Diabetes
    • Frühere Insulin Administration/Therapie
    • Therapie mit Thiazolidionen (Pioglitazon)
    • Bekannte koronare Herzkrankheit (Z.n.Herzinfarkt oder Schlaganfall)
    • Schwere arterielle Hypertonie
    • Akute oder chronische Infektion
    • Leber- oder Nierenfunktionseinschränkung
    • Psychiatrische Erkrankung
    • Klaustrophobie
    • Metallische Gegenstände im oder am Körper (Kotraindikation gegen MR-Untersuchung)
    E.5 End points
    E.5.1Primary end point(s)
    Changes in myocardial lipid content (assessed by MR-spectroscopy)
    Veränderungen d. myokardialen Lipidgehalts (erhoben via MR-Spektroskopie)
    E.5.1.1Timepoint(s) of evaluation of this end point
    study day 28
    28.Studientag
    E.5.2Secondary end point(s)
    Changes in:
    - left-ventricular function
    - retinopathy
    - microalbuminuria
    - beta-cell-function
    - biomarkers of endothelial dysfunction
    Veränderungen d.:
    - linksventrikulären Funktion
    - Augenhintergrundes
    - Mikroalbuminurie
    - Beta-Zell-Funktion
    - Biomarker der endothelialen Dysfunktion
    E.5.2.1Timepoint(s) of evaluation of this end point
    study day 28
    28. Studientag
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    prevention of acute secondary complications
    Prävention akuter Sekundärkomplikationen
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    konventionelle Insulintherapie
    conventionel insulin therapy
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    Trial end is scheduled for June, 30th 2014 (last patient visit).
    Der letzte Studientag ist für den 30.06.2014 terminisiert.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 32
    F.1.3Elderly (>=65 years) No
    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 state32
    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)
    according to routine care in the outpatient clinic of Division of Endocrinology and Metabolism of the Medical University of Vienna
    Routine Kontrollen in der Diabetesambulanz der Abt.f.Endokrinologie und Stoffwechsel der Medizinischen Universität Wien
    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 Decision2012-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-17
    P. End of Trial
    P.End of Trial StatusOngoing
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