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    Summary
    EudraCT Number:2013-004169-14
    Sponsor's Protocol Code Number:BMS-MB102-210
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-05
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-004169-14
    A.3Full title of the trial
    Randomized, placebo controlled, crossover clinical study to analyse the effect of dapagliflozin on microvascular and macrovascular circulation and total body sodium content
    Randomisierte, placebokontrollierte, klinische Crossover Studie um den Effekt von Dapagliflozin auf die mikrovaskuläre und makrovasculäre Zirkulation und den Natriumgehalt des Körpers zu analysieren.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, placebo controlled, crossover clinical study to analyse the effect of dapagliflozin on microvascular and macrovascular circulation and total body sodium content
    Randomisierte, placebokontrollierte, klinische Crossover Studie um den Effekt von Dapagliflozin auf die mikrovaskuläre und makrovasculäre Zirkulation und den Natriumgehalt des Körpers zu analysieren.
    A.4.1Sponsor's protocol code numberBMS-MB102-210
    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 Erlangen
    B.1.3.4CountryGermany
    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 supportBristol-Myers Squibb
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Centre
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street AddressUlmenweg 18
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number0049091318536245
    B.5.5Fax number0049091318536215
    B.5.6E-mailroland.schmieder@uk-erlangen.de
    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 holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form 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 placeboCoated 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
    Type 2 diabetes mellitus

    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10012613
    E.1.2Term Diabetes mellitus non-insulin-dependent
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    the effect of dapagliflozin on endothelial and microvascular function of the retinal circulation using Scanning-laser-Doppler-Flowmetry by assessing retinal capillary flow.
    Der Effekt von Dapagliflozin auf die endotheliale und mikrovaskuläre Funktion der retinalen Zirkulation anhand des retinalen kapillären Flusses mittels Scanning Laser Doppler Flowmetrie.
    E.2.2Secondary objectives of the trial
    the effect of dapagliflozin on central (aortic) systolic pressure, central (aortic) pulse pressure and augmentation pressure, parameters that all are determined by pulse wave reflection (i.e. arterial wall properties) in the arterial tree.
    the effect of retinal capillary flow after flicker light exposure (repeated flashes that cause vasodilatation by an in part NO dependent mechanism).
    the effect of dapagliflozin on total body sodium content by 24 hour urinary sodium analysis and by using new MRI technology (at ISI of the University of Erlangen)
    the effect of dapagliflozin on cardiovascular parameters, i.e. office blood pressure, fasting plasma glucose, postprandial glucose concentration and HbA1c
    Der Effekt von Dapagliflozin auf den zentralen systolischen Blutdruck, den zentralen Pulsdruck und den Augmentationsdruck mittels arterieller Pulswellenanalyse.
    Der Effekt von Dapagliflozin auf den retinalkapillären Fluss nach Flickerlichtanwendung.
    Der Effekt von Dapagliflozin auf den Gesamtkörpernatriumgehalt mittels 24 Stunden Urinnatriumessung und Na MRT.
    Der Effekt von Dapagliflozin auf kardiovaskuläre Parameter wie Blutdruck, Nüchternglukose, postprandiale Blutgluosekonzentration und HbA1c
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Type 2 diabetes mellitus defined by fasting glucose ≥126 mg/dl or HbA1c ≥6.5% or on blood glucose lowering medication
    Age of 18 - 75 years
    Male and Female patients are eligible. Females of child bearing potential (WOCBP) are only eligible if pregnancy test at the screening visit is negative and they use adequate contraceptive precautions during the trial.
    Diabetes mellitus Typ 2, definiert als Nüchterglucosewert ≥126 mg/dl oder HbA1c ≥6.5% oder behandelter Diabetes mellitus
    Alter 18-75 Jahre
    Männer und Frauen (bei negativem Schwangerschaftstest bei der Screeningvisite und Kontrazeption während der Studiendauer)
    E.4Principal exclusion criteria
    • age over 75 years
    • Any other form of diabetes mellitus than type 2 diabetes mellitus
    • History of diabetic ketoacidosis or hyperosmolar nonketotic coma
    • Patients with more than one oral blood glucose lowering medication or on insulin therapy
    • Any medication with loop diuretics
    • Last measured HbA1c ≥ 10%
    • Blood pressure levels ≥180/110 mmHg
    • Estimated glomerular filtration rate (eGFR < 60 ml/min/1.73m²)
    • Acute cardiovascular event (including myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, stroke, TIA. PRIND, intracerebral bleeding) <3 months prior to screening visit (visit 0)
    • Body mass index >40 kg/m²
    • Triglyceride levels >1000 mg/dl
    • HDL-cholesterol levels <25 mg/dl
    • Macroalbuminuria defined by urinary albumine-to-creatinine ratio > 300 mg/g
    • Known liver function test >3 times upper limit of normal
    • Pregnant or breast-feeding patients
    • Any patient currently receiving chronic (>30 consecutive days) treatment with an oral corticosteroid
    • Subjects with a history of any serious hypersensitivity reaction to Dapagliflozin or SGLT-2 inhibitor
    • Presence of significant renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, immunological, haematological or oncological, neurological and psychiatric diseases or dysfunction
    • Diabetic retinopathy
    • History of epilepsia or history of seizures
    • Patients suffering from cataract or glaucoma
    • History of drug medication abuse.
    • Patients being treated for severe auto immune disease e.g. lupus
    • Involvement in the planning and/or conduct of the study (applies to BMS or representative staff and/or staff at the study site)
    • Participation in another clinical study within 30 days prior to visit -1
    • Individuals at risk for poor protocol or medication compliance
    • Subject who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V
    • Prisoners or subjects who are involuntarily incarcerated.
    • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
    Alter > 75 Jahre
    andere Formen des Diabetes mellitus als Diabetes mellitus Typ 2
    anamnestisch diabetische Ketoazidose oder hyperosmolares nichtketotisches Koma
    mehr als ein Medikament zur Blutzuckersenkung oder Insulintherapie
    Schleifendiuretika
    zuletzt gemessener HbA1c ≥ 10%
    Blutdruck ≥ 180/110 mmHg
    eGFR < 60ml/min/1.73m²
    akutes kardiovaskuläres Ereignis innerhalb der letzten 3 Monate vor der Screeningvisite (Myokardinfarkt, instabile Angina pectoris, PTA, Herzinsuffizienz, Apoplex, TIA, PRIND, intracerebrale Blutung)
    BMI > 40kg/m²
    Hypertriglycerinämie >1000mg/dl
    HDL Choleserinämie < 25mg/dl
    Makroalbuminurie (Albumin Kreatininratio > 300mg/g)
    erhöhte Leberwerte (über 3fach erhöht)
    schwangere oder stillende Frauen
    Patienten mit vorrübergehender oder chronischer Behandlung (> 30 aufeinanderfolgenden Tagen) mit Glukokortikoiden
    bekannte Allergie gegen Dapagliflozin oder andere SGLT 2 Inhibitoren
    bekannte signifikante renale, respiratorische, hepatische, gastrointestinale, endokrine oder metabolische, immunologische, hämatologische oder onkologische, neurologische oder psychatrische Erkrankungen
    diabetische Retinopathie
    bekannte Epilepsie oder Anfallsleiden
    Patienten mit Katarakt oder Glaukom
    bekannte Medikamentenabusus
    bekannte behandelte Autoimmunerkrankung, z.B. Lupus
    Patienten, die an der Planung oder Durchführung der Studie beteiligt sind
    Patienten, die anderen Studien innerhalb der letzten 30 Tage vor der Screeningvisite teilgenommen haben
    Patienten mit mangelnder Compliance
    Patienten, die keine Einverständniserklärung abgegeben haben
    Gefänginsinsassen
    Patienten welche aufgrund einer psychatrischen oder somatischen Erkrankung (z.B. Infektionserkrankung) nicht teilnehmen können


    E.5 End points
    E.5.1Primary end point(s)
    The effect of dapagliflozin on endothelial and microvascular function of the retinal circulation using Scanning-laser-Doppler-Flowmetry by assessing the retinal capillary flow
    Der Effekt von Dapagliflozin auf die endotheliale und mikrovaskuläre Funktion der retinalen Zirkulation anhand des retinalen kapillären Flusses mittels Scanning Laser Doppler Flowmetrie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after second phase of crossoverdesign
    nach der zweiten Phase von 4 Wochen im Crossoverdesign
    E.5.2Secondary end point(s)
    on central (aortic) systolic pressure, central (aortic) pulse pressure and augmentation pressure, parameters that all are determined by pulse wave reflection (i.e. arterial wall properties) in the arterial tree.
    on retinal capillary flow after flicker light exposure (repeated flashes that cause vasodilatation by an in part NO dependent mechanism).
    on total body sodium content by 24 hour urinary sodium analysis and by using new MRI technology (at imaging science institute of the University of Erlangen)
    on cardiovascular parameters, i.e. office blood pressure, fasting plasma glucose, postprandial glucose concentration and HbA1c
    Der Effekt von Dapagliflozin auf den zentralen systolischen Blutdruck, den zentralen Pulsdruck und den Augmentationsdruck mittels arterieller Pulswellenanalyse.
    Der Effekt von Dapagliflozin auf den retinalkapillären Fluss nach Flickerlichtanwendung.
    Der Effekt von Dapagliflozin auf den Gesamtkörpernatriumgehalt mittels 24 Stunden Urinnatriumessung und Na MRT.
    Der Effekt von Dapagliflozin auf kardiovaskuläre Parameter wie Blutdruck, Nüchternglukose, postprandiale Blutgluosekonzentration und HbA1c
    E.5.2.1Timepoint(s) of evaluation of this end point
    after second phase of crossoverdesign
    nach der zweiten Phase von 4 Wochen im Crossoverdesign
    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) Yes
    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 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 Yes
    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 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
    LSLV
    letze Visite des letzten Patienten
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=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 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 state62
    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)
    After completing the trial the participant will be under the continuous care of his/her family physician. After completing the trial treatment of an oral glucose lowering drug is likely to
    be necessary for those patients that had received an oral glucose lowering agent prior to the
    study. This will be explained to the study participant and the family physician will be
    informed by a letter written by the investigator at the last study visit of each study participant.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-02
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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