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    Summary
    EudraCT Number:2014-003053-34
    Sponsor's Protocol Code Number:CRC2014EMPA
    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:2014-11-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-003053-34
    A.3Full title of the trial
    Randomized, double-blind, placebo controlled, crossover clinical study to analyse the effect of empagliflozin on microvascular circulation
    Randomisierte, doppelblinde, placebokontrollierte, klinische Cross-over- Studie zur Analyse des Effektes von Empagliflozin auf die
    mikrovaskuläre Zirkulation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study with randomly into groups divided patients (investigational or ineffective control medication), where neither the doctor nor the patient's know the assignment, to determine the effect of the investigational product (Empagliflozin) on the circulation in the smallest vessels of the body.
    Klinische Studie mit nach dem Zufallsprinzip in Gruppen (Prüfmedikament oder wirkungsloses Kontrollpräparat) eingeteilte Patienten, bei der weder der Arzt noch der Patient die Zuordnung in die jeweilige Gruppe kennen, um die Auswirkung des Prüfpräparates (Empagliflozin) auf die Zirkulation in den kleinsten Gefäßen des Körpers zu erforschen.
    A.3.2Name or abbreviated title of the trial where available
    Impact of Empagliflozin on microvascular circulation
    Auswirkungen von Empagliflozin auf die mikrovaskuläre Zirkulation
    A.4.1Sponsor's protocol code numberCRC2014EMPA
    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 SponsorIPPMed – Institut für Pharmakologie und Präventive Medizin GmbH
    B.1.3.4CountryGermany
    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 supportIPPmed GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Klinik 4
    B.5.2Functional name of contact pointClinical Research Unit
    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 number004991318536245
    B.5.5Fax number004991318536245
    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 Jardiance
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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 nameEmpagliflozin
    D.3.2Product code BI 10773
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEmpagliflozin
    D.3.9.1CAS number 864070-44-0
    D.3.9.3Other descriptive nameEMPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB35915
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Type 2 diabetes mellitus
    Diabetes mellitus Typ 2
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus
    Diabetes mellitus Typ 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 17.1
    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 main objective of the trial is to analyse the effect of empagliflozin on the microcirculation as assessed by the pulse wave reflection in the peripheral arterial tree (indicative of microvascular changes) with the parameters central (aortic) systolic pressure and pulse pressure, augmentation pressure, forward and backward wave amplitude.
    Das Hauptziel der Studie ist es, die Wirkung von Empagliflozin auf die Mikrozirkulation zu analysieren, bestimmt durch die Pulswellenreflexion im peripheren arteriellen Gefäßbaum (als Indikator der mikrovaskulären Veränderungen) mit den Parametern: zentraler (aortaler) systolischen Blutdruck und Pulsdruck, Druckvergrößerung, Vorwärts- und Rückwärts-gerichtete Wellenamplitude.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the trial is to analyse the effects of empagliflozin on
    -retinal capillary flow at baseline (as key measurement of vascular remodelling in the microcirculation)
    -retinal capillary flow after flicker-light provoking vasodilation, thus allowing to estimate vasodilatory capacity
    -inner and outer diameter of small retinal arterioles, thus allowing to estimate pulsed flow in the retinal circulation
    -Pulse wave velocity
    -24-h ambulatory blood pressure (brachial and central) and vascular parameters (e.g. PWV) under ambulatory conditions
    -endothelial dysfunction as assessed by the non-invasive EndoPAT 2000 device.
    -24-h urine samples (e.g. sodium, potassium, glucose and uric acid excretion)
    -Albuminuria (urinary albumin to creatinine ratio [UACR]), assessed in the 24-hour urine
    -cardiovascular and metabolic parameters, i.e. casual blood pressure, fasting plasma glucose and HbA1c
    Die sekundären Ziele der Studie sind es, die Auswirkungen von Empagliflozin zu analysieren auf:
    - den Kapillarfluss der Netzhaut zum Basiszeitpunkt (als Schlüsselmessung des Gefäßumbau in der Mikrozirkulation)
    - den Kapillarfluss der Netzhaut nach Vasodilatation durch Provokation mit Flickerlicht, um die gefäßerweiternde Kapazität abschätzen zu können
    - den inneren und äußeren Durchmesser der kleinen Netzhautarteriolen, um die gepulste Strömung in der Netzhaut abschätzen zu können
    - Pulswellen Geschwindigkeit
    - 24-h ambulanten Blutdruck (brachial und zentral) und Gefäßparameter (z.B. PWV) unter ambulanten Bedingungen
    - endotheliale Dysfunktion, wird durch das nicht-invasive EndoPAT 2000-Gerät untersucht.
    - 24-Stunden-Urin-Untersuchung (z.B.auf Natrium-, Kalium-, Glukose- und Harnsäureausscheidung)
    - Albuminurie (Urin-Albumin-Kreatinin-Ratio [UACR]), im 24-Stunden-Urin beurteilt
    - Herz-Kreislauf-und Stoffwechselparameter , z.B. Praxis-Blutdruck, Nüchternplasmaglukose 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 (females of child bearing potential must be using adequate contraceptive precautions)
    • Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit
    • Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form.
    • Typ-2-Diabetes mellitus definiert durch Nüchternglukose ≥ 126 mg / dl oder HbA1c ≥ 6,5% oder bestehende antidiabetische Medikation
    • Alter: 18 - 75 Jahre
    • Männliche und weibliche Patienten (Frauen im gebärfähigen Alter müssen adäquate Verhütungsmethoden anwenden)
    • Frauen im gebärfähigen Alter oder innerhalb der ersten zwei Jahre der Menopause müssen einen negativen Urin-Schwangerschaftstest bei der Screening-Untersuchung haben.
    • Eine schriftliche Einverständniserklärung muss in unterschriebener Form vorliegen (§ 40 Abs. 1 Satz 3 Punkt 3 AMG).
    E.4Principal exclusion criteria
    • Any other form of diabetes mellitus than type 2 diabetes mellitus
    • Use of insulin, glitazone, gliptine or SGLT-2 inhibitor within the past 3 months
    • Patients with more than one oral blood glucose lowering medication
    • Any other oral antidiabetic drug that cannot be discontinued for the study period
    • HbA1c ≥ 10%
    • Fasting plasma glucose > 240 mg/dl
    • Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 6 months prior to study inclusion
    • UACR ≥ 300 mg/g (early morning spot urine)
    • eGFR < 60 ml/min/1.73m²
    • Uncontrolled arterial hypertension (RR ≥ 180/110 mmHg)
    • Congestive heart failure (CHF) NYHA stage III and IV
    • Severe disorders of the gastrointestinal tract or other diseases which interfere the pharmacodynamics and pharmakinetics of study drugs
    • Significant laboratory abnormalities such as SGOT or SGPT levels more than 3 x above the upper limit of normal range
    • Drug or alcohol abusus
    • Pregnant or breast-feeding patients
    • Use of loop diuretics
    • History of repetitive urogenital infection per year
    • Body mass index > 40 kg/m²
    • Triglyceride levels > 1000 mg/dl
    • HDL-cholesterol levels < 25 mg/dl
    • Any patient currently receiving chronic (>30 consecutive days) treatment with an oral corticosteroid
    • History of epilepsia or history of seizures
    • Patients being treated for severe auto immune disease e.g. lupus
    • 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
    • andere Formen des Diabetes mellitus als Diabetes mellitus Typ 2
    • Einnahme von Insulin, Glitazonen, Gliptinen oder SGLT-2-Hemmern innerhalb der letzten 3 Monate
    • Patienten mit mehr als einem oralen Blutzucker senkenden Medikament
    • Einnahme anderer oraler Antidiabetika, die nicht für den Studienzeitraum abgesetzt werden können
    • HbA1c ≥ 10%
    • Nüchternblutzucker> 240 mg / dl
    • Patienten mit stattgehabten Schlaganfall, transitorisch ischämischer Attacke, instabiler Angina pectoris oder Myokardinfarkt innerhalb der letzten 6 Monate vor der Aufnahme in die Studie
    • UACR ≥ 300 mg / g (im ersten Morgenurin)
    • eGFR < 60 ml / min / 1.73m²
    • unkontrollierte arterielle Hypertonie (RR ≥ 180/110 mmHg)
    • Herzinsuffizienz (CHF) der NYHA-Stadien III und IV
    • Schwere Erkrankungen des Magen-Darm-Trakt oder andere Krankheiten, die die Pharmakodynamik und Pharmakokinetik des Studienmedikaments stören
    • Signifikante Laborveränderungen wie SGOT oder SGPT mehr als 3 x über dem oberen Normalbereich
    • Drogen-oder Alkoholabusus
    • Schwangere oder stillende Patientinnen
    • Einnahme von Schleifendiuretika
    • Patienten mit mehrfachen urogenitalen Infektionen pro Jahr
    • Body-Mass-Index> 40 kg / m²
    • Triglyceridwerte> 1000 mg / dl
    • HDL-Cholesterinspiegel <25 mg / dl
    • Aktuelle Einnahme (> 30 aufeinanderfolgende Tage) eines oralen Kortikosteroids
    • Patienten mit bekannter Epilepsie oder Krampfanfällen
    • Patienten mit schweren Autoimmunerkrankungen wie z.B. Lupus
    • Teilnahme an anderen klinischen Studien innerhalb der letzten 30 Tage vor der Screeningvisite
    • Personen mit mangelnder Protokoll- oder Medikatimentencompliance
    • Patienten, die keine schriftlichen Zustimmung unterschrieben haben zur Weiterleitung pseudonymisierter Daten im Einklang mit der Dokumentationspflicht und der Meldepflicht nach § 12 und § 13 GCP-V.
    E.5 End points
    E.5.1Primary end point(s)
    Effect of empagliflozin on parameters that are determined by pulse wave reflection in the arterial tree:
    - central (aortic) systolic pressure,
    - central (aortic) pulse pressure,
    - augmentation pressure,
    - forward wave amplitude and
    - backward wave amplitude.
    Wirkung von Empagliflozin auf Parameter, die von der Pulswellen-Reflexion im arteriellen Baum bestimmt werden:
    - Zentrale (aortaler) systolischer Druck,
    - Zentrale (aortaler) Pulsdruck,
    - Augmentationsdruck,
    - Vorwärtswellenamplitude und
    - Rückwärtswellenamplitude
    E.5.1.1Timepoint(s) of evaluation of this end point
    After first and second phase of cross-over-design
    Nach der ersten und zweiten Phase des Cross-over-Designs
    E.5.2Secondary end point(s)
    Effects of empagliflozin on:
    To evaluate the effect of empagliflozin on
    - retinal capillary flow at baseline (as key measurement of vascular remodelling in the microcirculation)
    - retinal capillary flow after flicker-light provoking vasodilation, thus allowing to estimate vasodilatory capacity
    - inner and outer diameter of small retinal arterioles, thus allowing to estimate pulsed flow in the retinal circulation
    - Pulse wave velocity
    - 24-h ambulatory blood pressure (brachial and central) and vascular parameters (e.g. PWV) under ambulatory conditions
    - endothelial dysfunction as assessed by the non-invasive EndoPAT 2000 device.
    - 24-h urine samples (e.g. sodium, potassium, glucose and uric acid excretion)
    - Albuminuria (urinary albumin to creatinine ratio [UACR]), assessed in the 24-hour urine
    - cardiovascular and metabolic parameters, i.e. casual blood pressure, fasting plasma glucose and HbA1c
    Auswirkungen von Empagliflozin auf:
    - den Kapillarfluss der Netzhaut zum Basiszeitpunkt (als Schlüsselmessung des Gefäßumbau in der Mikrozirkulation)
    - den Kapillarfluss der Netzhaut nach Vasodilatation durch Provokation mit Flickerlicht, um die gefäßerweiternde Kapazität abschätzen zu können
    - den inneren und äußeren Durchmesser der kleinen Netzhautarteriolen, um die gepulste Strömung in der Netzhaut abschätzen zu können
    - PWV
    - 24-h ambulanten Blutdruck (brachial und zentral) und Gefäßparameter (z.B. PWV) unter ambulanten Bedingungen
    - endotheliale Dysfunktion, wird durch das nicht-invasive EndoPAT 2000-Gerät untersucht.
    - 24-Stunden-Urin-Untersuchung (z.B.auf Natrium-, Kalium-, Glukose- und Harnsäureausscheidung)
    - Albuminurie (Urin-Albumin-Kreatinin-Ratio [UACR]), im 24-Stunden-Urin beurteilt
    - Herz-Kreislauf-und Stoffwechselparameter , z.B. casual Blutdruck, Nüchternplasmaglukose und HbA1c
    E.5.2.1Timepoint(s) of evaluation of this end point
    After first and second phase of cross-over-design
    Nach der ersten und zweiten Phase des Cross-over-Design
    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 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.8.5The 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
    letzte Visite vom 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 state74
    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, an oral glucose lowering drug is likely to be necessary for those patients who 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.
    Nach Abschluss der Studie wird der Teilnehmer unter der Obhut des Hausarztes stehen. Nach Abschluss der Studie wird die Behandlung durch eine orale antidiabetische Medikation bei den Patienten fortgesetzt, bei denen bereits eine orale antidiabetische Medikation vor Studienbeginn notwendig war. Dies wird dem Studienteilnehmer ausführlich erklärt und der Hausarzt wird durch einen Brief, den der Prüfer beim letzten Studienbesuch des einzelnen Studienteilnehmers verfasst, informiert.
    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 Decision2015-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-01
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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