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    Summary
    EudraCT Number:2016-000172-19
    Sponsor's Protocol Code Number:15-124
    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:2016-11-21
    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 number2016-000172-19
    A.3Full title of the trial
    Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients with Type 2 Diabetes
    Empagliflozin als Modulator des systemischen Gefäßwiderstands und Herzzeitvolumens bei Patienten mit Typ 2 Diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Empagliflozin on Systemic Vascular Resistance and Cardiac Output in Patients with Type 2 Diabetes
    Wirkung von Empagliflozin auf systematische Gefäßwiderstand und das Herzzeitvolumen bei Patienten mit Diabetes Mellitus (Typ 2)
    A.3.2Name or abbreviated title of the trial where available
    EMPA Hemodynamics
    A.4.1Sponsor's protocol code number15-124
    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 SponsorRWTH Aachen University for the Medical Faculty, represented by Center for Transitional & Clinical Research Aachen (CTC-A
    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 supportBoehringer Ingelheim
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCenter for Transitional & Clinical Research Aachen (CTC-A)
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressPauwelsstraße 30
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52074
    B.5.3.4CountryGermany
    B.5.4Telephone number+492418080092
    B.5.5Fax number+49241803380092
    B.5.6E-mailcfera@ukaachen.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.3.4Pharmaceutical 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 INNPL1
    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 number10
    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
    Patients with Type 2 diabetes mellitus
    E.1.1.1Medical condition in easily understood language
    Patients diagnosted with diabetes mellitus typ 2 to improve glycaemic control when diet and exercise alone do not provide adequate control
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Effect of empagliflozin 10 mg once daily on cardiac output in comparison to placebo after 1 day, 3 days and 12 weeks of treatment (measured with a noninvasive monitoring [ClearSight System]).
    Die Wirkung der Behandlung mit Empagliflozin 10 mg einmal täglich gegenüber Placebo auf auf den systemischen Gefäßwiderstand und das Herzzeitvolumen bei Patienten mit Typ-2-Diabetes .
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Type 2 diabetes
    2. Serum levels of HbA1c ≥ 6.5 %
    3. Age ≥ 18 years
    4. Written informed consent prior to study participation
    5. Participants of child-bearing age should use adequate contraception
    E.4Principal exclusion criteria
    1. Type 1 diabetes
    2. Systolic blood pressure ≥ 180 mmHg, diastolic blood pressure ≥ 100 mmHg
    3. Age ≥ 75 years
    4. Pregnancy and lactating females.
    5. Renal impairment (GFR < 30 ml/min/1.73 m2)
    6. Liver disease (serum levels of AST, ALT or AP more than three times the upper limit of normal)
    7. Uncontrolled thyroid disease
    8. Endocrinopathies like Graves’ disease, acromegaly, Cushing’s disease
    9. Hypertensive retinopathy or encephalopathy
    10. Acute coronary syndrome, stroke or transient ischemic attack in last 6 weeks prior to randomization
    11. The subject is mentally or legally incapacitated
    12. The subject received an investigational drug within 30 days prior to inclusion into this study
    13. Urinary tract infections or significant formation of residual urine in medical history
    E.5 End points
    E.5.1Primary end point(s)
    Effect of Empagliflozin 10 mg once daily on systemic vascular resistance in comparison to placebo after day 1, day 3 and 12 weeks of treatment (measured with a noninvasive monitoring [ClearSight System])
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 1, day 3 and 12 weeks
    E.5.2Secondary end point(s)
    Most important secondary analysis:
    - Stroke volume (SV)
    - Stroke volume variation (SVV)
    - Resting energy expenditure (REE) (measured by indirect calorimetry [CardioCoach CO2])
    - respiratory exchange rate (RER) measured by indirect calorimetry [CardioCoach CO2])
    - Blood pressure
    - Sodium excretion in 24 h urine collection (osmolarity, sodium, potassium, creatine, chloride, creatine-clearance, protein, urea nitrogen, magnesium, phosphate, glucose, calcium, uric acid)
    - Body weight
    - Heart rate
    - NT-proBNP and cystatin C
    - Serum levels of chloride, glucose, HbA1c, glucagon, insulin, total-ketone bodies, β-hydroxybutyrate, aldosterone and free fatty acid
    - Serum osmolarity
    - Change in left ventricular function between baseline and after 12 weeks as determined by 2D and 3D parameter global Strain Rate E
    - Change in left ventricular diastolic function between baseline and after 12 weeks as determined by standardized parameter E/é and left atrial (LA) volume
    - Change in left ventricular systolic function by ejection fraction (EF)
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 1, day 3 and 12 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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 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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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
    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 months
    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 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state40
    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)
    Patients are treated according to the study protocol and in accordance with the normal standards of medical care.
    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 Decision2017-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-23
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