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    Summary
    EudraCT Number:2017-001779-22
    Sponsor's Protocol Code Number:04.2017
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-05-22
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-001779-22
    A.3Full title of the trial
    The Effect of Empagliflozin on Cardiac and Kidney Metabolism in Persons with Type 2 Diabetes
    Effekten af Empagliflozin på metabolismen i hjertet og nyrerne hos personer med type 2 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Effect of Jardiance on Cardiac and Kidney Metabolism in Persons with Type 2 Diabetes
    Jardiances effekt på energiomsætningen i hjertet og nyrerne hos personer med type 2 sukkersyge
    A.4.1Sponsor's protocol code number04.2017
    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 SponsorAarhus University Hospital, Department of Endocrinology
    B.1.3.4CountryDenmark
    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 supportNovo Nordisk Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDanish Diabetes Academy
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportHealth Research Fund of Central Denmark Region
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAarhus University
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointDepartment of Endorcrinology
    B.5.3 Address:
    B.5.3.1Street AddressNørrebrogade 44
    B.5.3.2Town/ cityAarhus C
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.6E-mailkatrine.mj@rm.dk
    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
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 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 placeboCapsule, hard
    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
    Diabetes, type 2
    Diabetes, type 2
    E.1.1.1Medical condition in easily understood language
    Diabetes, type 2
    Sukkersyge, type 2
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 100000072461
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Empagliflozin is a sodium–glucose cotransporter 2 (SGLT-2) inhibitor, and is used in treatment of diabetes type 2. It is previously shown that SGLT-2 inhibitors have a remarkable protective effect on the heart by reducing death caused by cardiac diseases with 38%. The reasons for these effects are still unknown, but it is known that SGLT-2 treatment increase ketogenesis. We have in a previous study found that ketone body infusion shifts cardiac metabolism towards ketone body oxidation, which possibly increases cardiac efficiency. It is also shown that SGLT-2 inhibitors have reno protective effects. The aim of this study is to examine the effects of SGLT-2 treatment by:
    - Examination of substrate metabolism in heart and kidney measured by PET.
    - Examination of perfusion and total energy consumption in the heart and kidney measured by PET.
    - Indirect calorimetry, bloodsamples, fat- and muscle biopsies, DXA-scan, measurement of arterial stiffness and oral glucose tolerance test.
    Empagliflozin er en såkaldt sodium–glucose cotransporter 2 (SGLT-2) hæmmer, og bruges til behandling af type 2 sukkersyge. Det har vist sig, at SGLT-2 hæmmere har en bemærkelsesværdig beskyttende effekt på hjertet, ved at reducere død pga. hjertesygdom med 38%. Baggrunden herfor er endnu ikke belyst, men det er vist, at behandlingen øger ketonstofdannelse. Vi har i et tidligere studie fundet, at infusion af ketonstof skifter hjertets forbrænding over mod ketonstofforbrænding, hvilket potentielt forbedrer hjertets energiudnyttelse. Det er også vist, at SGLT-2 hæmmerne har en betydelig nyrebeskyttende effekt. Formålet med dette forsøg er således at undersøge SGLT-2 hæmmeres beskyttende effekt på hjertet og nyrerne ved:
    - Undersøgelse af substrat metabolisme i hjerte og nyrer med PET.
    - Undersøgelse af perfusion og totalt energiforbrug i hjertet og nyrerne målt med PET.
    - Indirekte kaloeriemetri, fedt- og muskelbiopsi, blodprøver, DXA, arteriel stivhed og oral glukose tolerance test.
    E.2.2Secondary objectives of the trial
    Not applicable
    Ikke angivet
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age: 50-70 years
    • Type 2 diabetes for > 1 år
    • HbA1c: 53-75 mmol/mol
    • Metformin treatment as only anti diabetic medicin
    • Alder: 50-70 år
    • Konstateret type 2 diabetes gennem >1 år
    • HbA1c: 53-75 mmol/mol
    • Metforminbehandling som eneste medicinske antidiabetiske behandling
    E.4Principal exclusion criteria
    • Diabetes for less than 1 year
    • Changes in any kind of medicine through the last one month before beginning of the study.
    • Recent acute myocardial infarction (< 1 year) , liver disease (ALAT > x 3 of upper normal range), kidney failure (eGFR<60 ml/min), current or previous cancer disease, anaemia (Hb < 6,5)
    • Previous ketoacidosis
    • Several genital infections (bacterial/fungal infections)
    • Blooddonation the last 3 months before beginning of the study
    • Participation in examinations with radioactive isotopes during the last 6 months before beginning of the study
    • Current alcohol abuse (more than 21 units per week)
    • Nykonstateret diabetes (inden for et 1 år)
    • Ændring af alt medicin en måned op til forsøgsstart.
    • Akut myokardieinfarkt inden for det sidste år, leversygdom (ALAT > x 3 af øvre normalområde), nyresvigt (eGFR<60 ml/min), aktuel eller tidligere malign sygdom, Anæmi (Hb < 6,5)
    • Tidligere ketoacidose
    • Gentagne underlivsinfektioner (bakterier/svampe)
    • Bloddonation indenfor de sidste 3 måneder inden undersøgelsen
    • Deltagelse i forsøg/undersøgelser involverende radioaktive isotoper indenfor de seneste 6 måneder
    • Aktuelt alkoholmisbrug (over 21 genstande om ugen)
    E.5 End points
    E.5.1Primary end point(s)
    Cardiac and renal:
    - Free fatty acids uptake, oxidation and re-esterification
    - Glucose uptake
    - Oxygen consumption and energy efficiency
    - Perfusion
    Hjerte og nyrer:
    - Frie fedtsyrer optag, forbrænding og reesterificering
    - Glukose optag
    - Ilt forbrug og energiudnyttelse
    - Perfusion
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 4 weeks treatment with
    - placebo
    - Empagliflozin
    Efter 4 ugers behandling med
    - placebo
    - Empagliflozin
    E.5.2Secondary end point(s)
    - Body composition (DXA)
    - Energy expenditure (Indirect calorimetry)
    - Insulin sensitivity and secretion (Oral glucose tolerance test)
    - Intracelular signalling in muscle and adipose tissue
    - Arterial stiffness
    - Krops sammensætning (DXA)
    - Energiforbrug (Indirekte kaloriemetri)
    - Insulin følsomhed og sekretion (Oral glukose tolerance test)
    - Intracellulær signallering i muskel- og fedtvæv
    - Arteriel karstivhed
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 4 weeks treatment with
    - placebo
    - Empagliflozin
    Efter 4 ugers behandling med
    - placebo
    - Empagliflozin
    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 Yes
    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 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
    Last visit of the last subject
    Sidste besøg af sidste deltager
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state12
    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)
    No different plans from the expected treatment of the condition
    Patienten overgår efter undersøgelsen til vanlig behandling
    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 Decision2017-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-19
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