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    Summary
    EudraCT Number:2008-004537-19
    Sponsor's Protocol Code Number:2008-004537-19
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-07-17
    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 ConcernedSweden - MPA
    A.2EudraCT number2008-004537-19
    A.3Full title of the trial
    Effekt av insulininfusion på sjukdomsförloppet vid infekterade fotsår samt vid thorax- och kärlkirurgi hos patienter med diabetes
    A.4.1Sponsor's protocol code number2008-004537-19
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKarolinska Universitetssjukhuset
    B.1.3.4CountrySweden
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 NovoRapid
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInsulin aspartat
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    infekterat fotsår
    kärl eller thoraxkirurgisk operation
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012664
    E.1.2Term Diabetic foot ulcer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011090
    E.1.2Term Coronary artery surgery
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012601
    E.1.2Term Diabetes mellitus
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10048038
    E.1.2Term Wound infection
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primär frågeställning
    Ger intravenös insulinbehandling bättre metabol kontroll jämfört med traditionellt givet insulin i samband med akut infektion hos patienter med diabetes?

    Sekundär frågeställning
    Ger intravenös insulinbehandling bättre metabol kontroll jämfört med traditionellt givet insulin i samband med planerad kärl- eller thoraxkirurgi på patienter med diabetes?
    E.2.2Secondary objectives of the trial
    Sekundära frågeställningar för patienter med infekterade fotsår (delstudie A)
    Leder intravenös insulinbehandling jämfört med traditionellt givet insulin i samband med akut infektion i fotsår hos patienter med diabetes till:
    a) större andel patienter med hävd fotsårsinfektion dag 6, dag 14 och 28
    b) förbättrad sårläkning
    c) förbättrad insulinkänslighet
    d) förbättrad transkutan syretension vid sårområdet
    e) förbättrad endotelfunktion
    f) kortare vårdtid


    Sekundära frågeställningar för patienter som ska genomgå planerad kärl- eller thoraxkirurgi (delstudie B)

    Leder intravenös insulinbehandling jämfört med traditionellt givet insulin i samband med planerad kärl- eller thoraxkirurgi hos patienter med diabetes till:
    a) förbättrad sårläkning
    b) lägre frekvens postoperativa sårinfektioner
    c) lägre frekvens postoperativa sårkomplikationer
    d) förbättrad insulinkänslighet
    e) förbättrad endotelfunktion
    f) kortare vårdtid
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patienter som har lämnat skriftligt samtycke till att delta i studien
    • 18 år eller äldre
    • Uppfyller något av följande
    a. Patienter med diabetes typ I eller II som vårdas på sjukhus p.g.a. akut infektion i fotsår och har högt blodsocker (kapillärt/ venöst p-glukos över 8 mmol/L)
    b. Patienter med Diabetes typ I eller II som ska genomgå kärl- eller thoraxkirurgisk operation.
    E.4Principal exclusion criteria
    • Medvetandepåverkan:= ej kontaktbar
    • Ketoacidos: pH mindre än eller lika med 7.30
    • Hyperosmolärt syndrom: S-Na mer än eller lika med 150 mmol/L
    • Njursvikt (S-kreatinin mer än 200 µmol/L eller kreatininclearance <30ml/min)
    • Graviditet eller amning
    • Medverkan i annan klinisk läkemedelsprövning inom tre månader före studiestarten
    • Risk för hotande amputation inom 2 månader efter studiestart
    • Genomgången hjärtinfarkt inom 3 månader före studiestarten
    • Om prövaren av någon annan orsak bedömer patienten olämplig för inklusion. T.ex. vid förekomst av vissa andra allvarliga sjukdomar (t.ex. AIDS/HIV-positiv, cancer.)
    E.5 End points
    E.5.1Primary end point(s)
    Primär endpoint delstudie A och B
    Genomsnittsvärde av blodsockernivåer, 8 mätningar per dygn under 4 dygn

    Sekundära endpoints
    Sekundära endpoints patienter med infekterade fotsår (delstudie A):

    a) Sårinfektion
    • Andel patienter med hävd infektion

    • sårskattningsskalans infektionsparametrar

    • Infektionsstatus (LPK, CRP, cytokiner, temperatur)


    b) Sårläkning
    •såryta
    •sårstatus (sårskattningsskala).

    c)insulinkänslighet
    • insulindoser, IGFBP-1 och IGF-1

    d) Syrgastension (TcPO2)

    e) Endotelfunktion
    •endotelmarkörer (von Willenbrants faktor, E-Selectin, ICAL, VCAM)

    f) Vårdtid
    • Antal sjukhusvårddagar

    Sekundära endpoints patienter som ska genomgå planerad kärl- eller thoraxkirurgi (delstudie B):

    a) Sårläkning
    • Läkt sår definieras som fullständig epitelialisering, samt att det inte finns behov av sårförband.

    b) Postoperativa sårinfektioner
    • Andel patienter som har infekterat operationssår utvärderas med ASEPSIS score. Poäng över 20 på skalan anses vara sårinfektion

    • Infektionsstatus (LPK, CRP, cytokiner, temperatur)

    c) Postoperativa sårkomplikationer
    • Infekterat operationssår eller annan sårkomplikation

    d) Insulinkänslighet
    • insulindoser, IGFBP-1 och IGF-1 i relation till genomsnittsvärde av blodsockernivåer under 4 dygn

    e) Endotelfunktion
    endotelmarkörer (von Willenbrants faktor, E-Selectin, ICAL, VCAM)

    e) Vårdtid
    Antal sjukhusvårddagar
    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 Yes
    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 Information not present in EudraCT
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Information not present in EudraCT
    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 undergoing the trial.
    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 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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-07-17. Yes
    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 state80
    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)
    Normal treatment
    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 Decision2009-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-09
    P. End of Trial
    P.End of Trial StatusOngoing
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