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    Summary
    EudraCT Number:2014-004418-27
    Sponsor's Protocol Code Number:HS02/2014
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-18
    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 ConcernedAustria - BASG
    A.2EudraCT number2014-004418-27
    A.3Full title of the trial
    Standardized tight blood glucose management versus usual glycaemic control in patients undergoing allogeneic stem cell transplantation – a pilot trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can good blood glucose control be reached with a decision support system in patients who underwent stemm cell transplantation
    A.3.2Name or abbreviated title of the trial where available
    The GISMO Trial
    A.4.1Sponsor's protocol code numberHS02/2014
    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 SponsorMedizinische Universität Graz, Universitätsklinik für Innere Medizin, Klin. Abt. f. Endokrinologie und Stoffwechsel
    B.1.3.4CountryAustria
    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 supportEuropean Commission
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Graz, Universitätsklinik
    B.5.2Functional name of contact pointSubinvestigator
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 15
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number+4331638586113
    B.5.5Fax number+433163858017
    B.5.6E-mailfelix.aberer@medunigraz.at
    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 S.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 in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN ASPART
    D.3.9.1CAS number 116094-23-6
    D.3.9.4EV Substance CodeSUB08195MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    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 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.IMP: 2
    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 Lantus
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis
    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 nameLantus
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hyperglycaemic patients
    Patienten mit erhöhten Blutzuckerwerten
    E.1.1.1Medical condition in easily understood language
    Patients with high blood glucose
    Patienten mit erhöhten Blutzuckerwerten
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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
    To determine the feasibility of a randomized controlled trial investigating tight glycaemic control versus usual glycaemic management in subjects undergoing allogenic stem cell transplantation and after episodes of graft versus host reactions.
    E.2.2Secondary objectives of the trial
    -To investigate the feasibility of the GlucoTab system in patients with steroid induced hyperglycaemia (values in target, hypo- and hyperglycaemic events)
    -To evaluate acceptance and satisfaction of medical and nursing staff
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age between 18 and 60 years
    •Patients after allogeneic stem cell transplantation who are hospitalized for GVHD and have overt hyperglycaemia requiring glucose lowering treatment
    •Signed informed consent
    E.4Principal exclusion criteria
    •Known or suspected allergy to certain insulin types, named in the user manual
    •Total parenteral nutrition
    •Any mental condition rendering the patient incapable of giving his consent
    E.5 End points
    E.5.1Primary end point(s)
    The aim of this pilot study is to investigate whether tight glycaemic control by use of the GlucoTab device in subjects after HCT who develop GVHD is feasible to improve glycaemic control as compared to usual practice and to gain the required data on complication rates to finally plan a definitive multicenter trial to investigate the impact of a standardized, computer aided tight glycaemic control on complication rates and mortality in haematological patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Length of Gluco Tab Treatment
    E.5.2Secondary end point(s)
    •Number of hypoglycaemic episodes requiring third party help
    •Number of blood glucose measurements per day
    •Number of missed blood glucose measurements per day
    •Number of additionally required blood glucose measurements
    •Insulin dose - basal, bolus and corrective insulin dose per day
    •Number of insulin injections per day
    •Number and reasons for non-performance of insulin injections per day
    •Relevant concomitant medication (corticosteroids, parenteral bolus nutrition)

    Usability
    •Adherence to the insulin dose suggestion of the GlucoTab system
    •User satisfaction with the GlucoTab system regarding the user interface and the provided functionality
    •Malfunctions of the GlucoTab system
    •Other usability parameters like user workload and support of treatment workflow

    Efficacy
    •Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day
    •Mean pre-breakfast blood glucose, mean pre-lunch blood glucose, mean pre-dinner blood glucose, mean bedtime blood glucose
    •Mean pre-enrolment blood glucose
    •Number and percentage of the following ranges: 0-<40 mg/dl, 40-<70 mg/dl, 70-<100 mg/dl, 100-140 mg/dl, >140-<180 mg/dl, 180-<300 mg/dl, ≥ 300 mg/dl.
    •Time of glucose measurements in the following ranges: 0-<40 mg/dl, 40-<70 mg/dl, 70-<100 mg/dl, 100-140 mg/dl, >140-<180 mg/dl, 180-<300 mg/dl, ≥ 300 mg/dl
    E.5.2.1Timepoint(s) of evaluation of this end point
    Length of hospital stay and gluco tab treatment
    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 Yes
    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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Different usual insulin management
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 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 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: 10
    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 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 2015-03-18. 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 Yes
    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 state10
    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)
    Considering the patient´s glucose values and therapy during GlucoTab treatment the physician is able to recommend further medication when patient is discharged or transferred. When patient returns to the ward therapy supported by the GlucoTab system is restarted as indicated by the treating physician. A rescreening has not to be proceeded, the screening number will be the former one. Merely in- and exclusion criteria has to be checked again.
    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 Decision2015-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-26
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