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    EudraCT Number:2013-004527-36
    Sponsor's Protocol Code Number:PILOT_EGP
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-11-21
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2013-004527-36
    A.3Full title of the trial
    An open, non-randomized, single-center pilotstudy investigating the feasibility of determining the endogenous glucose production during a hypoglycaemic clamp in type 1 diabetes mellitus subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial investigating the feasibility of determining the liver glucose production during induced hypoglycaemic in type 1 diabetes mellitus subjects
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberPILOT_EGP
    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 / Endokrinologie und Stoffwechsel
    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 supportMedizinische Universität Graz / Endokrinologie und Stoffwechsel
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Graz / Endokrinologie und Stoffwechsel
    B.5.2Functional name of contact pointZentrum f. Med. Grundlagenforschung
    B.5.3 Address:
    B.5.3.1Street AddressStiftingtalstrasse 24
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8010
    B.5.4Telephone number+43316385 72806
    B.5.5Fax number+43316385 72839
    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. name Actrapid
    D. of the Marketing Authorisation holderNovo Nordisk, Bagsværd, Dänemark
    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 nameInsulin human
    D.3.4Pharmaceutical form Solution for injection in cartridge
    D.3.4.1Specific paediatric formulation No
    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 INNActrapid
    D.3.9.1CAS number 11061-68-0
    D.3.9.3Other descriptive nameINSULIN HUMAN REGULAR (RDNA)
    D.3.9.4EV Substance CodeSUB25234
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Diabetes Mellitus Type 1
    E.1.1.1Medical condition in easily understood language
    Metabolic disease in which a person has high blood sugar because the body does not produce enough insulin
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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 investigate the feasibility and stability of determining the endogenous glucose production during a hypoglycaemic clamp in type 1 diabetes mellitus subjects by a stable tracer to tracee ratio with an enrichment of 4% and a variation below +/- 30%
    E.2.2Secondary objectives of the trial
    To investigate the stability of the tracer to tracee ratio during the tracer steady state at the begin of the hypoglycaemic clamp with a variation below +/- 30%

    To investigate the effect of insulin given intravenously with an infusion rate of 1,5 mU/kg/min on the tracer to tracee ratio with a variation below +/- 30%

    To investigate the effect of different quantities of glucose given intravenously on the tracer to tracee ratio with a variation below +/- 30%

    To investigate the stability of the tracer to tracee ratio during 30 minutes at each plateau during the hypoglycaemic clamp

    To investigate the time to reach each glucose plateau during the hypoglycaemic clamp

    To investigate the glucose levels during the recovery phase

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
    2. Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to screening visit
    3. Male or female, aged 18 – 64 years (both inclusive)
    4. Body mass index (BMI) 18.0 - 28.0 kg/m2 (both inclusive)
    5. HbA1c 42 – 80 mmol/mol (6.0-9.5%)
    6. Treated with daily insulin injections or continuous s.c. insulin infusion (CSII) ≥ 12 months. Stable insulin dose as judged by the investigator.
    E.4Principal exclusion criteria
    1. Known or suspected hypersensitivity to trial product(s) or related products
    2. Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) as judged by the investigator
    3. Severe hypoglycaemia within 1 month of screening
    4. Hypoglycaemia unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
    5. Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis or coagulation screening tests, as judged by the investigator and any of the following laboratory safety results:
    a. ASAT, ALAT, lipase, alkaline phosphatase > 2.0 times upper limit of reference range (ULN)
    b. Haemoglobin < 8.0 mmol/L (male) or < 6.4 mmol/L (female), total leukocyte count < 3.0 x 109/L, thrombocytes <100 x 109/L
    c. Serum creatinine levels ≥ 126 µmol/L (male) or ≥ 111 µmol/L (female)
    6. Suffer from or history of a life threatening disease (e.g. cancer except basal cell skin cancer or squamous cell skin cancer), or any clinically significant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of diabetes mellitus and euthyroid struma), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders as judged by the investigator.
    7. Cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time and/or angina pectoris within the last 12 months prior to screening and/or acute myocardial infarction at any time.
    8. Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic (repeated measurement on a second screening visit allowed to exclude white-coat hypertension). This exclusion criterion also pertains to subjects being on antihypertensives.
    9. Clinically significant abnormal ECG at screening, as judged by the investigator.
    10. Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.
    11. Any disease or condition that, in the opinion of the investigator, would represent an unacceptable risk for the subject’s safety.
    12. Subject positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (or diagnosed with active hepatitis according to local practice).
    13. Positive result of the screening test for HIV-1 antibodies, HIV-2 antibodies and/or HIV-1 antigen according to locally used diagnostic testing.
    14. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
    15. Current treatment with systemic (oral or i.v.) corticosteroids, MAO inhibitors, non-selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months prior to screening.
    16. Significant history of alcoholism or drug/chemical abuse as per investigator’s judgement or a positive result in the drug/alcohol screen at the screening visit.
    17. Subject with mental incapacity or language barriers precluding adequate understanding or co operation or who, in the opinion of the investigator, should not participate in the trial.
    18. Potentially non-compliant or uncooperative during the trial, as judged by the investigator.
    19. Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator.
    20. Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive methods include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner).
    21. Use of drugs, which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilisation, or recovery from hypoglycaemia
    22. Severe acute and/or chronic diseases
    23. Diseases of the skin which could interfere with application of the catheters as judged by the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Stable tracer to tracee ratio (4% enrichment) with a variation below +/- 30% during variable GIR from the begin of the experiment until the end of the hypoglycaemic clamp
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the hypoglycaemic clamp
    E.5.2Secondary end point(s)
    • 4% of tracer to tracee ratio and MARD during the tracer steady state
    • 4% of tracer to tracee ratio and MARD affected by insulin infusion rate of 1.5mU/kg/min
    • 4% of tracer to tracee ratio and MARD affected by variable GIR
    • Stable tracer to tracee ratio obtained by highly i.v. insulin given during the hypoglycaemic clamp
    • Stable tracer to tracee ratio derived for each plateau level (5.5, 3.5 and 2.5 mmol/L and for the recovery phase 4.0 mmol/L) during the hypoglycaemic clamp
    • Time to reach each hypoglycaemic level (5.5, 3.5 and 2.2 mmol/L) and for the recovery phase
    • Stable glucose levels during the plateau (5.5, 3.5 and 2.5 mmol/L)
    • Glucose levels during the recovery phase
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the hypoglycaemic clamp
    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. 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    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: 20
    F.1.3Elderly (>=65 years) No
    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 state20
    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 the trail, there will be no need for extra care or treatment. But standard care for type 1 diabetic patients at the diabetes outpatient clinic of the Department of intneral Medicine at Medical University of Graz will be available.
    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 Decision2014-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-20
    P. End of Trial
    P.End of Trial StatusOngoing
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