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    EudraCT Number:2011-005702-30
    Sponsor's Protocol Code Number:2011/1811
    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:2011-12-12
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2011-005702-30
    A.3Full title of the trial
    Interactions between exogenous Insulin Aspart, endogenous insulin and plasma glucose in type 2 diabetes mellitus patients
    Interaktioner mellem eksogent Insulin Aspart, endogent insulin og plasma glukose ved type 2 diabetes mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Interactions between synthetic insulin, body insulin and blood sugar in diabetes patients
    Samspil mellem eksogent og endogent insulin og i relation til forskellige plasma glukose (sukker) niveauer
    A.3.2Name or abbreviated title of the trial where available
    Endogenous insulin Jurgita II-2011/1811
    Endogent insulin Jurgita II-2011/1811
    A.4.1Sponsor's protocol code number2011/1811
    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 and Internal Diseases
    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 supportAarhus University
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University
    B.5.2Functional name of contact pointAarhus University
    B.5.3 Address:
    B.5.3.1Street AddressNordre Ringgade 1
    B.5.3.2Town/ cityAarhus C
    B.5.3.3Post code8000
    B.5.4Telephone number+458942 1111
    B.5.5Fax number+458942 1109
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 NovoRapid 100 IE/ml
    D. of the Marketing Authorisation holderNovo Nordisk A/S
    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 Infusion
    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.3.9.1CAS number 116094-23-6
    D.3.9.3Other descriptive nameNovoRapid
    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 to IE/ml
    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) 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 Yes
    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
    Type 2 diabetes mellitus
    Type 2 diabetes mellitus
    E.1.1.1Medical condition in easily understood language
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the pharmacokinetic profiles of endogenous insulin and exogenous Insulin Aspart (IAsp) in type 2 diabetes patients treated with continuous subcutaneous (sc) IAsp infusion via insulin pump with or without intravenous (iv) glucose infusion
    At evaluere farmakokinetiske (PK) profiler af endogent insulin og eksogent tilført Insulin Aspart (IAsp) hos type 2 DM patienter behandlet med kontinuerlig sc IAsp infusion via insulin pumpe med eller uden samtidig intravenøs (iv) tilførsel af glukose.
    E.2.2Secondary objectives of the trial
    To evaluate the pharmacodynamic (PD) glucose profiles after treatment with continuous sc IAsp infusion via insulin pump with or without iv glucose infusion.
    At evaluere farmakodynamiske (PD) glukose profiler efter behandling med IAsp indgivet som kontinuerlig sc infusion via insulin pumpe med eller uden samtidig iv tilførsel af glukose.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed and dated informed consent
    • Type 2 diabetes according to the WHO classification for at least 6 months
    • Insulin-naive patients who have never been treated with insulin
    • HbA1c < 9% according to the local laboratory
    • Women and men ≥ 35 og ≤ 75 years old
    • BMI between25 kg /m2 og 42 kg /m2, both values are included
    • Underskrevet og dateret samtykkeerklæring
    • Type 2 diabetes ifl. WHO klassifikation i minimum 6 mdr.
    • Insulin naive patienter, som aldrig før har været i behandling med insulin
    • HbA1c < 9% ifl. hospitalslab.
    • Kvinder og mænd ≥ 35 og ≤ 75 år
    • BMI mellem 25 kg /m2 og 42 kg /m2, begge værdier er inkluderet
    E.4Principal exclusion criteria
    • Suspected or known allergy to the trial drug or similar medications
    • Treatment with the drugs that after investigator judgment could potentially interfere with plasma glucose levels
    • Heart: Unstable angina pectoris, AMI < 12 months old or severe heart failure according to NYHA III-IV
    • BP: Severe uncontrolled hypertension with BP > 180/110 mmHg (in lying position)
    • Liver: Impaired liver function with plasma ALAT or alkaline phosphatase levels > 2 times the upper normal limit according to the local laboratory
    • Kidneys: eGFR< 50 ml/min/l according to the local laboratory
    • Pregnancy, lactation or desire for pregnancy in the study period and for women in childbearing age without adequate contraception-adequate contraception is: sterilisation, hysterectomy or current use of contraceptive pills, coil, gestagen depot injection, subdermal implantation, hormonal vaginal ring and transdermal depot patch.

    • Mistænkt eller kendt allergi overfor forsøgsmedikamenterne eller lignende medikamenter.
    • Behandling med lægemidler, som efter Investigators vurdering, kunne potentielt påvirke P-glukose niveauer
    • Hjerte: Ustabil angina pectoris, AMI < 12 mdr. eller hjerteinsufficiens klassificeret til NYHA III-IV
    • BT: Svær ukontrollerbar hypertension med BT > 180/110 mmHg (liggende)
    • Lever: Nedsat leverfunktion svarende til plasma-ALAT eller –basisk phosphatase > 2x øvre grænseværdi for det lokale laboratorium
    • Nyrer: eGFR< 50 ml/min/l, ifl. lokalt laboratorium
    • Enhver sygdom, som Investigator vurderer, kan påvirke forsøget
    • Graviditet, amning eller ønske om graviditet i studieperioden, samt for kvinder i den fødedygtige alder uden tilstrækkelig beskyttelse mod graviditet – tilstrækkelig er sterilisation, hysterektomi eller aktuel anvendelse af p-piller, spiral, gestagendepotinjektion, subdermal implantation, hormonal vaginalring samt transdermal depotplaster.
    E.5 End points
    E.5.1Primary end point(s)
    • PK profiles of patient serum endogenous insulin concentration curves under treatment regiment A (without iv glucose infusion) and B (with iv glucose infusion)
    • PK profiler af patientens serum endogent insulin koncentration kurver ved indlæggelser A (uden glukose tilførsel iv) og B (med glukose tilførsel iv)
    E.5.1.1Timepoint(s) of evaluation of this end point
    AUC 22-08h
    AUC 22-08h
    E.5.2Secondary end point(s)
    • PK profiles of patient serum IAsp concentration curves under treatment regiment A and B
    • PD profiles of inividual plasma glucose concentration curves under treatment regiment A and B
    • PK profiler af patientens serum IAsp koncentration kurver ved indlæggelser A og B
    • PD profiler af individuelle plasma glukose koncentration kurver ved indlæggelser A og B
    E.5.2.1Timepoint(s) of evaluation of this end point
    AUC 22-08h
    AUC 22-08h
    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 Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E. description
    Patienterne er deres egne kontroller
    The patients are own controls
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Yes
    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
    The end of the trial is the last visit of the last patient
    Afsluttning af forsøget er det sidste besøg af den sidste forsøgsperson
    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 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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 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)
    Treatment will not be changed.
    Behandlingen ændres ikke.
    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 Decision2011-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-31
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