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    Summary
    EudraCT Number:2006-004731-29
    Sponsor's Protocol Code Number:NN1998-1617
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-04-18
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2006-004731-29
    A.3Full title of the trial
    Inhaled preprandial human insulin with the AERx® iDMS versus subcutaneous injected insulin aspart in subjects with diabetes and chronic obstructive pulmonary disease: A 52-week, open-label, multicentre, randomised, parallel trial to investigate long-term safety
    A.4.1Sponsor's protocol code numberNN1998-1617
    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 SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 No
    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 nameAERx iDMS
    D.3.2Product code NN1998
    D.3.4Pharmaceutical form Inhalation vapour, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNinsulin human
    D.3.9.1CAS number 11061-68-0
    D.3.9.2Current sponsor codeNN1998
    D.3.9.3Other descriptive nameAERx iDMS
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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.IMP: 2
    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.2.1.1.1Trade name NovoRapid
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    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 Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 Strength
    D.3.10.1Concentration unit IU/ml international 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
    Type 1 Diabetes
    Type 2 Diabetes
    COPD
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045228
    E.1.2Term Type I diabetes mellitus
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to evaluate the long term pulmonary safety profiles comparing preprandial inhaled human insulin with preprandial subcutaneous (s.c.) injections of insulin aspart, both in combination with basal insulin and/or OADs, in subjects with diabetes and COPD.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare the two treatments with respect to:
    •Long term safety profiles as measured by laboratory parameters, ECG, funduscopy/ fundusphotography, body weight, vital signs, physical examination and adverse events.
    •Incidence of hypoglycaemic episodes
    •Glycaemic control as measured by HbA1c and fasting plasma glucose (FPG)
    •Patient reported outcomes (PRO)
    •Bolus insulin doses

    and further to:
    •Evaluate the number and type of AERx® iDMS complaints
    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 procedure that would not have been performed during normal management of the subject.)
    2.Able and willing to perform self-monitoring of plasma glucose according to the protocol and able to keep a diary
    3.Diagnosis of type 1 or type 2 diabetes, i.e.:
    •Type 1 diabetes with an HbA1c ≤ 11.0 % and treated continuously with basal/bolus insulin for at least six months or
    •Type 2 diabetes with an HbA1c ≤ 11.0 % and treated continuously with basal/bolus insulin for at least three months or
    •Type 2 diabetes with an HbA1c ≥ 7.5% and ≤ 11.0 % and treated continuously with basal insulin (with or without an OAD(s) (except rosiglitazone if not approved in combination with insulin) for at least two months or
    •Type 2 diabetes with an HbA1c ≥ 7.5% and ≤ 11.0 % and treated continuously with one or more OADs (except rosiglitazone if not approved in combination with insulin) for at least two months
    4.Willing to continue on previous antidiabetic treatment
    5.Males and females, age ≥ 30 years
    6.Body Mass Index (BMI) ≤ 40 kg/m2
    7.Clinical diagnosis of stable COPD. The COPD is limited to GOLD stages I-III (see protocol for classification table) and the exact classification is performed by the local pulmonary clinic also responsible for the PFT measurements.
    E.4Principal exclusion criteria
    1.Participated in another clinical trial and received an investigational drug within the last 4 weeks
    2.Previous treatment with inhaled insulin (other than AERx for more than a total of seven days)
    3.Previous participation in this trial. Participation is defined as randomisation
    4.Current regular smoking or regular smoking within the last six months (regular smoking is defined as one cigarette or an equivalent amount of smoking tobacco per day or a positive urine cotinine test on laboratory test, except if resulting from non-inhaled tobacco products)
    5.Chest X-ray with clinical significant pulmonary abnormalities (excluding changes of COPD) as evaluated by a radiologist
    6.Unresolved symptoms and signs of an upper respiratory tract infection (URTI) within 3 weeks prior to screening or a current lower respiratory tract infection
    7.Current or past history of acute or chronic pulmonary disease (excluding COPD - GOLD stage I-III) including asthma, bronchiectasis, cystic fibrosis, sarcoidosis, pulmonary fibrosis, lung cancer or a need for long-term oxygen therapy (≥ 15 hours/day)
    8.Treatment with systemic steroid within 4 weeks prior to screening
    9.Known alpha-1-antitrypsin deficiency
    10.Positive screening for Hepatitis B antigen or Hepatitis C antibody or HIV
    11.Clinically significant, active (or over the past 12 months) disease of the cardiovascular, gastrointestinal, neurological, genitourinary, hematological systems
    12.Creatinine ≥ 2 mg/dL (≥180 µmol/L))
    13.Severe uncontrolled treated or untreated hypertension (sitting systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
    14.Proliferative retinopathy or maculopathy requiring acute treatment
    15.Total daily insulin dosage > 100 IU or U per day
    16.History of hypoglycaemia unawareness and/or recurrent severe hypoglycaemia with more than 2 severe episodes in the past year
    17. Females of childbearing potential who are pregnant, breast feeding or intend to become pregnant or are not using adequate contraceptive
    methods. Acceptable methods are: diaphragm, condom (by partner), intrauterine device in place for the last three months before trial start,
    sponge, cap with spermicide, contraceptive path, approved hormonal implant (i.e. Norplant), oral contraceptives taken without difficulty for the
    last three months before trial start, post menopausal state or sterilisation or as required by local law or practice
    18.Impaired liver function, defined as screening aspartate amino transferase (AST) or alanine amino transferase (ALT) ≥2.5 times upper normal range (one retest analysed at the central laboratory within one week is permitted with the last sample being conclusive)
    19.Known or suspected allergy to the trial products or related products
    20.Current addiction to alcohol or substances of abuse as determined by the Investigator
    21.Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation in the trial
    22.Any conditions that the Investigator judges would interfere with trial participation or evaluation of the results
    E.5 End points
    E.5.1Primary end point(s)
    •Change in PFTs (Forced Expiratory Volume during the first second (FEV1), Forced Expiratory Volume during the first six seconds (FEV6), Forced Vital Capacity (FVC), Forced Residual Capacity (FRC), Residual Volume (RV), Total Lung Capacity (TLC), and Diffusion Capacity (DL,CO)) as percent of predicted value from baseline to 52 weeks of treatment
    •Distribution of overall classification of COPD according to GOLD classification at end of 52 weeks of treatment
    •Type and frequency of inhaled and systemic medication for pulmonary symptomatology (COPD medication) during 52 weeks of treatment
    •Type, duration and frequency of COPD exacerbations, both severe (hospitalisation) and non-severe, (systemic steroids, antibiotics) during 52 weeks of treatment
    •Change in X-ray from baseline to 52 weeks of 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 No
    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) Yes
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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 2008-04-18. 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 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.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 225
    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 Decision2007-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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