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    Summary
    EudraCT Number:2007-000123-18
    Sponsor's Protocol Code Number:NN304 - 1833
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-24
    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 ConcernedFinland - Fimea
    A.2EudraCT number2007-000123-18
    A.3Full title of the trial
    A randomised, controlled, parallel, open-labelled, multinational, trial comparing the efficacy and safety of step-wise addition of insulin aspart according to the largest meals (Basic Basal Plus regimen) or the largest prandial increments (Advanced Basal Plus regimen) in combination with once daily insulin detemir and OAD treatment, in subjects with type 2 diabetes
    A.4.1Sponsor's protocol code numberNN304 - 1833
    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 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 Solution for 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.3.10 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.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 Levemir
    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 Solution for 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 Detemir
    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
    type 2 diabetes
    MedDRA Classification
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate if IAsp added step-wise (1-2-3) in a Basic regimen (according to the largest meal, and titrated based mainly on pre-meal SMPG) is equivalent to IAsp added step-wise (1-2-3) in an Advanced regimen (according to the largest prandial increment, and titrated based mainly on post-meal SMPG) as measured by HbA1c after 36 weeks of treatment in subjects with type 2 diabetes treated with once daily IDet in combination with OAD(s).
    E.2.2Secondary objectives of the trial
    To compare the proportion of subjects achieving HbA1c levels <7.0% at 11, 23 and 36 weeks with IAsp at the largest meal (Basic Basal Plus regimen) vs. IAsp at the meal with the largest prandial increment (Advanced Basal Plus regimen), both as add-on to IDet and OADs●To compare the FPG at 36 weeks●Compare the average prandial increments●Compare the % of subjects with post prandial PG readings above 8.0 mmol/L or 11.1 mmol/L ●Compare the safety profile as measured by occurrence of AEs●Compare the safety profile as measured by changes in lab. safety parameters, physical examination, and vital signs●Compare the relative incidence of hypoglycaemia●Other objectives●Compare changes in body weight, BMI, waist/hip circumference●Evaluate the distribution of bolus injections by meal and number of boluses●Evaluate insulin doses●Evaluate the average daily bolus insulin doses●Assess the distribution of subjects on 1, 2 or 3 boluses of IAsp●Assess and compare Patient Reported Outcomes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed informed consent obtained before any trial-related activities (Trial related activities are any procedure that would not have been performed during the normal management of the subject)
    2.Type 2 diabetes mellitus ≥ 6 months (at visit 2)
    3.Age ≥ 18 years (at visit 1)
    4.HbA1c ≥ 7.5% and < 10.0% (at Visit 1)
    5.BMI < 40.0 kg/m2
    6.Basal insulin treatment (NPH once or twice daily, insulin glargine once daily or IDet once daily) for at least 3 months (at Visit 2)
    7.Treatment with 1-3 OADs
    a.Metformin ≥ 1500 mg daily or highest tolerable dose
    b.± SU ≥ 50% of maximum dose (in accordance with local labelling)
    c.± Pioglitazone or Rosiglitazone in accordance with local labelling
    8.Able and willing to perform SMPG testing as per protocol
    9.Able and willing to eat 3 main meals each day during the trial
    10.Able and willing to adhere to the therapeutic regimens
    E.4Principal exclusion criteria
    1.Known or suspected allergy to trial product(s) or related products
    2.Previous participation in any trial for the last 3 months
    3.Previous participation in this trial defined as past inclusion at visit 2
    4.Women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 50 weeks or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice).
    UK: Adequate contraceptive measures are defined as sterilisation, intra-uterine device, oral contraceptives or consistent use of barrier methods
    5.Use of more than 1 U/kg of basal insulin daily (at Visit 1)
    6.Treatment with α-glucosidase inhibitors (at Visit 1)
    7.Treatment with GLP-1 mimetics or DPP-IV inhibitors (at Visit 1)
    8.Active proliferative retinopathy or maculopathy requiring treatment within 6 mnths prior to screening
    9.Cardiac disease defined as NYHA class III or IV, unstable angina and/or myocardial infarction within 6 months prior to screening
    10.Uncontrolled hypertension (treated or untreated) as judged by the Investigator
    11.Any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial
    12.Recurrent (> 2 episodes) hypoglycaemia with PG < 3.1 mmol/L (55.8 mg/dL) within the last month or hypoglycaemic unawareness as judged by the investigator
    13.Use of concomitant medication which may alter glucose metabolism including but not limited to: systemic (or inhaled) glucocorticoids or non-selective beta-blockers
    14.Substance abuse including abuse of anabolic steroids
    15.Mental incapacity or language barrier precluding adequate understanding and/or cooperation
    16.Any condition that the investigator and/or Sponsor consider a potential obstacle to trial participation and/or data analysis
    17.Treatment with other insulin than those described in inclusion criteria no. 6

    E.5 End points
    E.5.1Primary end point(s)
    Key Efficacy Endpoints
    •HbA1c (cf. Section 8.2.1)
    •1-, 4-, 6- and 7-point SMPG profiles (cf. Section 8.2.4)
    •FPG (laboratory analysis)(cf. Section 8.2.3)

    Key safety Endpoints
    •AEs (cf. Section 8.3.1)
    •Hypoglycaemic episodes (cf. Section 8.3.2)
    •Haematology (cf. Section 8.3.5)
    •Biochemistry (cf. Section 8.3.6)
    •Lipids (cf. Section 8.3.3)
    •Physical examination (cf. Section 8.3.8)
    •Vital signs (cf. Section 8.3.7)
    •CV risk markers (cf. section 8.3.4)
    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 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
    2 regimen with the same IMP's
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 years
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial months16
    E.8.9.2In all countries concerned by the trial days13
    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 2007-07-24. 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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 336
    F.4.2.2In the whole clinical trial 512
    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 Decision2007-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-16
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