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    Summary
    EudraCT Number:2009-011271-78
    Sponsor's Protocol Code Number:NN5401-3590
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-07-29
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-011271-78
    A.3Full title of the trial
    A trial comparing efficacy and safety of NN5401 with insulin glargine in insulin naive subjects with type 2 diabetes

    Ensayo para comparar la eficacia y seguridad de NN5401 frente a insulina glargina en sujetos con Diabetes tipo 2 sin tratamiento previo con insulina
    A.4.1Sponsor's protocol code numberNN5401-3590
    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 nameSIAC
    D.3.2Product code NN5401
    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.3.9.1CAS number 844439-96-9
    D.3.9.2Current sponsor codeNNC 0100-0000-0454
    D.3.9.3Other descriptive nameinsulin 454
    D.3.10 Strength
    D.3.10.1Concentration unit nmol/ml nanomole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number420
    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 nameinsulin aspart
    D.3.10 Strength
    D.3.10.1Concentration unit nmol/ml nanomole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 Lantus®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.9.1CAS number 160337-95-1
    D.3.9.3Other descriptive nameinsulin glargine
    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

    Diabetes tipo 2
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    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 confirm the efficacy of SIAC OD + metformin in controlling glycaemia with respect to change from baseline
    in HbA1c after 26 weeks of treatment. This is done by comparing the difference in change from baseline in
    HbA1c after 26 weeks of treatment between SIAC OD + metformin and insulin glargine OD + metformin to a
    non-inferiory limit of 0.4%, and if non-inferiority is confirmed to a superiority limit of 0%.
    E.2.2Secondary objectives of the trial
    To confirm superiority of SIAC OD + metformin over insulin glargine OD + metformin after 26 weeks of
    treatment in terms of:
    • Prandial plasma glucose (PG) increment at breakfast
    • Fluctuation in nocturnal interstitial glucose (IG)
    • Frequency of responders for HbA1c (<7.0%) without hypoglycaemic episodes
    • Nocturnal hypoglycaemic episodes
    • Body weight
    To compare efficacy and safety after 26 weeks of treatment in terms of:
    • Fasting plasma glucose (FPG) from central laboratory
    • 9-point self measured plasma glucose (SMPG) profile
    • Self measured plasma glucose for dose adjustments
    • Glucose profile as measured with CGM in a sub-population
    • Frequency of responders for HbA1c
    • Frequency of responders for HbA1c without hypoglycaemic episodes
    • Clinical and laboratory assessments
    • â-cell function
    • Cardiovascular risk (CV) markers
    • Adverse events (AEs)
    • Hypoglycaemic episodes
    • Insulin dose
    • Insulin antibodies
    • Patient reported outcome (PRO)
    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 defined as any
    procedure that would not have been performed during standard management of the subject)
    2. Male or female ≥ 18 years of age
    3. Type 2 diabetes mellitus (diagnosed clinically) for ≥ 6 months
    4. HbA1c 7.5-11.0% (both inclusive) by central laboratory analysis
    5. BMI ≤ 40.0 kg/m2
    6. Insulin naive subject (Allowed are: Previous short term insulin treatment up to 14 days; Treatment during
    hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
    7. Ongoing treatment with: Metformin and at least one other OAD for at least 3 months prior to randomisation
    with the minimum doses stated:
    − Metformin:(including fixed combination products) 1500 mg or maximum tolerated dose (at least 1000 mg
    daily)
    − Insulin secretagogue (sulfonylurea or glinide): Minimum half of the daily maximal dose according to approved
    labelling
    − DPP-4 inhibitor: Minimum 100 mg daily or according to approved labelling
    − Acarbose: minimum half of the daily maximal dose or maximum tolerated dose
    8. Ability and willingness to adhere to the protocol including performance of SMPG profiles according to the
    protocol
    9. Subject is likely to comply with the Investigator’s instruction
    E.4Principal exclusion criteria
    1. Anticipated change in concomitant medication known to interfere with glucose metabolism, such as systemic
    corticosteroids, beta-blockers, MAO inhibitors
    2. Off-label use of any concomitant medication, including OADs to be continued in the trial
    3. Use within the last 3 months prior to Visit 1 of GLP-1 receptor agonists and/or
    thiazolidinediones (TZDs)
    4. Anticipated significant lifestyle change during the trial, e.g. shift work (including permanent night/evening
    shift workers), as well as highly variable eating habits
    5. Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart
    failure New York Heart Association (NYHA)1 class III or IV; myocardial infarction; unstable angina pectoris; or
    coronary arterial bypass graft or angioplasty.
    6. Uncontrolled treated/untreated severe hypertension (systolic blood pressure ≥180 mm Hg and/or diastolic
    blood pressure ≥ 100 mmHg)
    7. Impaired liver function, defined as ALAT ≥ 2.5 times upper limit of normal (one retest analysed at the central
    laboratory within a week of receipt or the result is permitted with the result of the last sample being conclusive)
    8. Impaired renal function defined as serum-creatinine ≥ 125 μmol/L (≥ 1.4 mg/dL) for males and ≥ 110 μmol/
    L (≥ 1.3 mg/dL) for females or glomerular filtration rate below 60 mL/min, calculated by the Cockroft & Gault
    formula and according to local practise for metformin use (one retest analysed at the central laboratory within a
    week is permitted with the result of the last sample being conclusive)
    9. Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or
    hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the
    previous 6 months
    10. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator
    11. Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
    according to local requirements
    12. Cancer and medical history (except basal cell skin cancer or squamous cell skin cancer)
    13. Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in
    the Investigator’s opinion could interfere with the results of the trial
    14. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding
    or co-operation, including subjects not able to read or write
    15. Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures
    is allowed only once within the limits of the recruitment period
    16. Known or suspected allergy to any of the trial products or related products
    17. Receipt of any investigational drug within one month prior Visit 1
    18. Donation of blood or participation in other trials within one month prior to Visit 1
    19. Known or suspected abuse of alcohol, narcotics or illicit drugs
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in HbA1c after 26 weeks of treatment (analysed by central laboratory)
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days21
    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 2009-07-29. 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 state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 221
    F.4.2.2In the whole clinical trial 752
    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 Decision2009-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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