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    Summary
    EudraCT Number:2006-006589-41
    Sponsor's Protocol Code Number:NN304-1808
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-08-13
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-006589-41
    A.3Full title of the trial
    Levemir® in ageing patients with type 2 diabetes

    A seven-month open-labelled randomised multi-centre two-group parallel trial comparing administration of insulin detemir once daily in the morning versus NPH insulin once daily in the morning in ageing subjects with type 2 diabetes.
    Trial Phase: 4
    A.3.2Name or abbreviated title of the trial where available
    The 3L Study (Levemir in Later Life)
    A.4.1Sponsor's protocol code numberNN304-1808
    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 Ltd
    B.1.3.4CountryUnited Kingdom
    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 Levemir Innolet
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    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.3.4Pharmaceutical 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.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 Insulatard Innolet
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    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 nameInsulatard
    D.3.4Pharmaceutical form Suspension 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 human, rDNA
    D.3.9.3Other descriptive nameisophane (NPH) insulin
    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 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
    The aim of the study is to compare two -basal insulin regimens as insulin therapy initiation in ageing type 2 diabetic patients with insulin detemir versus NPH insulin given once daily in the morning.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are to compare insulin detemir to NPH insulin therapy according to the following criteria, measured at 4 and 7 months (except for Quality of Life related measures which will be assessed at baseline and end of study)
    •Quality of Life (treatment satisfaction, health status, behavioural and psychosocial scoring)
    •Efficacy objectives
    - Percentage of subjects with HbA1c ≤ 8.0%
    - Glycaemic control as measured by 3-point Self Measured Plasma Glucose (SMPG) (Fasting, prelunch and predinner Plasma Glucose)
    - Within-subject variation of body weight during the trial
    - Percentage of patients achieving Fasting Plasma Glucose ≤8.8 mmol/L (160 mg/dL)
    - Within-subject variation of Plasma Glucose during the trial
    - Incidence of Hyperglycaemic episodes
    •Safety objectives
    - Incidence of hypoglycaemic episodes
    - Occurrence of adverse events during the trial
    •Insulin dose requirements
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Informed Consent must be 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.Type 2 diabetes,
    3.Subject ≥ 70 years old,
    4.Subject insulin naïve and optimally treated by oral antidiabetics drugs (OAD) at maximum tolerated dose for at least 3 months and not achieving therapeutic targets
    5.8.0% ≤ HbA1c ≤ 10.5% (local dosage within the last 6 months)
    6.Able to comply with the requirements of the trial.

    Moreover, the metabolic control appropriate for the patients to be included should target an HbA1c between 7.0% and 8.0%.
    Concomitant treatment: in case of previous metformin treatment, metformin will be continued at optimal dose, providing renal clearance assessed by MDRD > 60 ml/mn and no renal impairment occurs throughout the study. Thiazolidinediones must be discontinued at least 2 weeks before randomisation. Sulfonylureas and alpha-glucosidase inhibitors must be discontinued at randomisation.
    Elderly patients living in specific medical institutions are authorized to take part in the study, as judged by the Investigator, if they are able to give their informed consent, to understand and comply with the study procedures and if there is a benefit for the subject in taking part in the study.
    E.4Principal exclusion criteria
    1.Secondary diabetes, MODY (Maturity Onset Diabetes of the Young),
    2.Previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the Investigator),
    3.Proliferative retinopathy, maculopathy requiring treatment,
    4.Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia,
    5.End stage liver disease (increased liver enzymes 4 fold), end stage renal disease assessed by MDRD < 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months,
    6.Acute disease withpoor prognosis,
    7.History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol,
    8.Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation (patients having a score of less than 15 in a previous MMSE in the last six months) and any conditions as judged by the investigator,
    9.Legal incapacity or limited legal capacity (patients under guardianship or curatorship),
    10.Concomitant medication for Alzheimer's treatment (Memantine, Anticholinesterasique treatment),
    11.Participation in another clinical trial less than one month before inclusion in this trial,
    12.Illness requiring repeated hospitalisation,
    13.Known or suspected allergy to the insulin or any compositional component,
    14.Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
    15.Any other condition that the Investigator feels would interfere with trial participation or evaluation of results,
    16.Terminal illness
    E.5 End points
    E.5.1Primary end point(s)
    •Efficacy objectives at 4 months and 7 months
    - Glycaemic control as measured by centrally measured HbA1c
    - Glycaemic control as measured by mean self measurement of fasting plasma glucose (FPG), pre-lunch and pre-dinner plasma glucose
    - Percentage of subjects achieving HbA1c ≤8.0%
    - Percentage of subjects achieving HbA1c ≤8.0% without hypoglycaemia
    - Percentage of patients achieving mean fasting capillary glycaemia ≤8.8 mmol/L (160mg/d)
    - Within-subject variation in pre-breakfast, pre-lunch and pre-dinner capillary plasma glucose level (SMPG) during the trial
    - Incidence of hyperglycaemic episodes
    •Safety objectives
    - Incidence of hypoglycaemic episodes reported by the patient (all, major hypoglycaemic episodes when assistance to treat is required, minor hypoglycaemic episodes when plasma glucose is < 56 mg/dL (3.1mmol/L) and when the subject is able to deal with the episode himself or any symptom of hypoglycaemia if not confirmed by a plasma glucose measurement) during the trial (nocturnal and over the entire day),
    - Incidence of hypoglycaemic episodes defined as a self measured plasma glucose less than 56 mg/dL (3.1 mmol/L)
    - Occurrence of adverse events during the trial
    •Insulin doses requirements: total daily doses measured at 4 and 7 months in both groups
    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) 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.8.5The 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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 months4
    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 months4
    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) No
    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 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 state143
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 286
    F.4.2.2In the whole clinical trial 286
    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 Decision2007-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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