Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43935   clinical trials with a EudraCT protocol, of which   7309   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2009-014894-42
    Sponsor's Protocol Code Number:NN304-3785
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-23
    Trial results View results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2009-014894-42
    A.3Full title of the trial
    A 26-week randomised, controlled, open label, multicentre, multinational, treat to target trial investigating the impact of dietary intervention on weight change and the relationship between weight change and baseline body mass index (BMI) in subjects with type 2 diabetes inadequately controlled on oral antidiabetic drugs (OADs) initiating insulin therapy with insulin detemir in combination with metformin
    Ensayo aleatorizado, controlado, abierto, multicéntrico, multinacional, de 26 semanas de duración, con ajuste de dosis para investigar los efectos de la intervención dietética sobre el cambio en el peso corporal y la relación entre el cambio en el peso corporal y el índice de masa corporal (IMC) basal en pacientes con diabetes tipo 2 mal controlada en tratamiento con antidiabéticos orales (ADO) que están empezando el tratamiento con insulina detemir en combinación con metformina
    Levemir&#61666; DIET&#61668;
    A.3.2Name or abbreviated title of the trial where available
    Levemir® DIET?
    A.4.1Sponsor's protocol code numberNN304-3785
    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.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.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. name LEVEMIR 100 U/ml, solución inyectable en una pluma precargada
    D. of the Marketing Authorisation holderNOVO NORDISK A/S
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.9.3Other descriptive nameINSULIN DETEMIR
    D.3.10 Strength
    D.3.10.1Concentration unit EID50 50% Embryo Infective Dose
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 mellitus tipo 2
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level HLT
    E.1.2Classification code 10012602
    E.1.2Term Diabetes mellitus (incl subtipos)
    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 treat-to-target treatment with insulin detemir once-daily (OD) combined with metformin accompanied with dietary intervention is superior to treat-to-target treatment with insulin detemir OD combined with metformin without dietary intervention with respect to weight change after 26 weeks of treatment in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without other OADs.
    Investigar si el tratamiento de ajuste de dosis con insulina detemir una vez al día (OD) combinada con metformina e intervención dietética es superior al tratamiento de ajuste de dosis con insulina detemir OD combinada con metformina sin intervención con respecto al cambio en el peso corporal después de 26 semanas de tratamiento en pacientes con diabetes tipo 2 diabetes mal controlada en tratamiento con metformina con o sin otros ADO.
    E.2.2Secondary objectives of the trial
    ? To investigate the association between weight change at 26 weeks and baseline BMI
    ? To assess and compare efficacy after 26 weeks of treatment
    ? To assess and compare safety and tolerability after 26 weeks of treatment
    • Investigar la asociación entre el cambio en el peso corporal a la 26 semanas y el IMC basal
    • Evaluar y comparar la eficacia del tratamiento después de 26 semanas
    • Evaluar y comparar la seguridad y tolerabilidad del tratamiento después de 26 semanas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Type 2 diabetes (diagnosed clinically) for ? 6 months prior to screening
    ? Insulin naive subjects
    ? Current treatment: metformin monotherapy or metformin in any combination with the following OADs: insulin secretagogue (SU or glinide), DPP-4 inhibitor, ?-glucosidase-inhibitors (acarbose), all with an unchanged total daily dosing for at least 3 months prior to screening
    ? HbA1c 7.0-9.0 % (both inclusive) at screening by central laboratory analysis
    ? BMI 25.0-45.0 kg/m2 (both inclusive) measured at screening
    • Diabetes tipo 2 (clínicamente diagnosticada) durante &#8805; 6 meses antes de la visita de selección
    • No tratados anteriormente con insulina
    • Tratamiento actual: metformina en monoterapia o metformina en combinación cualquier de los siguientes ADO: secretagogos de insulina (SU o glinida), inhibidor de DPP-4 e inhibidores de la &#945;-glucosidasa (acarbosa), todos a una dosis total diaria sin cambios durante al menos 3 meses antes de la visita de selección
    • HbA1c 7,0 9,0 % (ambos inclusive) en visita de selección, basandose en los resultados de laboratorio central
    • IMC 25,0 45,0 Kg/m2 (ambos) calculado en la visita de selección
    E.4Principal exclusion criteria
    ? Use of: TZDs or Glucagon-like peptide-1 analogue (GLP-1) receptor agonists within the last 3 months prior to Visit 1
    ? Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (MAO inhibitors)
    ? Anticipated initiation or change in concomitant medication known to affect weight, such as weight loss/modifying medication (e.g. sibutramine, orlistat, thyroid hormones), steroids (e.g. corticosteroids, progesterone, testosterone) and diuretics
    ? Any conditions that the investigator judges would interfere with trial participation or evaluation of the results
    ? Known or suspected allergy to insulin detemir or related products
    • Tratamiento con una TZD o un agonista del receptor del análogo del péptido-1 similar al glucagón (GLP-1) en los 3 meses anteriores a la Visita 1
    • Cambio previsto en un medicamento concomitante que interfiere de forma significativa en el metabolismo de la glucosa, tales como los corticoesteroides sistémicos, los &#946;-bloqueantes y los inhibidores de la monoaminooxidasa (IMAO)
    • Inicio de o cambio previsto en un medicamento concomitante que afecta al peso corporal, tales como los medicamentos para perder peso (p. ej., sibutramina, orlistat, hormonas tiroideas), esteroides (p. ej., corticoesteroides, progesterona, testosterona) y los diuréticos
    • Cualquier enfermedad o trastorno médico que, a juicio del investigador, pudiera interferir en la participación del paciente en el ensayo clínico o en la evaluación de los resultados del mismo
    • Alergia conocida o sospecha de alergia a la insulina detemir o productos relacionados
    E.5 End points
    E.5.1Primary end point(s)
    Weight change from baseline to end of the treatment period
    Cambio en el peso corporal con respecto al valor basal al final del periodo de tratamiento
    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 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. 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. description
    With or without dietary consultation (con o sin interveción de dieta)
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Se define como la última visita del ultimo paciente.
    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 days2
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days2
    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 2010-06-23. 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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 1000
    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)
    Not applicable
    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 Decision2010-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-14
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands