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    Summary
    EudraCT Number:2015-005619-33
    Sponsor's Protocol Code Number:NN8022-4272
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-005619-33
    A.3Full title of the trial
    Effect and safety of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus treated with basal insulin
    Efficacia e sicurezza di liraglutide 3 mg in soggetti con diabete mellito tipo 2 in sovrappeso e in stato di obesit¿ in trattamento con insulina basale.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect and safety of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus treated with basal insulin
    Efficacia e sicurezza di liraglutide 3 mg in soggetti con diabete mellito tipo 2 in sovrappeso e in stato di obesit¿ in trattamento con insulina basale
    A.3.2Name or abbreviated title of the trial where available
    Effect and safety of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes m
    Efficacia e sicurezza di liraglutide 3 mg in soggetti con diabete mellito tipo 2 in sovrappeso e in
    A.4.1Sponsor's protocol code numberNN8022-4272
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1177-4903
    A.5.4Other Identifiers
    Name:SCALE¿ InsulinNumber:NN8022-4272
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNOVO NORDISK. S.P.A.
    B.1.3.4CountryItaly
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointGlobal Clinical Registry (GCR,1452)
    B.5.3 Address:
    B.5.3.1Street AddressNovo All¿
    B.5.3.2Town/ cityBagsv¿rd
    B.5.3.3Post code2880
    B.5.3.4CountryDenmark
    B.5.4Telephone numberN/A
    B.5.5Fax numberN/A
    B.5.6E-mailclinicaltrials@novonordisk.com
    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 Saxenda
    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 No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 No
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obesity
    Obesit¿
    E.1.1.1Medical condition in easily understood language
    Abnormal or excessive body fat accumulation/excess proportion of total body fat
    Accumulo anomalo o eccessivo di grasso corporeo/proporzione eccessiva del grasso corporeo totale
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    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 superiority of liraglutide 3.0 mg vs. placebo, as an adjunct to a reduced-calorie diet and
    increased physical activity, on weight loss effectiveness in subjects with overweight or obesity and type 2 diabetes mellitus (T2DM) treated with a basal insulin and up to 2 oral antidiabetic (OAD) medications (metformin, glitazone, SGLT-2 inhibitor or sulphonylurea).
    Confermare la superiorit¿ di liraglutide 3.0 mg rispetto a placebo, in aggiunta ad una dieta a ridotto apporto calorico ed intensificazione dell¿attivit¿ fisica, sulla perdita di peso in soggetti in sovrappeso o con obesit¿ e diabete mellito di tipo 2 (T2DM) trattati con insulina basale e fino a 2 farmaci antidiabetici orali (OAD) (metformina, glitazone, inibitore di SGLT-2 o sulfanilurea).
    E.2.2Secondary objectives of the trial
    1. To establish the effects of liraglutide 3.0 mg vs. placebo, as an adjunct to a reduced calorie diet and increased physical activity, on relevant efficacy endpoints in subjects with overweight or obesity and T2DM treated with basal insulin and up to 2 OADs (metformin, glitazone, SGLT-2 inhibitor or sulphonylurea)
    2. To establish the safety and tolerability of liraglutide 3.0 mg vs. placebo, as an adjunct to a reducedcalorie diet and increased physical activity, in subjects with overweight or obesity and T2DM treated with basal insulin and up to 2 OADs (metformin, glitazone, SGLT-2 inhibitor or sulphonylurea)
    1. Stabilire gli effetti di liraglutide 3.0 mg rispetto a placebo, in aggiunta ad una dieta a ridotto apporto calorico ed intensificazione dell¿attivit¿ fisica, sugli endpoint rilevanti di efficacia in soggetti in sovrappeso o con obesit¿ e T2DM trattati con insulina basale e fino a 2 OAD (metformina, glitazone, inibitore di SGLT-2 o sulfanilurea).
    2. Stabilire la sicurezza e la tollerabilit¿ di liraglutide 3,0 mg rispetto a placebo, in aggiunta ad una dieta a ridotto apporto calorico ed intensificazione dell¿attivit¿ fisica, in soggetti in sovrappeso o con obesit¿ e T2DM trattati con insulina basale e fino a 2 OAD (metformina, glitazone, inibitore di SGLT-2 o sulfonilurea).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Informed consent obtained before any trial-related activities. Trial-related activities are any
    procedures that are carried out as part of the trial, including activities to determine suitability
    for the trial
    - Diagnosed with type 2 diabetes mellitus
    - Treatment with up to 2 OADs (metformin, glitazone, SGLT-2 inhibitor or sulphonylurea),
    - Stable treatment with basal insulin according to its label (no requirement of minimum or maximum dose) for at least 90 days prior to screening, as judged by the investigator
    - HbA1c 6.0-10.0% (both inclusive)
    - BMI = 27 kg/m2
    - Age = 18 years at the time of signing informed consent
    - Modulo di consenso informato ottenuto prima di qualsiasi attività correlata allo Studio Clinico. Per attività correlate allo Studio si intende qualunque procedura espletata nell’ambito dello Studio, incluse le attività per determinarne l’idoneità.
    - Diagnosi di diabete mellito Tipo 2
    - Trattamento fino a un massimo di 2 OAD (metformina, glitazone, inibitore di SGLT-2 o sulfanilurea)
    - Trattamento stabile, a discrezione dello sperimentatore, con qualsiasi insulina basale in conformità a quanto riportato sull’etichetta (nessun requisito di dose minima o massima) per almeno i 90 giorni precedenti lo screening
    - HbA1c compresa fra 6,0-10,0% (estremi inclusi)
    - IMC (Indice di Massa Corporea) = 27 kg/m2
    - Età = 18 anni al momento della firma del modulo di consenso informato
    E.4Principal exclusion criteria
    - Diagnosis of type 1 diabetes
    - Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s
    questionnaire question 8
    - Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator
    - Unable or unwilling to perform self-monitoring of plasma glucose according to the protocol and to keep a diabetes diary
    - Treatment with any hypoglycaemic medications other than OADs and basal insulin within the past 90 days prior to screening
    - Treatment with a DPP-IV inhibitor within the past 90 days prior to screening
    - Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree or greater heart block
    - Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN2)
    - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing
    potential and not using an adequate contraceptive method (adequate contraceptive measure
    as required by local regulation or practice). For Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner
    - Use in past 90 days of medications known to induce significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
    - History of pancreatitis (acute or chronic)
    - History of major depressive disorder within the past 2 years
    - Any lifetime history of a suicide attempt
    - Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic =180 mmHg or diastolic =110 mmHg).
    - History of malignancy (except for non-melanoma skin cancer) within the past 5 years
    - Diagnosi di diabete mellito Tipo 1
    - consapevolezza di ipoglicemia nota, come indicato dallo sperimentatore in accordo alla domanda 8 del questionario di Clark
    - Gravi episodi ipoglicemici ricorrenti verificatisi nel ultimo anno, secondo il giudizio dello sperimentatore
    - Incapacità o mancata disponibilità ad eseguire un auto-monitoraggio glicemico in accordo al protocollo e a mantenere un diario del diabete
    - Trattamento con qualsiasi farmaco ipoglicemizzante diverso dagli Antidiabetici orali e all’insulina basale nei 90 giorni dello screening
    - Trattamento con un inibitore della Dipeptidil peptidasi IV (DPP-IV Dipeptidyl Peptidase-IV nei 90 giorni prima dello di screening
    - Storia recente di malattia cardiovascolare (infarto miocardico o ictus nei 6 mesi precedenti), grave insufficienza cardiaca congestizia (Classe III, IV secondo la NYHA New York Heart Association), o aritmia di secondo grado o maggiore
    - Storia familiare o personale di neoplasia endocrina multipla di tipo 2 (multiple endocrine neoplasia type 2, MEN 2) o carcinoma midollare della tiroide (Medullary Thyroids Carcinoma, MTC).
    - Paziente di sesso femminile in gravidanza, in allattamento, o che intenda iniziare una gravidanza o sia in età fertile e non utilizzi un metodo contraccettivo adeguato (misure contraccettive adeguate come richiesto dalla legge o dalla prassi locale).
    - Uso di farmaci noti per indurre una significativa perdita (ad es. farmaci dimagranti soggetti a prescrizione) o aumento di peso (ad es. uso cronico di steroidi orali, antipsicotici di seconda generazione) nei 90 giorni dallo screening
    - Storia di pancreatite (acuta o cronica)
    - Storia di disturbi depressivi maggiori nei 2 anni precedenti lo screening
    - Eventuale storia di tentato suicidio nel corso della vita
    - Trattamento pressorio inadeguato, definito come ipertensione di Grado 3 o superiore (pressione arteriosa sistolica = 180 mmHg o diastolica = 110 mmHg)
    - Storia di neoplasie maligne (escluso il carcinoma della pelle non melanoma) negli ultimi 5 anni
    E.5 End points
    E.5.1Primary end point(s)
    1. Change in body weight (%)
    2. Proportion of subjects losing at least 5% of baseline body weight
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. from baseline to week 56
    2. week 56
    E.5.2Secondary end point(s)
    1. Proportion of subjects losing more than 10% of baseline body weight
    2. Change in waist circumference
    3. Change in systolic blood pressure
    4. Change in HbA1c
    5. Change in fasting plasma glucose
    6. Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), physical functioning score
    7. Change in IWQoL-Lite for CT, mental/emotional functioning score
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. week 56
    2.-7. from baseline to week 56
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilit¿
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Canada
    Israel
    Mexico
    Turkey
    United States
    European Union
    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
    LVLS
    LVLS
    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 months5
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days28
    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) Yes
    F.1.2.1Number of subjects for this age range: 326
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 74
    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 No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 400
    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)
    None
    Nessuno
    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 Decision2016-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
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