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    Summary
    EudraCT Number:2013-000632-94
    Sponsor's Protocol Code Number:NN9535-3623
    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:2013-09-12
    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 number2013-000632-94
    A.3Full title of the trial
    Efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes
    Efficacia e sicurezza di semaglutide una volta a settimana verso placebo in pazienti con diabete di tipo 2 mai trattati (Naive)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes
    Efficacia e sicurezza di semaglutide una volta a settimana verso placebo in pazienti con diabete di tipo 2 mai trattati (Naive)
    A.3.2Name or abbreviated title of the trial where available
    SUSTAIN™ 1 – Monotherapy
    SUSTAIN™ 1 – Monoterapia
    A.4.1Sponsor's protocol code numberNN9535-3623
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1139-3090
    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 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 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 AddressVandtårnsvej 114, VTB
    B.5.3.2Town/ citySøborg
    B.5.3.3Post codeDK-2860
    B.5.3.4CountryDenmark
    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 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 nameSemaglutide B 1.34 mg/ml PDS290
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    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 INNSEMAGLUTIDE
    D.3.9.1CAS number 910463-68-2
    D.3.9.4EV Substance CodeSUB31671
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.34
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 in pre-filled pen
    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
    Diabetes Mellitus, Type 2
    diabete mellito, tipo 2.
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    diabete mellito, tipo 2.
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of once-weekly dosing of two dose levels of semaglutide versus placebo on glycaemic control after 30 weeks of treatment in drug-naïve subjects with type 2 diabetes
    Dimostrare la superiorità di due diversi dosaggi di semaglutide somministrata una volta la settimana rispetto al placebo sul controllo glicemico dopo 30 settimane di trattamento in pazienti con diabete di tipo 2 mai trattati.
    E.2.2Secondary objectives of the trial
    To compare the effects of once-weekly dosing of two dose levels of semaglutide versus placebo after 30 weeks of treatment on:
    - Inducing and maintaining weight loss
    - Other parameters of efficacy, safety and tolerability
    Confrontare gli effetti della somministrazione una volta a settimana dei due diversi dosaggi di semaglutide rispetto al placebo dopo 30 settimane di trattamento sui seguenti parametri:
    - Induzione e mantenimento della perdita di peso corporeo
    - Altri parametri di efficacia, sicurezza e tollerabilità
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, age equal to or above 18 years at the time of signing informed consent
    2. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent
    3. Subjects diagnosed with type 2 diabetes and treated with diet and exercise for at least 30 days before screening
    4. HbA1c 7.0 – 10.0 % (53 - 86 mmol/mol) (both inclusive)
    1. Uomini e donne di età ≥ 18 anni al momento della firma del consenso informato.
    2. Solo per il Giappone: Uomini e donne di età ≥ 20 anni al momento della firma del consenso
    informato.
    3. Pazienti con diagnosi di diabete di tipo 2 in trattamento con dieta ed esercizio fisico per
    almeno 30 giorni prima dello screening.
    4. HbA1c 7,0 – 10,0 % (53 - 86 mmol/mol) (entrambi compresi).
    E.4Principal exclusion criteria
    1. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
    2. Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject’s safety or compliance with the protocol
    3. Treatment with any glucose lowering agent(s) in a period of 90 days prior to screening. An exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with inter-current illness
    4. History of chronic or idiopathic acute pancreatitis
    5. Screening calcitonin value equal to or above 50 ng/L (pg/mL)
    6. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2)
    7. Impaired renal function defined as eGFR below 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
    8. Acute coronary or cerebrovascular event within 90 days before randomisation
    9. Heart failure, New York Heart Association class IV
    1. Donne in età fertile in stato di gravidanza, in allattamento al seno, che stiano pianificando
    una gravidanza o che non utilizzino adeguati metodi contraccettivi (metodi di contraccezione adeguati secondo quanto previsto dalle leggi vigenti o dalle procedure locali) per tutta la durata dello studio, comprese le 5 settimane del periodo di controllo
    (follow-up).
    2. Malattie croniche o gravi patologie che, secondo il medico sperimentatore, potrebbero mettere a rischio la sicurezza del paziente, l’aderenza (compliance) al protocollo.
    3.Trattamento con agenti ipoglicemizzanti nei 90 giorni precedenti lo screening. Eccezione fatta per il trattamento a breve termine (≤ 7 giorni ) con insulina per il trattamento di una malattia intercorrente.
    4. Storia di pancreatite cronica o pancreatite acuta idiopatica.
    5. Valori di calcitonina allo screening ≥ 50 ng/L (pg/mL).
    6. Storia personale o familiare di carcinoma midollare della tiroide (MTC) o neoplasia endocrina multipla di tipo 2 (MEN 2).
    7. Funzione renale ridotta definita come stima della filtrazione glomerulare (eGFR) < 30
    mL/min/1.73 m2, secondo la formula MDRD (versione a 4 variabili).
    8. Eventi acuti coronarici o cerebrovascolari verificatisi nei 90 giorni precedenti la randomizzazione.
    9. Insufficienza cardiaca, classe IV NYHA (New York Heart Association).
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c
    Variazione del valore di HbA1c
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 30
    rispetto al valore basale dopo 30 settimane di trattamento
    E.5.2Secondary end point(s)
    Change in
    1. Body weight
    2. Fasting plasma glucose
    3. Systolic and diastolic blood pressure

    Subjects who achieve (yes/no):
    4. HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target
    5. HbA1c equal to or below 6.5% (48 mmol/mol) American Association of Clinical Endocrinologists target
    Variazione dei seguenti valori basali:
    1. peso
    2. glicemia a digiuno
    3. Pressione arteriosa sistolica e diastolica
    Pazienti che conseguono o meno i seguenti valori:
    4. HbA1c <7,0% (53 mmol/mol), target stabilito dalla American Diabetes Association
    5. HbA1c ≤6,5% (48 mmol/mol), target stabilito dalla American Association of Clinical
    Endocrinologists
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. + 2. + 3.: From baseline to week 30
    4. + 5.: After 30 weeks' treatment
    1. + 2. + 3.: fino alla trentesima settimana a partire dalla baseline
    4. + 5.: Dopo 30 settimane di trattamento
    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
    Tollerabilità
    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 trial4
    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 EEA30
    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 No
    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
    European Union
    Japan
    Mexico
    Russian Federation
    South Africa
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LSLV
    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 days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days14
    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: 312
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 78
    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 90
    F.4.2.2In the whole clinical trial 390
    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)
    N/A
    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 Decision2013-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-13
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