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   43875   clinical trials with a EudraCT protocol, of which   7295   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

    Summary
    EudraCT Number:2010-019346-11
    Sponsor's Protocol Code Number:2010-019346-11
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-12-27
    Trial 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 number2010-019346-11
    A.3Full title of the trial
    Effects of vildagliptin twice daily vs. sitagliptin once daily on reduction of oxidative stress and inflammation by blunting interprandial acute glucose fluctuations in patients with type 2 diabetes - PROBE Design (Multicenter Prospective, Randomized, Open-label parallel group with a blinded-endpoint)
    Effetti di vildagliptin(50 mg x 2/die) vs sitagliptin (100 mg/die) sullo stress ossidativo e sull'infiammazione in relazione alle fluttuazioni glicemiche interprandiali in pazienti con diabete mellito tipo 2 - PROBE Design (Multicenter Prospective, Randomized, Open-label parallel group with a blinded-endpoint)
    A.4.1Sponsor's protocol code number2010-019346-11
    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 SponsorAZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA' DEGLI STUDI DI NAPOLI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    patients with type 2 diabetes poorly controlled
    PAZIENTI DIABETICI SCOMPENSATI
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10063624
    E.1.2Term Type II diabetes mellitus inadequate control
    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 compare the respective effects of vildagliptin and sitagliptin, as a regulation strategy attempting to stabilize glucose excursions over 24 hours, on oxidative stress and proinflammatory cytokines implicated in the atherosclerotic process, in patients with type 2 diabetes poorly controlled with metformin therapy.
    Valutare gli effetti del vildagliptin e del sitagliptin sia sullo stress di ossidativo che sullo stato infiammatorie, in pazienti con diabete tipo 2, in scarso controllo metabolico con metformina, in base alle escursioni glicemiche giornaliere
    E.2.2Secondary objectives of the trial
    none
    nessuno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. type 2 diabetic patients on metformin therapy without adequate glycemic control (within 3 months) (HbA1c >7.5%) while on hypocaloric diet regiment for almost three months. 2. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. 3. Female patients who are receiving nonyclical hormone therapy (including non cyclical hormone replacement therapy or any estrogen antagonist/agonist) have been maintained on a stable dose and regimen for at least 8 weeks prior to Visit 1 and patient is willing to continue the same regimen throughout the study.
    1. Pazienti di eta' compresa tra 18 e 75 anni, con diabete tipo 2 in terapia con metformina in inadeguato compenso glicemico (HbA1c &gt;7.5% negli ultimi 3 mesi) in regime dietetico ipocalorico da almeno 12 settimane. 2. Negativita' al dosaggio di &#946;-Hcg per le pazienti di sesso femminile in eta' fertile, mentre se in menopausa e in terapia ormonale sostitutiva, le pazienti dovranno aver mantenuto la dose stabile di terapia ormonale almeno nelle 8 settimane precedenti la Visita 1 e continuarla con la stessa posologia per l?intero studio. 3. Firma, da parte dei pazienti, del consenso informato scritto per la partecipazione allo studio, dopo essere stati adeguatamente eruditi su tutte le procedure, per partecipare allo studio
    E.4Principal exclusion criteria
    1. BMI >35 kg/m2. 2. Patient having hypersensitivity or intolerance to vildagliptin and sitagliptin or any component of these medications. 3. Patient routinely consuming more than 3 alcoholic drinks per day. 4. Patient currently participating in a study with an investigational compound 5. Patient's glycemia are >300 mg/dL at Visit 2. 6. Patient with uncontrolled endocrine or metabolic disease known to influence glycemia (i.e., secondary causes of hyperglycemia). 7. Patient with NYHA class III /IV 8.Unstable Angina pectoris, with precedent history of heart attack and bypass or angioplastica or severe peripheral arteriopatia. 9. ileale bypass partial , gastric bypass or intestinal illness 10. hypertension , with systolic PA > 160 mm Hg or diastolic > 100 mm Hg to the visit 1. 11. Presence of filtrate glomerulare (eGFR) < 30 mL / min /1.73 m2s, with syndrome nefrosica or other renal illnesses. 12. Hematological pathologies. 13. Cerebrovascular pathologies, included the cognitive deficits e/o psychiatric pathologies that limit the ability to participate in the study. 14. Positiveness to the HIV. 15. neoplasie History in the 5 preceding years to the date of the informed consent. 16. illegitimate drugs use or recent history of alcoholism in the last year. 17. Use of the citocrome P450 3A4 (CYP3A4)inhibitors. 18. Use of ciclosporine, danazolo or sour fusidico 19. Treatment with corticosteroidi (ev or im) 20. Treatment with Orlistat or sibutramine 21. Treatment with warfarin
    1. BMI &gt;35 kg/m2 2. Ipersensibilita' o intolleranza al vildagliptin e al sitagliptin 3. Consumo routinario di piu' di 3 bevande alcoliche/die. 4. Partecipazione contemporanea ad altri protocolli di studio. 5. Valori glicemici &gt;300 mg/dl alla visita 2. 6. Presenza di malattie endocrine e metaboliche note che possano influenzare i valori glicemici (causa di iperglicemia secondaria, quali m. di Cushing). 7. Insufficienza cardiaca, secondo i criteri NYHA (New York Heart Association), in classe III o IV. 8. Angina pectoris instabile, con precedente storia di infarto del miocardio e/o bypass aortocoronarico o ad angioplastica, o arteriopatia periferica severa. 9. Bypass ileale parziale, bypass gastrico o malattia intestinale con malassorbimento. 10. Ipertensione arteriosa non controllata, con PA sistolica &gt;160 mm Hg o diastolica &gt;100 mm Hg alla visita 1. 11. Presenza di filtrato glomerulare (eGFR) &lt;30 mL/min/1.73 m2 , con syndrome nefrosica o altre malattie renali. 12. Patologie ematologiche. 13. Patologie cerebrovascolari, inclusi i deficit cognitivi e/o patologie psichiatriche che limitino la capacita' di intendere e di scegliere di partecipare allo studio. 14. Positivita' nota all?HIV. 15. Storia di cancro nei 5 anni precedenti alla data del consenso informato. 16. Uso illecito di droghe o storia recente di alcolismo nell?ultimo anno. 17. Uso di inibitori del citocromo P450 3A4 (CYP3A4). 18. Uso di ciclosporine, danazolo o acido fusidico 19. Trattamento con corticosteroidi (ev o im) o somministrazione di corticostroidi nelle 6 settimane precedenti la randomizzazione. 20. Trattamento con orlistat, sibutramina, o altra terapia anti-obesita'. 21. Trattamento con warfarin se non in compenso stabile (International Normalized Ratio - INR) per 6 settimane prima della visita 1.
    E.5 End points
    E.5.1Primary end point(s)
    nitrotyrosine and proinflammatory cytokines reduction
    riduzione della nitrotirosina e delle citochine infiammatorie
    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 No
    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.8.2.4Number 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 concerned2
    E.8.5The trial involves multiple Member States No
    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 No
    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 months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=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 2011-12-27. 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 state90
    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 Decision2010-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-03
    P. End of Trial
    P.End of Trial StatusOngoing
    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-Fri May 17 13:41:06 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA