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    Summary
    EudraCT Number:2012-005399-32
    Sponsor's Protocol Code Number:DPP-IVEPC
    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:2013-01-11
    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 number2012-005399-32
    A.3Full title of the trial
    Randomized, open label, two parallel arms, intervention trial comparing the effect of DPP-IV inhibitor Vildagliptin vs. Glibenclamide on circulating EPCs.
    Trial di intervento monocentrico, randomizzato, in aperto, a 2 bracci paralleli per valutare l'effetto dell'inibitore della DPP-IV Vildagliptin vs. Glibenclamide nella modulazione delle EPCs circolanti.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intervention trial comparing the effect of DPP-Iv inhibitor Vildagliptin vs. Glibenclamide on circulating EPCs.
    Trial di intervento per valutare l’effetto dell’inibitore della DPP-IV Vildagliptin vs. Glibenclamide nella modulazione delle EPCs circolanti.
    A.3.2Name or abbreviated title of the trial where available
    Vildagliptin and EPC
    Vildagliptin ed EPC
    A.4.1Sponsor's protocol code numberDPP-IVEPC
    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 DI PARMA
    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 supportDipartimento di Medicina Clinica e Sperimentale dell'Università di Parma
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSegreteria Scientifica Comitato Etico
    B.5.2Functional name of contact pointComitato Etico Unico
    B.5.3 Address:
    B.5.3.1Street AddressVia Gramsci 14
    B.5.3.2Town/ cityParma
    B.5.3.3Post code43126
    B.5.3.4CountryItaly
    B.5.4Telephone number0521704775
    B.5.5Fax number0521704702
    B.5.6E-mailgideluca@ao.pr.it
    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 GALVUS*56CPR 50MG
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.8INN - Proposed INNVILDAGLIPTIN
    D.3.9.1CAS number 274901-16-5
    D.3.9.4EV Substance CodeSUB25199
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.2.1.1.1Trade name EUGLUCON*30CPR 5MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.8INN - Proposed INNGLIBENCLAMIDE
    D.3.9.1CAS number 10238-21-8
    D.3.9.4EV Substance CodeSUB07916MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    type 2 diabetes mellitus
    diabetici tipo 2 Diabete Mellito
    E.1.1.1Medical condition in easily understood language
    type 2 diabetes mellitus
    diabetici tipo 2 Diabete Mellito
    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 10012614
    E.1.2Term Diabetes mellitus NOS
    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 evaluate the effect of DPP-IV inhibitor Vildagliptin vs. Glibenclamide on circulating EPCs.
    Valutare l’effetto dell’inibitore della DPP-IV Vildagliptin nella mobilitazione delle EPCs circolanti confrontato con Glibenclamide.
    E.2.2Secondary objectives of the trial
    Absolute and relative change in HbA1C at visit V2, V3, V4.
    Cambiamento assoluto e percentuale dei valori di HbA1c alla V2, V3, V4 rispetto alla visita di randomizzazione
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age equal or above 35 years;
    2. Diagnosis of type 2 diabetes mellitus as defined by the American Diabetes Association , with at least one year of disease duration at the time of the screening visit;
    3. Blood glucose lowering treatment with Metformin alone (monotherapy) at a stable dose of at least 1.5 g/day (or maximum tolerated dose) in the 3 months prior to the screening visit;
    4. Insufficient metabolic control as defined by recent (last six months) HbA1c ≥ 7% in any peripheral laboratory and confirmed at the time of the screening;
    5. Absence of a recent clinically-relevant progression of micro- and macro-vascular complications (see exclusion criteria);
    6. Written informed consent to participate to the study.
    1. Età ≥ 35 anni;
    2. Diagnosi di diabete mellito di tipo 2 secondo la definizione dell’American Diabetes Association [Diabetes Care. 2006;29 Suppl 1:S4-42] da almeno un anno;
    3. Terapia ipoglicemizzante con sola Metformina a dose stabile di almeno 1.5 gr/d o massimo tollerato nei 3 mesi precedenti lo screening;
    4. HbA1c ≥ 7%;
    5. Assenza di progressione clinicamente rilevante di micro- o macro-angiopatia nei 6 mesi precedenti lo screening;
    6. Consenso informato scritto a partecipare allo studio.
    E.4Principal exclusion criteria
    1. Age below 35 years
    2. Type 1 diabetes or other causes of diabetes (pancreatectomy, gestational diabetes, etc.)
    3. HbA1c < 7% or ≥ 9% at the screening visit
    4. Treatment with any blood glucose lowering treatment other than Metformin in the six months before screening visit
    5. BMI < 20 or ≥ 40 kg/m2, or current/ past history of clinically-relevant eating disorders (including -but no limited to- nervous anorexia, bulimia, binge-eating disorders, etc.)
    6. Significant progression of diabetic macro-angiopathy or cardiovascular disease in the six months prior to study visit, including:
    - Acute myocardial infarction or acute coronary syndrome requiring hospitalization;
    - Acute cerebro-vascular event requiring hospitalization;
    - Acute limb ischemia or new onset of clinically-relevant peripheral artery disease (as defined by claudication + positive ABI test);
    - New limb ulceration of suspected vascular origin or new onset of a diabetic foot or significant progression of pre-existing lesions;
    - Any revascularization procedure (by-pass, stenting, angioplasty, trombo-endarterectomy, etc.) in any arterial district;
    7. Significant progression of diabetic micro-angiopathy in the six months prior to study visit, including:
    - Proliferative retinopathy, or progression of severity of more than one step, or new macular edema likely to be laser-treated. Steps of diabetic retinopathy: absent, background, mild non-proliferative, moderate-to-severe non-proliferative, proliferative;
    - Increase of at least 0.5 mg/dL of plasma creatinine or progression to macro-proteinuria;
    - Onset of clinically-relevant neuropathy
    - Onset of erectile dysfunction
    8. Organ failure or other severe diseases limiting life expectancy;
    9. Beginning, in the three months before screening visit, of any kind of drug which can modify glicemic levels (beta-blockers, diuretics…), or acute disease (acute infection, urinary tract infection…) in three months before screening visit
    10. History of inflammatory/infective/autoimmune chronic disease
    11. History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, gastric surgery, inflammatory bowel disease;
    12. Any clinically significant abnormality identified on physical examination, laboratory tests, ECG or vital signs at screening that in the judgment of the investigator would preclude safe completion of the study;
    13. Uncontrolled or inadequately controlled hypertension at screening (SBP>190 or DBP >100 mmHg)
    14. Ongoing pregnancy or absence of effective contraception in women with childbearing potential
    15. Contraindications to the maintenance of the background therapy (Metformin), including –but not limited to- chronic kidney failure or plasma creatinine concentrations > 1.5 mg/dL, severe respiratory failure, etc.;
    16. Contraindications to the use of a Sulfonylurea;
    17. Contraindications to the use of a DPP-IV Inhibitor;
    18. Laboratory findings, or other disease conditions, at the screening visit that might interfere with study measurements:
    - Hemoglobinopathy known to affect HbA1c assays;
    - Known chronic liver diseases, including HBV and HCV infection;
    - Liver makers (AST, ALT, ALP, GGT, bilirubin) above 2 times the upper normal limit;
    - Amylase and/or lipase above 2 times the upper normal limit;
    19. Chronic use of systemic and/or inhaled corticosteroids (only topical corticosteroids are allowed);
    20. History of low compliance, clinically-relevant psychiatric disorders or any current/ historical finding suggesting the patient as inappropriate to follow the study procedures.
    1. Età &lt; 35 anni;
    2. Diabete tipo 1 o altro tipo diverso da diabete tipo 2 (LADA, gestazionale, post-pancreasectomia, ecc.);
    3. HbA1c &lt; 7% o ≥ 9% alla visita di screening;
    4. Terapia con ipoglicemizzanti orali diversi da Metformina nei 6 mesi precedenti la visita di screening;
    5. BMI &lt; 20 o ≥ 40 kg/m2 (o precedente storia di disturbo del comportamento alimentare clinicamente rilevante);
    6. Significativa progressione delle complicanze macro-angiopatiche o malattie cardiovascolari nei sei mesi precedenti l’inizio dello studio:
    - Infarto miocardio acuto o sindrome coronarica acuta che ha richiesto l’ospedalizzazione
    - Evento cerebrovascolare acuto che ha richiesto l’ospedalizzazione
    - Ischemia acuta degli arti inferiori o arteriopatia obliterante periferica di nuova diagnosi (definita da presenza di claudicatio e positività del test ABI)
    - Ulcerazioni agli arti inferiori di sospetta origine vascolare di nuova diagnosi o piede diabetico di nuova diagnosi o significativa progressione di lesioni preesistenti
    - Interventi di rivascolarizzazione in qualsiasi distretto arterioso (by-pass, stenting, angioplastica, tromboendoarteriectomia, ecc.);
    7. Significativa progressione delle complicanze micro-angiopatiche nei sei mesi precedenti l’inizio dello studio:
    - Retinopatia proliferante, o progressione della severità della retinopatia superiore ad un singolo step, o edema maculare di nuova diagnosi che necessita di trattamento laser. Steps della retinopatia diabetica: assente, background, non proliferante lieve, non proliferante moderata-severa, proliferante.
    - Incremento di almeno 0,5 mg/dL della creatinina plasmatica o progressione verso la macroalbuminuria;
    - Insorgenza di neuropatia clinicamente rilevante;
    - Insorgenza di disfunzione erettile;
    8. Insufficienza d’organo o altre patologie di rilievo che limitino l’aspettativa di vita;
    9. Assunzione di farmaci in grado di modificare i livelli glicemici (beta-bloccanti, diuretici...) o patologie acute (malattie infettive acute, infezione delle vie urinarie...) nei tre mesi precedenti la visita di screening;
    10. Storia di malattie croniche di tipo infiammatorio/infettivo/autoimmune;
    11. Storia di pancreatite ad eziologia sconosciuta, pancreatite cronica, pancreasectomia, chirurgia gastrica, malattie infiammatorie croniche intestinali;
    12. Qualsiasi anomalia clinicamente significativa riscontrata durante la valutazione di esame obiettivo, esami di laboratorio, ECG o segni vitali alla visita di screening che a giudizio dello sperimentatore possa precludere la sicurezza del paziente durante tutta la durata dello studio;
    13. Ipertensione non controllata o controllata in maniera inadeguata alla visita di screening (PAS &gt;190 mmHg o PAD &gt; 100 mmHg)
    14. Gravidanza o assenza di contraccezione sicura nelle donne in età fertile;
    15. Controindicazioni al mantenimento della terapia con Metformina, incluso insufficienza renale cronica o creatininemia &gt;1,5 mg/dL, severa insufficienza respiratoria, ecc.;
    16. Controindicazioni all’uso delle Sulfaniluree;
    17. Controindicazioni all’uso degli inibitori della DPP-IV;
    18. Condizioni individuate alla visita di screening che possano interferire con le misurazioni dello studio:
    - Emoglobinopatie tali da alterare i valori di HbA1c;
    - Patologie epatiche croniche, incluso infezione da HBV e HCV;
    -Marcatori epatici (AST, ALT, ALP, GGT, bilirubina) superiore di 2 volte il limite massimo normale;
    - Amilasi e/o lipasi superiore di 2 volte il limite massimo normale;
    19. Terapia cronica con corticosteroidi per via sistemica o inalatoria (solamente i corticosteroidi topici sono ammessi);
    20. Storia di ridotta compliance o patologia psichiatrica rilevante o qualsiasi altra condizione che renda il paziente inappropriato per lo studio
    E.5 End points
    E.5.1Primary end point(s)
    Absolute and relative change in the EPC number at visit: V0 (randomization), V2 (month 4), V3 (month 8) and V4 (month 12).
    Cambiamento assoluto e percentuale del numero di EPC alla V0, V2 (mese 4), V3 (mese 8) e V4 (mese 12).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    Absolute and relative change in HbA1C at visit V2, V3, V4.
    Cambiamento assoluto e percentuale dei valori di HbA1c alla V2, V3, V4 rispetto alla visita di randomizzazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    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 Yes
    E.6.13.1Other scope of the trial description
    To evaluate the effect of DPP-IV inhibitor Vildagliptin vs. Glibenclamide on circulating EPCs
    Valutare l’effetto dell’inibitore della DPP-IV Vildagliptin nella mobilitazione delle EPC circolanti
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    LVLS
    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 months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    E.8.9.2In all countries concerned by the trial 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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    PATIENTS WILL BE FOLLOWING IN USUAL CARE
    I PAZIENTI PROSEGUONO CON L'USUAL CARE
    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 Decision2013-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-10
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