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    Summary
    EudraCT Number:2011-003335-63
    Sponsor's Protocol Code Number:LIRA-B-CELL
    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:2012-06-20
    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 number2011-003335-63
    A.3Full title of the trial
    Effects of liraglutide on β-cell function in type 2 diabetic patients with secondary failure to oral hypoglycemic agents. A randomized, controlled, parallel groups, open-label, phase II study.
    Effetti di liraglutide sulla funzione cellulare nei pazienti con diabete tipo 2 in fallimento secondario agli ipoglicemizzanti orali. Studio di fase II, randomizzato, controllato, a gruppi paralleli, in aperto.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of liraglutide on pancreatic function in type 2 diabetic patients with secondary failure to oral hypoglycemic agents.
    Effetti di liraglutide sulla funzione pancreatica nei pazienti con diabete tipo 2 in fallimento secondario agli ipoglicemizzanti orali.
    A.4.1Sponsor's protocol code numberLIRA-B-CELL
    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 OSPEDALIERO-UNIVERSITARIA PISANA
    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 supportUNIVERSITA' DI PISA
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportNOVO NORDISK
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNIVERSITA' DI PISA
    B.5.2Functional name of contact pointU.O. DIABETOLOGIA E MAL.METABOLICHE
    B.5.3 Address:
    B.5.3.1Street AddressVIA PARADISA 2
    B.5.3.2Town/ cityPISA
    B.5.3.3Post code56124
    B.5.3.4CountryItaly
    B.5.4Telephone number+39050995103
    B.5.5Fax number+39050541521
    B.5.6E-mailstefano.delprato@med.unipi.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 VICTOZA*SC 2PEN 3ML 6MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderNOVO NORDISK FARMACEUTICI 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 Solution for injection
    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 INNLIRAGLUTIDE
    D.3.9.1CAS number 204656-20-2
    D.3.9.4EV Substance CodeSUB25238
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Yes
    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.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 GLIMEPIRIDE TEVA*20CPR 4MG
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA Srl
    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 INNGLIMEPIRIDE
    D.3.9.1CAS number 93479971
    D.3.9.4EV Substance CodeSUB07925MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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: 3
    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 LEVEMIR*FLEX 5PEN 3ML 100UI/ML
    D.2.1.1.2Name of the Marketing Authorisation holderNOVO NORDISK FARMACEUTICI 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 Solution for injection
    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 INNINSULIN DETEMIR
    D.3.9.1CAS number 169148-63-4
    D.3.9.4EV Substance CodeSUB02692MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Yes
    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.IMP: 4
    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 METFORMINA TEVA IT*60CPR RIV1G
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA Srl
    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 Coated 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 INNMETFORMIN
    D.3.9.1CAS number 657-24-9
    D.3.9.4EV Substance CodeSUB08831MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Diabete mellito tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes
    Diabete tipo 2
    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 10012613
    E.1.2Term Diabetes mellitus non-insulin-dependent
    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 determine to which extent liraglutide can maintain β-cell function in type 2 diabetic patients with secondary failure after an adequate period of good glycaemic control.
    Determinare in che misura liraglutide può mantenere la funzione β-cellulare nei pazienti con diabete tipo 2 in fallimento secondario dopo un adeguato periodo di controllo glicemico.
    E.2.2Secondary objectives of the trial
    To compare the effects of liraglutide and sulphonylurea on glicaemic control (fasting plasma glucose, HbA1C).
    Confrontare gli effetti di liraglutide e sulfonilurea sul mantenimento del controllo glicemico (glicemia a digiuno,HbA1C).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The subject must give signed informed consents before any trial-related activities. • Type 2 diabetic subjects • Age >30 years and <75 years old • HbA1c ≥8.0 and <= 9.5% • Fasting plasma glucose <= 140 mg/dl • BMI >25 Kg/m2 and <40 Kg/m2 • Currently treated with metformin and sulphnilurea • Ability to comply with the study protocol
    • Firma del consenso informato • Diabete mellito tipo 2 • Età &gt;30 anni e &lt;75 anni • HbA1c ≥8.0 e &lt;= 9.5% • Glicemia a digiuno &lt;= 140 mg/dl • BMI &gt;25 Kg/m2 e &lt;40 Kg/m2 • In trattamento con la massima dose tollerata di sulfonilurea e metformina • Capacità e possibilità di seguire e completare lo studio
    E.4Principal exclusion criteria
    • Participation in any other clinical trial three month prior to trial entry • Pregnancy, breastfeeding or women of childbearing age who do not follow adequate contraception • Patients has taken other antidiabetic drugs in the three month prior to trial entry • Current systemic treatment with concomitant medication having a significant influence on an end-point e.g. corticosteroids, thiazides, β-blockers or ACE-inhibitors. • Known or suspected history of drug or alcohol dependence. • Any other significant concomitant disease such as cardiovascular (heart failure, angina pectoris, recent (within the last 12 months) myocardial infarction) or symptomatic peripheral vascular disease, malignant, hepatic disease (ALT>2 times upper limit of normal), renal impairment (serum creatinine >1.5 mg/dl). • Known or suspected allergy to trial products • BMI ≤25 Kg/m2 or ≥40 Kg/m2 • Mental incapacity • Any disease or condition which the investigator feels would interfere with the trial
    • Partecipazione ad altri studi clinici nei tre mesi precedenti • Donne in gravidanza, allattamento o in età fertile che non seguono adeguata contraccezione • Uso di altri farmaci ipoglicemizzanti orali nei 3 mesi precedenti la visita di screening • Trattamento concomitante con farmaci con significativa influenza sul metabolismo glucidico e sulla funzione β-cellulare, ad esempio corticosteroidi, tiazidici, β-bloccanti, ACE-inibitori • Storia o dipendenza attuale da droghe o alcolici • Ogni altra patologia concomitante come patologie cardiovascolari (insufficienza cardiaca, angina pectoris, recente (negli ultimi 12 mesi) infarto del miocardio) o neoplasie, malattie epatiche (ALT &gt;2 volte il limite alto di normalità), insufficienza renale (creatinina sierica &gt;1.5 mg/dl). • Allergia nota o sospetta ai farmaci in studio • BMI ≤25 Kg/m2 o ≥40 Kg/m2 • Incapacità mentale • Ogni altra condizione o malattia che secondo lo sperimentatore può interferire con lo studio.
    E.5 End points
    E.5.1Primary end point(s)
    β-cell glucose sensitivity as derived from the OGTT test analyzed according to Mari et al.
    Sensibilità β-cellulare al glucosio derivata dall’analisi dell’OGTT secondo Mari et al.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 64 and 66 weeks
    64 e 66 settimane
    E.5.2Secondary end point(s)
    parameters of glycaemic control (FPG, HbA1C), time of loss of glycaemic control after stopping insulin treatment and proxies of beta-cell function i.e. Rate sensitivity (referring to the magnitude of beta-cell to respond to changes in prevailing plasma glucose concentrations), Potentiation factor, Dose response Insulin Secretion Rate and HOMA-B
    parametri del controllo glicemico (glicemia a digiuno, HbA1C), tempo di perdita del controllo glicemico dopo la sospensione del trattamento insulinico e recupero della funzione β-cellulare, cioè tasso di sensibilità (ampiezza della risposta β-cellulare per fronteggiare i cambiamenti nelle concentrazioni plasmatiche di glucosio), fattore di potenziamento, tasso dose-risposta della secrezione insulinca e HOMA-B.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 64 and 66 weeks
    64 e 66 settimane
    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 No
    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
    physiopathology
    fisiopatologia
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 months23
    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.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state80
    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)
    After completion of the study patients will return to their usual treatment as deemed appropriate by the investigators.
    Al termine dello studio i pazienti torneranno al loro trattamento usuale secondo giudizio dello sperimentatore.
    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 Decision2012-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-07
    P. End of Trial
    P.End of Trial StatusOngoing
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