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    Summary
    EudraCT Number:2012-003626-24
    Sponsor's Protocol Code Number:MK-3102-011
    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 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 number2012-003626-24
    A.3Full title of the trial
    A Multicenter, Phase III, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of MK-3102 Monotherapy in Subjects with Type 2 Diabetes Mellitus and Inadequate Glycemic Control
    Uno Studio multicentrico di fase III, randomizzato, controllato verso placebo per valutare la sicurezza e l™efficacia di MK-3102 in monoterapia in soggetti con diabete mellito di tipo 2 e controllo glicemico inadeguato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 study in Patients with Type 2 Diabetes Mellitus
    Studio di fase III su pazienti affetti da diabete mellito di tipo 2
    A.4.1Sponsor's protocol code numberMK-3102-011
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 732 594 2622
    B.5.5Fax number+1 732-594-3560
    B.5.6E-mailira_gantz@merck.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 nameMK-3102
    D.3.2Product code MK-3102
    D.3.4Pharmaceutical form Capsule
    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 INNOmarigliptin
    D.3.9.2Current sponsor codeMK-3102
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Metformin
    D.2.1.1.2Name of the Marketing Authorisation holderAurobindo Pharma USA, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 INNMETFORMIN
    D.3.9.1CAS number 657-24-9
    D.3.9.4EV Substance CodeSUB08831MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    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 di tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes Mellitus is a metabolic disorder that is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency.
    Il diabete mellito di tipo2 è una malattia metabolica caratterizzata da un alto livello di glucosio nel sangue in un contesto di resistenza all insulina e di deficienza relativa di insulina
    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 14.1
    E.1.2Level HLT
    E.1.2Classification code 10012602
    E.1.2Term Diabetes mellitus (incl subtypes)
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    After 24 weeks, to assess the effect of treatment with MK-3102 compared with placebo on A1C. To assess the safety and tolerability of MK-3102.
    Valutare l’effetto sulla A1C del trattamento con MK-3102 rispetto a placebo dopo 24 settimane. Valutare la sicurezza e la tollerabilità di MK-3102.
    E.2.2Secondary objectives of the trial
    (1) After 24 weeks, to assess the effect of treatment with MK-3102 compared with placebo on 2-hour Post-Meal Glucose (PMG). (2) After 24 weeks, to assess the effect of treatment with MK-3102 compared with placebo on FPG. (3) Objective: After 54 weeks, to assess the effect of treatment with MK- 3102 on A1C, 2-hour PMG, and FPG. (4) Objective: After 24 weeks, and after 54 weeks, to assess the effect of treatment with MK-3102 on proportion of subjects achieving an A1C goal (<6.5%, <7.0%).
    (1) Obiettivo: dopo 24 settimane, valutare l’effetto del trattamento con MK-3102 rispetto a placebo sulla glicemia postprandiale (PMG) a 2 ore. (2) Obiettivo: valutare l’effetto del trattamento con MK-3102 rispetto a placebo sulla FPG dopo 24 settimane. (3) Obiettivo: valutare l’effetto del trattamento con MK-3102 sulla A1C, sulla PMG a 2 ore e sulla FPG dopo 54 settimane. (4) Obiettivo: valutare l’effetto del trattamento con MK-3102 sulla percentuale di soggetti che raggiungono un obiettivo A1C (&lt;6,5%, &lt;7,0%) dopo 24 e 54 settimane.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has T2DM and must be ≥18 years of age on the day of signing the informed consent form. 2. Subject meets one of the following criteria: a. Subject is currently not on an AHA (off AHA therapies for ≥12 weeks) and has a Visit 1/Screening Visit A1C ≥7.0 and ≤10.0%. b. Subject is currently on a stable dose for > 12 weeks of a single AHA or low-dose dual oral AHA combination therapy (i.e., ≤50% maximum labeled dose of each agent [except thiazolidinediones (TZDs)]) and has a Visit 1/ Screening Visit A1C ≥6.5 and ≤9.0% AND based upon review of the subject's current diet, medical regimen, and Visit 1 A1C, subject is considered by the investigator to be likely to meet Visit 3/Week -2 inclusion criterion of A1C ≥7.0 and ≤ 10.0% AFTER the 8-week wash-off period prior to Visit 3/Week-2 (Visit 2/Week -10 to Visit 3/ Week -2). 3. Subject meets one of the following criteria: a. Subject is a male b. Subject is a female not of reproductive potential defined as one who has either • reached natural menopause (defined as ≥12 months of spontaneous amenorrhea in women >45 years of age, or ≥6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the laboratory), or • had bilateral oophorectomy and/or hysterectomy, or had bilateral tubal ligation at least 6 weeks prior to screening c. Subject is a female of reproductive potential and agrees to: • remain abstinent from heterosexual activity (this form of birth control must be accepted by local regulatory agencies and review committees as the sole method of birth control), or • use (or have their partner use) adequate contraception to prevent pregnancy within the projected duration of the trial and for 21 days after the last dose of trial medication. Adequate methods of contraception include: - use of 2 barrier methods. Acceptable barrier methods are: diaphragm with spermicide, cervical cap, contraceptive sponge, condom - use of an IUD and one of the barrier methods identified above - vasectomy in a male partner and use of one of the barrier methods identified above 4. Subject understands the trial procedures, alternative treatments available, and risks involved with the trial, and voluntarily agrees to participate by giving written informed consent. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research. 5. Subject has an A1C of ≥7.0% and ≤10.0% within 2 weeks of Visit 3/Week -2. Note: If the A1C is not within the Visit 3 A1C inclusion criterion, a single repeat measurement maybe performed at the discretion of the investigator. If repeat value meets Visit 3 A1C inclusion criterion, subject may continue in the trial. 6. Subject has 100% compliance with MK-3102 placebo treatment during the single-blind run-in period (as determined by site-performed capsule count).
    1. Il soggetto ha T2DM ed età ≥18 anni nel giorno della firma del modulo di consenso informato. 2. Il soggetto soddisfa uno dei criteri seguenti: a. non è attualmente in terapia con un AHA (terapie AHA sospese da &gt;=12 settimane) e A1C &gt;=7,0% e &lt;=10,0% alla Visita 1/Screening; b. è attualmente in trattamento con una dose stabile da &gt;12 settimane di un AHA o in terapia combinata a base di due AHA per via orale a basso dosaggio (ovvero al &lt;=50% della dose massima indicata per ciascun agente [eccetto tiazolidinedioni (TDZ)] e A1C &gt;=6,5% e &lt;=9,0% alla Visita 1/Screening E, in base all’esame del regime alimentare corrente, del regime terapeutico e alla A1C alla Visita 1, lo sperimentatore ritiene sia probabile che il soggetto soddisfi il criterio di inclusione della Visita 3/Settimana -2, ovvero A1C &gt;=7,0% e &lt;=10,0% DOPO il periodo di wash-out di 8 settimane precedente la Visita 3/Settimana -2 (dalla Visita 2/Settimana -10 alla Visita 3/Settimana -2). 3. Il soggetto soddisfa uno dei criteri seguenti: a. è di sesso maschile; b. è di sesso femminile non in età fertile, definito come una donna che: • ha raggiunto la menopausa naturale (definita come &gt;=12 mesi di amenorrea spontanea nelle donne di età &gt;45 anni o &gt;=6 mesi di amenorrea spontanea con concentrazioni sieriche di FSH entro l’intervallo di riferimento per il post-menopausa come stabilito dal laboratorio); oppure • è stata sottoposta a ovariectomia bilaterale e/o isterectomia o a legatura bilaterale delle tube almeno 6 settimane prima dello screening; c. è una donna in età fertile e acconsente a: • praticare l’astinenza dall’attività eterosessuale (questa forma di contraccezione deve essere accettata dalle agenzie regolatorie e dai comitati di revisione locali come unico metodo di contraccezione); oppure • utilizzare (o far sì che il partner utilizzi) metodi anticoncezionali adeguati per la durata prevista della sperimentazione e per 21 giorni successivi all’ultima dose di farmaco in studio. I metodi anticoncezionali adeguati includono i seguenti: o uso di 2 metodi di barriera. I metodi di barriera accettabili sono: diaframma con spermicida, tappo cervicale, spugna contraccettiva, preservativo; o uso di un IUD e di uno dei metodi di barriera sopra elencati; o vasectomia del partner e uso di uno dei metodi di barriera sopra indicati. Nota: i soggetti di sesso femminile non devono interrompere l’uso dei contraccettivi ormonali, ma poiché non si è ancora concluso uno studio di interazione tra farmaci (DDI) per la valutazione degli effetti di MK-3102 sulla farmacocinetica di una combinazione di contraccettivi orali (estrogeno/progestina), non è noto se questi agenti da soli siano efficaci se assunti in concomitanza con MK-3102. Pertanto, se continua a usare un anticoncezionale ormonale, un soggetto di sesso femminile deve utilizzare un metodo di doppia barriera fino a quando non gli viene comunicato che tali studi sono stati completati e che si è esclusa una DDI. 4. Il soggetto comprende le procedure dello studio, i trattamenti alternativi disponibili, i rischi correlati allo studio e acconsente volontariamente a partecipare prestando il suo consenso informato scritto. Il soggetto può inoltre prestare il consenso alla Ricerca biomedica futura. Il rifiuto di prendere parte alla Ricerca biomedica futura non preclude la partecipazione del soggetto allo studio principale. 5. Il soggetto ha un’A1C ≥7,0% e ≤10,0% nelle 2 settimane precedenti la Visita 3/Settimana -2. Nota: se la A1C non rientra nell’intervallo previsto dal criterio di inclusione della Visita 3, la misurazione potrà essere ripetuta una volta a discrezione dello sperimentatore. Qualora la seconda misurazione soddisfi il criterio di inclusione della A1C alla Visita 3, il soggetto potrà continuare lo studio. 6. La compliance del soggetto al trattamento con il placebo corrispondente a MK-3102 [si veda il protocollo]
    E.4Principal exclusion criteria
    Subject 1. has a history of type 1 diabetes mellitus or a history of ketoacidosis or Subject is assessed by the investigator as possibly having type 1 diabetes confirmed with a C-peptide <0.7 ng/mL (0.23 nmol/L) 2. has been treated with: a. a thiazolidinedione (TZD) within 4 months of signing informed consent, or b. a GLP-1 receptor mimetic or agonist or DPP-4 inhibitors within 6 months of signing informed consent, or c. insulin within 12 weeks prior to signing informed consent 3. has a history of hypersensitivity to a DPP-4 inhibitor 4. is currently participating in/has participated in another trial with an investigational compound or device within the prior 12 weeks of signing the informed consent and does not agree to refrain from participating in any other trial 5. has a history of intolerance, hypersensitivity or any contraindication to metformin, glimepiride or other sulfonyurea based upon the label in the country of the investigational site. 6. is on a weight loss program and is not in the maintenance phase or has started a weight loss medication or has undergone bariatric surgery within 12 months prior to signing the informed consent 7. has undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the trial 8. Subject is on or likely to require treatment for ≥2 consecutive weeks or repeated courses of pharmacologic doses of corticosteroids 9. is currently being treated for hyperthyroidism or subject is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks 10. is currently on or likely to require treatment with a prohibited medication 11. is expecting to undergo hormonal therapy in preparation to donate eggs during the period of the trial, including 21 days following the last dose of trial medication. 12. has a medical history of active liver disease, including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease. 13. has HIV as assessed by medical history. 14. has had new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or has any of the following disorders within the past 3 months: a. Acute coronary syndrome b. Coronary artery intervention c. Stroke or transient ischemic neurological disorder 15. has poorly controlled hypertension defined as systolic blood pressure of ≥160 mm Hg or diastolic blood pressure of ≥90 mm Hg 16. has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer 17. has a clinically important hematological disorder 18. has exclusionary laboratory values (as per protocol) 19. has a positive urine pregnancy test 20. is pregnant or breast-feeding, or is expecting to conceive during the trial, including 21 days following the last dose of trial medication. 21. is a user of recreational or illicit drugs or has had a recent history of drug abuse 22. routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking. 23. has a history or current evidence of any condition that makes participation not in the subject's best interest 24. has donated blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent, or intends to donate blood products within the projected duration of the trial OR subject has received, or is anticipated to receive, blood products within 12 weeks of signing informed consent or within duration of the trial. 25. is unlikely to adhere to the trial procedures or is planning to relocate during the trial. 26. has symptomatic hyperglycemia that requires immediate initiation, adjustment, or addition of antihyperglycemic therapy or has a fasting plasma glucose consistently [please refer to the study protocol]
    1. Il soggetto ha una storia di diabete mellito di tipo 1 o di chetoacidosi. OPPURE Lo sperimentatore ritiene che il soggetto possa essere affetto da diabete di tipo 1 come confermato da un valore del peptide C &lt;0,7 ng/mL (0,23 nmol/L). 2. Trattamento con: a. un tiazolidinedione (TDZ) nei 4 mesi precedenti alla firma del consenso informato; oppure b. un mimetico o agonista del recettore del GLP-1 (come exenatide o liraglutide) o inibitori della DPP-4 nei 6 mesi precedenti la firma del consenso informato; oppure c. insulina nelle 12 settimane precedenti la firma del consenso informato. 3. Il soggetto ha una storia di ipersensibilità a un inibitore della DPP-4. 4. Il soggetto partecipa o ha partecipato a un altro studio su un composto o dispositivo sperimentale nelle 12 settimane precedenti la firma del consenso informato e non acconsente a non partecipare a eventuali altri studi durante la partecipazione a questo studio. 5. Storia di intolleranza, ipersensibilità o qualsiasi controindicazione nei confronti di metformina (nella Fase A) e glimepiride o altra sulfonilurea (nella Fase B) in base all’etichetta del farmaco nel Paese dove ha sede il centro di sperimentazione. 6. Il soggetto segue un programma dimagrante non in fase di mantenimento o ha iniziato ad assumere un farmaco dimagrante o ha subito un intervento di chirurgia bariatrica nei 12 mesi precedenti alla firma del consenso informato. 7. Il soggetto è stato sottoposto a una procedura chirurgica nelle 4 settimane precedenti la firma del consenso informato o deve sottoporsi a un intervento di chirurgia maggiore durante lo studio. 8. Il soggetto è in trattamento o necessita probabilmente di trattamento con corticosteroidi a dosi farmacologiche per &gt;=2 settimane consecutive o per cicli ripetuti. 9. Il soggetto è attualmente trattato per ipertiroidismo o è in terapia ormonale tiroidea a una dose non stabile da almeno 6 settimane. 10. Il soggetto è attualmente trattato o necessita potenzialmente di trattamento con un farmaco non consentito (vedere Sezione 3.2.1.2 per un elenco dei farmaci non consentiti). 11. Il soggetto è in attesa di sottoporsi a terapia ormonale in preparazione alla donazione di ovuli durante lo studio, inclusi i 21 giorni successivi all’ultima dose di farmaco in studio. 12. Il soggetto ha una storia clinica di epatopatia attiva (diversa dalla steatosi epatica non alcolica), inclusa epatite B o C cronica attiva (in base all’anamnesi), cirrosi biliare primaria o malattia della colecisti sintomatica. 13. Il soggetto è affetto da Infezione da virus dell’immunodeficienza umana (HIV) come confermato dall’anamnesi. 14. Negli ultimi 3 mesi il soggetto ha manifestato un peggioramento o la comparsa di nuovi segni e sintomi di coronaropatia o scompenso cardiaco congestizio, oppure uno dei disturbi seguenti: a. sindrome coronarica acuta (p. es. IM o angina instabile) b. intervento aorto-coronarico (p. es. CABG o PTCA) c. ictus o disturbo neurologico come attacco ischemico transitorio. 15. Il soggetto ha un’ipertensione scarsamente controllata, definita come pressione arteriosa sistolica &gt;=160 mmHg o pressione arteriosa diastolica &gt;=90 mmHg, e non si ritiene probabile che la pressione arteriosa scenda al di sotto di questi valori entro la Visita 3/Settimana -2 con un aggiustamento della terapia antipertensiva. 16. Il soggetto ha una storia di neoplasia maligna &lt;=5 anni prima della firma del consenso informato, fatta eccezione per il carcinoma cutaneo baso-cellulare o squamocellulare o il carcinoma in situ della cervice adeguatamente trattati. 17. Il soggetto ha un disturbo ematologico clinicamente importante (come anemia aplastica, sindromi mieloproliferative o mielodisplastiche, trombocitopenia). 18. I risultati degli esami di laboratorio che escludono il soggetto dalla partecipazione allo studio sono elencati nel protocollo. [si veda il protocollo]
    E.5 End points
    E.5.1Primary end point(s)
    A1C – Change from baseline at Week 24
    Variazione della A1C alla Settimana 24 rispetto al basale
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 settimane
    E.5.2Secondary end point(s)
    - 2 Hour Post-Meal Glucose – Change from baseline at Week 24 - Fasting Plasma Glucose – Change from baseline at Week 24
    - Variazione della glicemia postprandiale (PMG) a 2 ore alla Settimana 24 rispetto al basale - Variazione della glicemia a digiuno (FPG) alla Settimana 24 rispetto al basale
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 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 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 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) 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    India
    Korea, Republic of
    Philippines
    Taiwan
    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
    LVLS
    Ultima visita dell'ultimo paziente
    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 months31
    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 months31
    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: 380
    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 state96
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 171
    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)
    Subjects will return to their normal standard of care therapy
    I pazienti torneranno alla loro normale terapia standard
    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 Decision2013-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-19
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