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    Summary
    EudraCT Number:2011-004622-96
    Sponsor's Protocol Code Number:MK0431-260-00
    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:2011-12-16
    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 number2011-004622-96
    A.3Full title of the trial
    A Phase III, Multicenter, Randomized, Double-Blind, Placebo-
    Controlled Clinical Trial to Study the Safety and Insulin-Sparing
    Efficacy of the Addition of Sitagliptin in Patients With Type 2
    Diabetes Mellitus Who Have Inadequate Glycemic Control on
    Insulin Alone or in Combination With Metformin
    Studio clinico di fase III, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare la sicurezza e l'efficacia dell'aggiunta di Sitagliptin nella riduzione del dosaggio dell'insulina in pazienti affetti da Diabete Mellito di tipo II con inadeguato controllo glicemico in monoterapia con insulina o associata a Metformina.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III, Multicenter, Randomized, Double-Blind, Placebo-
    Controlled Clinical Trial to Study the Safety and Insulin-Sparing
    Efficacy of the Addition of Sitagliptin in Patients With Type 2
    Diabetes Mellitus Who Have Inadequate Glycemic Control on
    Insulin Alone or in Combination With Metformin
    Studio clinico di fase III, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare la sicurezza e l'efficacia dell'aggiunta di Sitagliptin nella riduzione del dosaggio dell'insulina in pazienti affetti da Diabete Mellito di tipo II con inadeguato controllo glicemico in monoterapia con insulina o associata a Metformina.
    A.3.2Name or abbreviated title of the trial where available
    MK0431-260-00
    MK0431-260-00
    A.4.1Sponsor's protocol code numberMK0431-260-00
    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.
    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.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Italia S.r.l.
    B.5.2Functional name of contact pointDivisione Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Fratelli Cervi, snc - Centro Direzionale Milano Due - Palazzo Borromini
    B.5.3.2Town/ citySegrate (MI)
    B.5.3.3Post code20090
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 21018402
    B.5.5Fax number+39 02 21018629
    B.5.6E-mailgcto.italy@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 Yes
    D.2.1.1.1Trade name JANUVIA*28CPR RIV 100MG
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP & DOHME 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 INNSITAGLIPTIN PHOSPHATE
    D.3.9.1CAS number 654671-78-0
    D.3.9.2Current sponsor codeMK-0431
    D.3.9.4EV Substance CodeSUB25200
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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
    D.8 Placebo: 1
    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
    Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Alone or in Combination With Metformin
    pazienti affetti da Diabete Mellito di tipo II con inadeguato controllo glicemico in monoterapia con insulina o associata a Metformina
    E.1.1.1Medical condition in easily understood language
    Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Alone or in Combination With Metformin
    pazienti affetti da Diabete Mellito di tipo II con inadeguato controllo glicemico in monoterapia con insulina o associata a Metformina
    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 LLT
    E.1.2Classification code 10049746
    E.1.2Term Insulin-requiring type II diabetes mellitus
    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
    After 24 weeks, to assess the effect of sitagliptin compared with placebo on the change in insulin dose in IU per day in patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on insulin with or without metformin, who titrate insulin glargine (Treat-to-Target). To assess the safety and tolerability of sitagliptin
    valutare l'efficacia di Sitagliptin 100 mg una volta al giorno rispetto al placebo sulla riduzione del dosaggio dell'insulina per un periodo di 24 settimane in pazienti con Diabete Mellito Tipo 2 (T2DM) che hanno un inadeguato controllo glicemico in monoterapia con insulina o associata alla Metformina
    E.2.2Secondary objectives of the trial
    In patients with T2DM with inadequate glycemic control on insulin with or without metformin, who titrate insulin glargine (Treat-to-Target): (1) After 24 weeks, to estimate the difference between sitagliptin and placebo on hemoglobin A1c . (2) After 24 weeks, to estimate the difference between sitagliptin and placebo on fasting plasma glucose. (3) After 24 weeks, to estimate the difference between sitagliptin and placebo on body weight. (4) After 24 weeks, to estimate the difference between sitagliptin and placebo in the proportion of patients who achieve the fasting glucose target of 72-100 mg/dL (4.0-5.6 mmol/L). (5) To estimate the difference between sitagliptin and placebo in the time to achieve the fasting glucose target of 72-100 mg/dL (4.0-5.6 mmol/L) for the first time.
    In pazienti con diabete mellito Tipo 2 con inadeguato controllo glicemico ed in trattamento con insulina con o senza metformina, che titolano l' insulina glargine (Treat to Target): (1) Obiettivo: Dopo 24 settimane valutare la differenza tra sitagliptin e placebo sul valore di A1C. (2) Obiettivo: Dopo 24 settimane valutare la differenza tra sitagliptin e placebo sul valore della glicemia plasmatica a digiuno (FPG). (3) Obiettivo: Dopo 24 settimane valutare la differenza tra sitagliptin e placebo sul peso corporeo. (4) Obiettivo: Dopo 24 settimane valutare la differenza tra stagliptin e placebo nella percentuale di pazienti che raggiungono il valore target della glicemia a digiuno di 72-100 mg/dL (4.0-5.6 mmol/L). (5) Obiettivo: Valutare la differenza tra sitagliptin e placebo nel tempo in cui si raggiunge il valore target della glicemia a digiuno di 72-100 mg/dL (4.0-5.6 mmol/L) per la
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Visit 1/Screening Visit: 1. Patient has type 2 diabetes mellitus (T2DM). 2. Patient meets one of the following criteria: A. Patient was diagnosed with diabetes after age 40 years and insulin therapy was initiated at least 3 years after the diagnosis of diabetes, OR - B.Patient does not meet the criteria in (A) above (i.e., diagnosis < age 40 years or insulin started earlier than 3 years after diagnosis), but has a fasting C-peptide of >0.7 ng/mL. Note: Only patients who do not meet the criteria in (A) should have a C-peptide level measured. 3. Patient must be ≥18 and ≤80 years of age on the day of signing informed consent. 4. Patient is on a stable insulin regimen for ≥10 weeks metformin (immediate-release or extended-release formulation) at ≥1500 mg/day for ≥10 weeks sulfonylurea for ≥10 weeks, with one of the following insulins (at a dose of at least 15 U/day and a maximum dose of 150 U/day) and has a Visit 1/Screening Visit A1C ≥7.5% and ≤11.0% (for patients not on sulfonylurea) or A1C ≥7.0% and ≤10.0% (for patients on sulfonylurea): • Pre-mixed insulin with at least 70% basal insulin (e.g., Novolog 70/30, Novolin 70/30, Humalog 75/25, or Humulin 70/30) once-daily or twice-daily. • Intermediate-acting insulin (e.g., NPH/Isophane) once-daily or twicedaily. • Long-acting insulin (e.g., Glargine [Lantus] and Detemir [Levemir]) once-daily or twice-daily. Note: A stable insulin regimen is defined as all daily doses within 10% (or within 2 units for patient taking ≤20U/day) of the usual administered dose (e.g., if usual insulin dose is 50 U/day, then doses of 45-55 U/day would be considered stable)
    1. Il paziente è affetto da diabete mellito Tipo 2 (T2DM). 2. Il paziente soddisfa uno dei seguenti criteri: A. Al paziente è stato diagnosticato il diabete dopo i 40 anni e la terapia insulinica è stata iniziata almeno 3 anni dopo la diagnosi di diabete OR B. Il paziente non soddisfa il criterio A) di cui sopra (ad es. la diagnosi è avvenuta prima dei 40 anni o la terapia con insulina è iniziata prima dei tre anni successivi alla diagnosi), ma ha il valore del C-peptide a digiuno &gt;0.7 ng/mL. 3. Il paziente deve avere un età compresa tra i ≥18 e ≤80 anni al momento della firma del consenso informato. 4. Il paziente è in trattamento stabile con insulina da almeno 10 settimane + metformina (formulazione a rilascio immediato o a rilascio prolungato) ad un dosaggio &gt; 1500 mg/die per almeno 10 settimane + sulfonilurea per almeno 10 settimane . 5. Il paziente comprende le procedure dello studio, i trattamenti alternativi disponibili e i rischi che lo studio comporta, e accetta volontariamente di partecipare dando il consenso informato scritto. Il paziente può anche fornire il consenso per Future Ricerche Biomediche. Tuttavia, il paziente può partecipare allo studio principale senza partecipare alle Future Ricerche Biomediche. 6. Il paziente è un uomo o una donna con una probabilità estremamente bassa di concepire. 7. Il paziente ha &gt; 85% di compliance (valutata con il numero delle compresse ) durante il trattamento con placebo nel periodo di run-in.
    E.4Principal exclusion criteria
    At Visit 1/Screening Visit: 1. Patient has been treated with a DPP-4 inhibitor, a thiazolidinedione (TZD), or a GLP-1 mimetic or analogue, within the prior 12 weeks. 2. Patient is currently on treatment with daily use (one or more injections per day) of a pre-prandial short-acting or rapid-acting insulin (e.g., aspart, glulisine, lispro, regular insulin) alone or as part of a basal/bolus insulin regimen. Note: Patients using a pre-mixed insulin containing a short-acting insulin may participate. 3. Patient has symptomatic hyperglycemia that, in the investigator’s opinion, requires immediate initiation, adjustment, or addition of antihyperglycemic therapy. 4. Patient has a history of 2 or more episodes of hypoglycemia resulting in seizure, coma, or loss of consciousness, - or - patient has had recurrent (≥3 times per week) episodes of hypoglycemia over the past 8 weeks. 5. Patient has a history of ketoacidosis. 6. Patient is, as assessed by the investigator, not appropriate for or does not agree to target a fasting glucose of 72-100 mg/dL [4.0-5.6 mmol/L]. 7. Patient has a history of intolerance or hypersensitivity to sitagliptin, insulin, or metformin (if patient on metformin at Visit 1) or any contraindication to sitagliptin, insulin, or metformin (if patient on metformin at Visit 1) based upon the label of the country of the investigational site. 8. Patient is pregnant or breast-feeding, or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study drug. 9. Patient has a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease. 10. Patient 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 (e.g., MI or unstable angina) b. Coronary artery intervention (e.g., CABG or PTCA) c. Stroke or transient ischemic neurological disorder At Visit 4/Randomization: 11. Patient has a site FFSG of <130 mg/dL (7.2 mmol/L) or >270 mg/dL (15.0 mmol/L). Note: If the patient meets this exclusion criterion AND the investigator believes that the value is not consistent with the patient’s current Self-Monitoring Blood Glucose (SMBG) values and Visit 3/Week -2 FPG value, the patient should not be excluded at this time. This visit should be changed to an Unscheduled Visit and the patient should be rescheduled for Visit 4/Day 1 within 7 days. Additional single-blind placebo run-in medication should be dispensed if needed. If the patient meets this FFSG exclusion criterion at the rescheduled Visit 4/Day1, the patient MUST be excluded
    1. Il paziente trattato con un inibitore del DPP-4 un tiazolinedione (TZD) o con un mimetico o analogo del GLP-1 entro le 12 settimane precedenti. 2. Il paziente attualmente in trattamento con l'uso quotidiano (uno o più iniezioni al giorno) di insulina pre-prandiale ad azione a breve durata o ad azione rapida (ad es. insulina aspartato, glulisina, lispro, regolare) da sola o come parte di un regime bolo/ basale di insulina. 3. Il paziente con una iperglicemia sintomatica che,a giudizio del ricercatore, richiede un immediato inizio, aggiustamento o aggiunta di una terapia anti iperglicemica. 4. Il paziente con una storia di 2 o più episodi di ipoglicemia con conseguente convulsione, coma o perdita di conoscenza, oppure, paziente che ha avuto ricorrenti (&gt; 3 volte alla settimana) episodi di ipoglicemia nelle ultime otto settimane. 5. Il paziente ha una storia di cheto acidosi. 6. Il paziente è, a giudizio del ricercatore, non adatto o non è d’accordo a ad avere come glicemia target a digiuno 72-100 mg/dL [4.0-5.6 mmol/L]. Per altri criteri si veda SINOSSI.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in daily insulin dose at Week 24.
    Variazione dal basale del dosaggio giornaliero di insulina alla Settimana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    24 settimane
    E.5.2Secondary end point(s)
    Efficacy Endpoints: laboratory assessment of: A1C, FPG, and lipid panel endpoints and time when a patient meets the fasting glucose target. Safety endpoints: adverse events, additional hypoglycemia endpoints, percentages of patients meeting predefined limits of change (PDLC) in laboratory parameters (including blood chemistry and hematology), and change (or percent change) from baseline at Week 24 in laboratory parameters, body weight and vital signs. Serious adverse events (SAEs) consistent with vascular events (cardiovascular, cerebrovascular, and peripheral vascular events) and heart failure events, revascularization procedures, and all deaths, regardless of cause, will be subject to adjudication by an expert committee external to the SPONSOR. When an eligible event is identified, the SPONSOR will request copies of additional source documentation related to the event (e.g., hospital records) from the investigator.
    Endpoint di efficacia: Analisi di laboratorio di: A1C, FPG ed gli endpoint del profilo lipidico ed il tempo in cui il paziente raggiunge il valore target della glicemia a digiuno. Endpoint di sicurezza: eventi avversi, gli endpoint di ipoglicemia aggiuntivi, la percentuale dei pazienti che raggiungono i predefiniti limiti di cambiamento (PDLC) nei parametri di laborastorio (che includono ematochimica ed ematologia), ed il cambiamento (o la percentuale del cambiamento) dal baseline fino a 24 settimane nei partametri di laboratorio, peso corporeo e segni vitali. Gli Eventi avversi seri (SAEs) definiti come eventi vascolari (eventi cardiovascolari, cerebrovascolari e vascolari periferici) ed eventi di insufficienza cardiaca, procedure di rivascolarizzazione, e tutte le morti, indipendentemente dalla causa saranno oggetto di un controllo da parte di un comitato di esperti indipendenti dallo SPONSOR. Se un evento eleggibile viene identificato, allo SPONSOR verranno richieste al ricercatore copie di ulteriore documentazione correlato all'evento (ad es. cartelle cliniche).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Australia
    Brazil
    Canada
    Guatemala
    India
    Israel
    Korea, Republic of
    Mexico
    New Zealand
    Peru
    Puerto Rico
    Russian Federation
    South Africa
    Turkey
    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
    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 months18
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    E.8.9.2In all countries concerned by the trial days20
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 288
    F.4.2.2In the whole clinical trial 600
    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.
    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 Decision2012-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-07
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