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    Summary
    EudraCT Number:2011-001254-29
    Sponsor's Protocol Code Number:I2R-MC-BIAM
    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:2011-12-28
    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 number2011-001254-29
    A.3Full title of the trial
    The Impact of LY2605541 versus Insulin Glargine for
    Patients with Type 2 Diabetes Mellitus Advanced to
    Multiple Injection Bolus Insulin with Insulin Lispro: a
    Double-Blind, Randomized, 26-Week Study
    The IMAGINE 4 Study
    Effetti di LY2605541 e insulina Lispro rispetto a insulina glargine e insulina Lispro in pazienti con diabete mellito di tipo 2 in terapia insulinica multi-iniettiva: Studio in doppio cieco, randomizzato, di 26 settimane
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study in Type 2 Diabetes
    Studio su pazienti diabetici di tipo 2
    A.3.2Name or abbreviated title of the trial where available
    IMAGINE 4
    IMAGINE 4
    A.4.1Sponsor's protocol code numberI2R-MC-BIAM
    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 SponsorELI LILLY
    B.1.3.4CountryItaly
    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 supportBoehringer Ingelheim International GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressErl Wood Manor, Sunninghill Road
    B.5.3.2Town/ cityWindlesham
    B.5.3.3Post codeGU20 6PH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441276483369
    B.5.5Fax number+441276483378
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameLY2605541
    D.3.2Product code LY2605541
    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.3.9.2Current sponsor codeLY2605541
    D.3.9.3Other descriptive nameBasal Insulin Lispro
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    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 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 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 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 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 nameInsulin Glargin
    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 GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    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 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 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 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: 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 HUMALOG PEN*5PENNE 100U/ML 3ML
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY ITALIA 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 LISPRO
    D.3.9.1CAS number 133107-64-9
    D.3.9.4EV Substance CodeSUB08198MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    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 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.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
    Pazienti diabetici di Tipo 2
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Diabete
    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 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
    The primary objective is to demonstrate that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to 26 weeks, for LY2605541 is non-inferior compared with insulin glargine when each is combined with preprandial insulin lispro with or without metformin in patients with T2DM who have not achieved adequate glycemic control with at least 1 injection of insulin daily with or without OAMs. The non-inferiority margin is 0.4%.
    L'obiettivo primario è quello di dimostrare che il controllo glicemico, come misurato dal cambiamento dell'emoglobina A1c (HbA1c) dal basale a 26 settimane, per LY2605541 non è inferiore rispetto all'insulina glargine, quando combinate con insulina lispro preprandiale con o senza metformina in pazienti con diabete mellito di tipo 2 che non hanno raggiunto un adeguato controllo glicemico con almeno 1 iniezione di insulina al giorno, con o senza OAM. Il margine di non inferiorità è di 0,4%.
    E.2.2Secondary objectives of the trial
    The gated secondary objectives are to demonstrate that LY2605541 is superior to insulin glargine (each in combination with preprandial insulin lispro) for: 1. Nocturnal hypoglycemia rate during 26 weeks of treatment 2. Proportion of patients with HbA1c <7.0% at 26 weeks using last observation carried forward (LOCF) and no nocturnal hypoglycemia during the 26 weeks 3. HbA1c change from baseline after 26 weeks of treatment 4. Proportion of patients with HbA1c <7.0% after 26 weeks of treatment (LOCF) 5. Fasting serum glucose (FSG) by laboratory measurement after 26 weeks of treatment 6. Total hypoglycemia rate during the 26 weeks of treatment.
    Gli obiettivi secondari gated servono a dimostrare che LY2605541 è superiore all’insulina glargine (entrambe in combinazione con insulina lispro preprandiale) per: 1. Percentuale di ipoglicemia notturna durante le 26 settimane di trattamento 2. Proporzione di pazienti con HbA1c &lt;7,0% a 26 settimane con ultima osservazione portata a termine (LOCF) e nessuna ipoglicemia notturna durante le 26 settimane 3. Variazione HbA1c dal basale dopo 26 settimane di trattamento 4. Proporzione di pazienti con HbA1c &lt;7,0% dopo 26 settimane di trattamento (LOCF) 5. Glicemia a digiuno (FSG) mediante misurazione di laboratorio dopo 26 settimane di trattamento 6. Percentuale totale di ipoglicemia durante le 26 settimane di trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female patients diagnosed with T2DM (for at least 1 year), aged ≥18 years, with a body mass index ≤45.0 kg/m2. Patients should have HbA1c value ≥7.0% to <12.0% at screening; and be taking at least 1 injection of insulin per day with or without OAMs
    Pazienti di sesso maschile o femminile con diagnosi di diabete mellito di tipo 2 (per almeno 1 anno), di età ≥ 18 anni, con un indice di massa corporea ≤ 45,0 kg / m 2. I pazienti devono avere un valore di HbA1c compreso tra ≥ 7,0% e &lt; 12,0% allo screening e ricevere almeno 1 iniezione di insulina al giorno, con o senza OAM.
    E.4Principal exclusion criteria
    . Patients should not have had any episode of severe hypoglycemia or have had 2 or more emergency room visits/ hospitalizations due to poor glucose control or 1 or more hospitalizations for episodes of ketoacidosis or hyperosmolar state/coma within 6 months prior to Visit 1.
    . I pazienti non devono aver avuto alcun episodio di ipoglicemia grave o non essersi sottoposti a 2 o più visite al pronto soccorso/ricoveri a causa di scarso controllo glicemico o 1 o più ricoveri per episodi di chetoacidosi o stato iperosmolare/coma entro 6 mesi prima della Visita 1.
    E.5 End points
    E.5.1Primary end point(s)
    HbA1c change from baseline, HbA1c, nocturnal and overall hypoglycemia, FSG from central laboratory, FBG from SMBG, FBG intra-patient variability (SMBG) as measured by standard deviation, proportion of patients with HbA1c < 7.0% without nocturnal hypoglycemia, proportion of patients with HbA1c <7.0% and ≤6.5%, SMBG 9-point profiles, body weight change, and basal and bolus insulin dose.
    Modifica dell'HbA1c rispetto al basale, ipoglicemia HbA1c notturna e generale, FSG dal laboratorio centrale, FBG da SMBG, variabilità intra-paziente FBG (SMBG) come misurato dalla deviazione standard, proporzione di pazienti con HbA1c < 7,0% senza ipoglicemia notturna, proporzione di pazienti con HbA1c < 7,0% e profili a 9 punti SMBG ≤ 6,5%, variazione del peso corporeo e dose di insulina al basale e bolo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    26 weeks
    26 settimane
    E.5.2Secondary end point(s)
    TEAEs, SAEs, selected adjudicated cardiovascular events, AEs of special interest, antibodies to LY2605541, treatment exposure, chemistry panel measures, lipid panel measures, hematology panel measures, urinalysis measures, and vital signs.
    TEAE, eventi avversi gravi, eventi cardiovascolari aggiudicati selezionati, eventi avversi di particolare interesse, anticorpi anti LY2605541, esposizione al trattamento, misure del pannello chimico, misure del pannello lipidico, misure del pannello ematologico, valori delle analisi delle urine e segni vitali.
    E.5.2.1Timepoint(s) of evaluation of this end point
    26 weeks
    26 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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Croatia
    Israel
    Japan
    Mexico
    Russian Federation
    Taiwan
    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 months19
    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 months19
    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: 994
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 331
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 575
    F.4.2.2In the whole clinical trial 1325
    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)
    The Sponsor will not provide patients with ongoing supplies of study
    medication after they have completed the study treatment period
    because LY2605541 is experimental, while insulin glargine is readily
    available.
    Lo Sponsor non fornisce il farmaco alla fine dello studio in quanto Glargine è già sul mercato e LY non lo sarà alla fine dello studio.
    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 Decision2012-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
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