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    The EU Clinical Trials Register currently displays   37704   clinical trials with a EudraCT protocol, of which   6179   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-001758-17
    Sponsor's Protocol Code Number:LAST
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-001758-17
    A.3Full title of the trial
    Effect of Lixisenatide on arterial stiffness in patients with diabetic nephropathy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lixisenatide Arterial Stiffness Trial
    A.3.2Name or abbreviated title of the trial where available
    LAST
    A.4.1Sponsor's protocol code numberLAST
    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 SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    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 supportSanofi Aventis Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointJanaka Karalliedde
    B.5.3 Address:
    B.5.3.1Street Address3.33 FWB Waterloo Campus, Stamford Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 9NH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4402078484464
    B.5.5Fax number4402078484567
    B.5.6E-mailj.karalliedde@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorGuy's and St Thomas' NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportSanofi Aventis Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy's and St Thomas' NHS Foundation Trust
    B.5.2Functional name of contact pointJanaka Karalliedde
    B.5.3 Address:
    B.5.3.1Street Address3.33 FWB Waterloo Campus, Stamford Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 9NH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4402078484464
    B.5.5Fax number4402078484567
    B.5.6E-mailj.karalliedde@kcl.ac.uk
    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 Lyxumia
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Groupe
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameLixisenatide (Lyxumia)
    D.3.4Pharmaceutical form Suspension for injection in pre-filled pen
    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 INNLixisenatide
    D.3.9.1CAS number 320367-13-3
    D.3.9.3Other descriptive nameLIXISENATIDE
    D.3.9.4EV Substance CodeSUB32251
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 20
    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 placeboSolution for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous 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
    E.1.1.1Medical condition in easily understood language
    Diabetes
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 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
    To evaluate if treatment with Lixisenatide for 24 weeks reduces Ao-PWV in T2DM with DN.
    E.2.2Secondary objectives of the trial
    To evaluate if treatment with Lixisenatide reduces albumin excretion rate (AER), central aortic pressure, augmentation index, sodium balance, ANP, post prandial sodium, brachial artery pressure and other secondary exploratory objectives.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Written informed consent
     T2DM patients aged ≥40 years with DN defined as a history of an elevated AER [albumin:creatinine ratio (ACR) ≥2.5mg/mmol in men and ≥3mg/mmol in women or AER ≥20mcg/min] or positive urine dipstick result for proteinuria or urine protein creatinine ratios (PCR)>15 mg/mmol or clinical evidence of diabetic nephropathy] in the absence of other causes of renal damage or urinary tract infections,
     estimated glomerular filtration rate (eGFR)* ≥30 ml/min;
     On anti-hypertensive therapy with renin angiotensin system (RAS) inhibitor at a stable dose for at least 1 month prior to randomisation
     HbA1c ≥6.5% on anti-diabetic medications
     Body mass index ≥30 kg/m2 or ≥27 kg/m2 (people from black, Asian and other minority ethnic groups and for whom insulin therapy would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities)
    * by Modification of Diet in Renal Disease (MDRD) Study equation [186 x (Creat / 88.4)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if black) ]
    E.4Principal exclusion criteria
     Patients with eGFR<30 ml/min;
     Patients with recent (within 1 year) history of CVD event;
     Patients with uncontrolled hypertension defined as systolic BP and diastolic BP greater than 180 and 110mmHg respectively;
     Pregnancy or lactation;
     Females of child bearing potential or males able to father a child who do not agree to use suitable methods of contraception (as specified in section 4.7 of the Protocol)
     Patients with non diabetic renal disease;
     Patients expected to receive an increase in the dose of RAS inhibitors during the course of study;
     History of pancreatitis;
     Active gastrointestinal (GI) or biliary disease;
     Planned major GI surgery that can/could affect upper GI function;
     History or family history of thyroid cancer or multiple endocrine neoplasia 2;
     Known allergy/intolerance to GLP-1 receptor agonist treatment, metacresol or any of the IMP or placebo components.
     Subjects involved in current research or have recently (within 30 days) been involved in any research involving an IMP prior to recruitment.
     Subjects with insufficient understanding of the Trial or unable to comply with study requirements
     Subjects on basal insulin and a sulphonylurea at randomisation visit.
     Patients already on a GLP-1 receptor agonist therapy
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point will be change from baseline in Ao-PWV. The primary end point is change in Ao-PWV following 24 weeks with Lixisenatide as compared to 24 weeks of placebo treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    Exploratory secondary endpoints include changes in:
    - albumin excretion rate (AER),
    - central aortic pressure,
    - augmentation index,
    - sodium balance,
    - atrial natriuretic peptide (ANP),
    - post prandial sodium (at 2hrs and area under curve),
    - brachial artery pressure
    - panel of vascular and inflammatory markers [which will include VCAM-1, ICAM-1, MMP 2 and 9, serum elastase activity, high sensitive CRP]
    - AGE (known to be associated with arterial stiffness and albuminuria and potentially affected by GLP-1 agonists).
    - Samples will also be collected and for future analyses of cardio-renal and metabolic markers.

    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    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 No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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 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
    The trial will be closed when all participants have made their final visit, the data entered into the database and all queries resolved and the database locked.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    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.1.1.1In 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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state120
    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 study team will ensure that the subject continues with routine treatment for their type 2 diabetes and
    diabetic kidney disease. Lixisenatide/placebo will not be continued after the research has finished.
    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 Decision2016-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-14
    P. End of Trial
    P.End of Trial StatusOngoing
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