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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-002422-78
    Sponsor's Protocol Code Number:1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-002422-78
    A.3Full title of the trial
    Impact of liraglutide on cardiac function and structure in young adults with type 2 diabetes: an open lable, randomised active-comparator trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparing the effects of two new therapies for diabetes on the heart, measures of fat and diabetes in young people with type 2 diabetes
    A.3.2Name or abbreviated title of the trial where available
    Effects of Liraglutide in Young adults with Type 2 DIAbetes (LYDIA)
    A.4.1Sponsor's protocol code number1
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1131-8802
    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 SponsorUniversity of Leicester
    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 supportNovoNordisk
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportNIHR investigator funding
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Leicester
    B.5.2Functional name of contact pointMelanie Davies
    B.5.3 Address:
    B.5.3.1Street AddressLeicester Diabetes Centre
    B.5.3.2Town/ cityLeicester General Hospital, Leicester
    B.5.3.3Post codeLE54PW
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01162586481
    B.5.6E-mailmelanie.davies@uhl-tr.nhs.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 Victoza
    D.2.1.1.2Name of the Marketing Authorisation holderNovo NOrdisk
    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 nameVictoza (9660) 6mg/ml solution for injeciton in pre-filled pen
    D.3.2Product code EMEA/H/C/001026
    D.3.4Pharmaceutical form 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 CodeAS1
    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 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 Januvia
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme, MSD
    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 nameJanuvia (sitagliptin) 100mg film-coated tablets
    D.3.2Product code EMEA/H/C/000722
    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
    D.3.9.1CAS number 486460-32-6
    D.3.9.4EV Substance CodeAS2
    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 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 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
    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
    E.1.1.1Medical condition in easily understood language
    Diabetes
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    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
    The principal question is whether Lirgalutide improves cardiac function (as measured by left-ventricular function) to a greater extent than Sitagliptin in younger adults with type 2 diabetes who are likely to present with abnormalities.
    E.2.2Secondary objectives of the trial
    Secondary research ojecticves include: 1) Liraglutide therapy leads to greater improvements in the composite outcome of HbA1c <7.0%, no weight gain and no major or minor hypoglycaemiac compared to Sitagliptin 2)Liraglutide therapy leads to greater reductions in HbA1c compared to Sitagliptin 3)Liraglutide therapy leads to greater weight loss compared to Sitagliptin 4)Liraglutide therapy leads to improved endothelial function compared to Sitagliptin 5)Liraglutide therapy leads to greater renal sodium excretion compared to Sitagliptin 6)Liraglutide therapy does not increase baroreflex sensitivity and heart rate variability compared with Sitagliptin 7)Liragludite therapy leads to improved cardiorespiratory fitness ccompared to Sitagliptin 8)Liraglutide therapy is associated with improved quality of lifestyle and treatment satisfaction compared to Sitagliptin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Capacity to provide informed consent before any trial-related activities •Aged 18 – 50 years inclusive •Established T2DM (>12 months) •BMI ≥ 30 kg/m2 (≥27 kg/m2 for South Asians or other BME populations) •On mono or combination oral OAD therapy (sulphonylurea and/or metformin) for ≥ 3 months •No prescribed thiazolidinediones within the last 3 months •An HbA1c value of >= 6.5% and <= 10%
    E.4Principal exclusion criteria
    •Absolute contraindications to MRI •Type 1 diabetes (identified through C-peptide analysis) •Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods •Suffer from terminal illness •Have impaired renal function (eGFR < 30 ml/min/1.73m2) ) •Impaired liver function (ALAT≥2.5 times upper limit of normal) •Known to be Hepatitis B antigen or Hepatitis C antibody positive •Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III and IV) at the discretion of the investigator •Recurrent major hypoglycaemia as judged by the investigator •Known or suspected allergy to the trial products •Receipt of any investigational drug within four weeks prior to this trial •Have severe and enduring mental health problems •Are not primarily responsible for their own care •Are receiving insulin therapy •Have taken a thiazolidinedione within the last 3 months •Any contraindication to Sitagliptin or Liraglutide •Have severe irritable bowel disorder •Have pancreatitis or a previous history of pancreatitis
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for this study is change in left ventricular diastolic dysfunction at 26 weeks (6 months)post intervention. This will be determined by peak end diastolic strain rate measured via tagged cardiac MRI - the gold standrad technique.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cardiac MRI will be preformed at baseline (time-point -2 weeks) and at 26 weeks (6 months) follow-up
    E.5.2Secondary end point(s)
    There are a host of secondary outcomes which are listed below 1) Other measures of cardiac function: • Peak Systolic Strain • Left Ventricular Ejection Fraction • stroke volume • LV end-diastolic volume • LV end-systolic volume • LV end-diastolic mass • Left Ventricular End Diastolic Mass/volume ratio • Pre-and post contrast T1 mapping to calculate volume of distribution, a marker of diffuse cardiac fibrosis • Myocardial Perfusion Reserve ( a measure of microvascular function) Biochemical variables • HbA1c, • Liver Function Tests • plasma vitamin D • Lipid profile including total-, LDL- and HDL-cholesterol and triglycerides • Thyroid function tests Albuminuria and microalbuminuria • Urine Sodium and biocarbonate excretion Inflammatory variables • Interleukin-6 • C-reactive protein • Leptin • Adiponectin Anthropometric variables • BMI • Weight • Percentage body fat • Waist Circumference • Systolic and Diastolic Blood pressure • Heart rate (after resting seated for • at least 5 minutes) • Heart Rate Variability (HRV) via spectral analysis Endothlial function • Serum ICAM-1 measurement MRI defined adiposity • Subcutaneous, visceral and hepatic adiposity volumes (measured through semi-automated analysis) Quality of life and depression • EQ5D • Hospital anxiety and depression score (HADS) Treatment satisfaction • DTSQ Medication usage Hypoglycemia - self-reported in a standardized hypoglycemia diary. Participants will be enabled to self-monitor their glucose levels throughout the course of the trial And other adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data collection takes place at the following time-points -2,2,4,6,9,12,17,21 and 26 weeks. However not all data collected at baseline (-2 weeks)is repeated at these follow-up seesions as detailed below; Standard biochemical variables at time point -2,9,12,17,21 and 26 weeks Inflammation at time points -2,12 and 26 weeks Anthropometric at time points -2,2,4,6,9,12,17,21 and 26 weeks Emdothelial function at time points -2 and 26 weeks Lifestyle variables at time points -2,12 and 26 weeks QoL and depression at time points -2,12 and 26 weeks Treatment satisfaction at timepoints -2,12 and 26 weeks Cardiac function at timepoints -2,12 and 26 weeks Adverse events 0-2,2,4,6,9,12,17,21 and 26 weeks Medication use -2,2,4,6,9,12,17,21 and 26 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    The end of the trial is defined as the last recruited participant's final visit. We will however write to each participant at sometime in the future to provide them with a summary of the main findings of this trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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)
    Continuation of the medication received during the study will be discussed on a one-to-one basis with the study clinician at the end of the trial. The alterations made to the participant's baseline medication regime will be discussed inline with NICE guidance, local guide…..
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-29
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