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    The EU Clinical Trials Register currently displays   43440   clinical trials with a EudraCT protocol, of which   7185   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:2011-005405-78
    Sponsor's Protocol Code Number:2011430
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-04
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2011-005405-78
    A.3Full title of the trial
    Adding liraglutide to the backbone therapy of biguanide in patients with coronary artery disease and newly diagnosed type-2 diabetes
    Effekt af liraglutid og metformin på betacellen og hjertet hos koronar syge patienter med nyligt diagnosticeret type 2 diabetes

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of liraglutide on the treatment of coronary artery disease and type 2 diabetes
    Betydning af liraglutid på behandling af kranspulsåre hjertesygdom og type 2 diabtes
    A.3.2Name or abbreviated title of the trial where available
    AddHope2
    AddHope2
    A.4.1Sponsor's protocol code number2011430
    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 SponsorSteen Bendix Haugaard
    B.1.3.4CountryDenmark
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportFonden til Videnskabens Fremme
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDept of Cardiology, University Hospital of Copenhagen, Bispebjerg
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDept of Internal Medicine, University Hospital of Copenhagen, Amager
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept Cardiology, Copenhagen University Hospital, Bispebjerg, Denmark
    B.5.2Functional name of contact pointAhmad Sajadieh, MD, DMSc
    B.5.3 Address:
    B.5.3.1Street AddressBispebjerg Bakke
    B.5.3.2Town/ cityCopenhagen NW
    B.5.3.3Post codeDK-2400
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4525330519
    B.5.6E-mailasajadieh@yahoo.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 Victoza
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameLiraglutide
    D.3.4Pharmaceutical form Concentrate for 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 INNLIRAGLUTIDE
    D.3.9.1CAS number 204656-20-2
    D.3.9.4EV Substance CodeSUB25238
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.6 to 1.8
    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 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 Metformin
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf.
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 g gram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number.5 to 2
    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 placeboInjection
    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
    Patients suffering of both Type 2 diabetes mellitus and coronary artery disease
    E.1.1.1Medical condition in easily understood language
    Patients with both coronary heart disease and 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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10011079
    E.1.2Term Coronary artery disease NOS
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    Main Objective of the Trial
    To investigate whether glucagon-like peptide-1 (GLP-1) analogue combined with metformin therapy compared to metformin monotherapy
    a) improves betacell function
    b) improves left ventricular ejection fraction (LVEF) during stress test
    in newly diagnosed type-2 diabetes mellitus (T2D) patients, who exhibit stable coronary artery disease (CAD)
    E.2.2Secondary objectives of the trial
    Secondary Objective of the Trial
    To investigate whether glucagon-like peptide-1 (GLP-1) analogue combined with metformin therapy compared to metformin monotherapy
    a) improves insulin sensitivity and food induced glucagon response
    b) improves prognostic markers of cardiovascular disease,including 24 h heart rate variability (HRV) and diurnal blood pressure
    in newly diagnosed type-2 diabetes mellitus (T2D) patients, who exhibit stable coronary artery disease (CAD)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Stable CAD documented by either;
    a) previous MI (a minimum of 6 weeks after acute MI)
    b) previous coronary revascularization
    c) CAD confirmed by an abnormal coronary arteriograph (CAG) or CT-angiography showing stenosis > 50% of any major coronary arteries.
    Body mass index (BMI) >/= 25,0 kg/m2
    Age from 18 to 85 years of age
    Type 2 diabetes diagnosed either as:
    a) HbA1c >/= 6.5% but </= 8.5%
    b) HbA1c <6.5 % and fasting plasma glucose >/= 7.0 mmol/l (confirmed)
    c) HbA1c <6.5 % and a 2 h plasma glucose value during OGTT >/= 11.1 mmol/l
    The data for glucose metabolism are accepted provided that they have been obtained within 20 weeks before screening of the patient. The glucose metabolic categories are defined by ADA and WHO criteria
    E.4Principal exclusion criteria
    Type 1 diabetes mellitus defined as C-peptide < 450 pM
    Previously diagnosed diabetes mellitus before screening by OGTT except from previous gestational diabetes
    Previous use of antidiabetic medication except from use during previous gestational diabetes. It is accepted that the patient has been treated with oral anti diabetic drugs (OAD) after diagnosis of T2D as long as the patient pause OAD at least 4 weeks before baseline measurements in this trial
    Significant heart disease (NYHA > 2; Ejection Fraction < 40%, unstable angina pectoris, atrial fibrillation)
    Liver disease (transaminases > x2 greater than upper normal level)
    Renal diseases (eGFR < 50)
    Any chronic medical condition to unduly increase risk for the potential enrollee as judge by study investigators
    Anemia (<85% of lower normal limit), leucopenia (<85% of lower normal limit), or thrombocytopenia (< 85% of lower normal limit)
    Pregnancy or failure to comply with contraceptional planning within two years, or breastfeeding
    Abuse of alcohol or drugs, or any other co-existing condition that would make patients unsuitable to participate in the study, as deemed by the investigators
    Use of immunosuppressive therapy in the preceding 12 months
    Chronic pancreatitis / previous acute pancreatitis
    Known or suspected hypersensitivity to trial product(s) or related products
    Treatment with oral glucocorticoids, calcineurin inhibitors, or dipeptidyl peptidase 4 (DPP4) inhibitors, or other GLP-1 mimetics (Exenatide), which in the Investigator’s opinion could interfere with glucose metabolism
    Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, which in the Investigator’s opinion could interfere with the results of the trail
    Inflammatory bowel disease
    Previous bowel resection
    Clinical signs of diabetic gastroparesis
    The receipt of any investigational product 90 days prior to this trial
    Screening calcitonin ≥ 50 ng/l
    Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2
    Refusal to sign informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    Endocrine:
    1) Beta-cell function (disposition index) as measures during an intravenous glucose tolerance test (By Bergman Minimal Model)
    Cardiovascular:
    1) Dobutamine (stress) induced changes in Left ventricular ejection fraction (LVEF)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpoints will be evaluated at baseline (week 0), after week 12, after week 14 (following 2 weeks of wash-out) and finallty after week 26
    E.5.2Secondary end point(s)
    Endocrine/metabolic:
    a) Glucagon, incretin, glucose, NEFA, insulin and C-peptide response during meal test
    b) Insulin sensitivity (Si), acute insulin and C-peptide response to intravenous glucose (AIRg, ACRg), glucose clearance (Kg), glucose effectiveness (Sg) and hepatic extraction of insulin (HEXi) derived from a standard frequent sampling intravenous glucose tolerance test (FSIGT, Minimal model)
    c) CRP, TNF╬▒ and IL-6 in plasma and gene expression of IL6 and TNFa in sc. fat
    d) NEFA during FSIGT by use of NEFA minimal model

    Cardiovascular:
    a) Heart rate variability in particular SDNN, i.e. the standard deviation of all normal RR interval assessed during HOLTER monitoring)
    b) Maximal velocity of the myocardium in systole (s´) and in diastole (e´) during the dobutamine stress test
    c) Changes in exercise tolerance test variables: Total exercise duration (sec), time to limiting angina (sec) and time to 1 mm ST-segment depression (sec)
    d) ST-depression and ectopic activity assessed during 24h HOLTER monitoring
    e) Diurnal blood pressure
    f) Diastolic heart function (E/E*) in rest and during stress
    g) The liraglutide effect on LVEF during the dobutamine stress test is supposed to be most prominent in those patients with remaining ischemic components of the heart, i.e. those with significant stenosis where fully revascularization has not been obtained.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The endpoints will be evaluated at baseline (week 0), after week 12, after week 14 (following 2 weeks of wash-out) and finallty after week 26
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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.8.5.1Number of sites anticipated in the EEA1
    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
    Anticipated to be November 2013 but will be possible to extend this date another 6 months
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    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: 20
    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 No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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 patients are in general referred to their usual ambulant care units after having completed the trial. Should there be any adverse event or adverse reaction that would require special care, this will be provided free of charge to the specific patients from the investigator and sponsor of this trial.
    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 Decision2012-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-07
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