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    Summary
    EudraCT Number:2011-000753-24
    Sponsor's Protocol Code Number:DC2011LiBrain001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-07-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-000753-24
    A.3Full title of the trial
    Central effects of endogenous GLP-1 and the GLP-1 analog liraglutide on brain satiety and reward circuits and feeding behavior in diabetes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of the hormone GLP-1 in the brain regarding satiety and reward circuits and feeding behavior in diabetes.
    A.3.2Name or abbreviated title of the trial where available
    LIBRA
    A.4.1Sponsor's protocol code numberDC2011LiBrain001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01363609
    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 SponsorVU University Medical Center
    B.1.3.4CountryNetherlands
    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 supportVU University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Center
    B.5.2Functional name of contact pointJennifer ten Kulve
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31204442974
    B.5.5Fax number+31204440502
    B.5.6E-mailjs.tenkulve@vumc.nl
    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 holderNovoNordisk Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.2Product code liraglutide
    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 INNLIRAGLUTIDE
    D.3.9.1CAS number 204656-20-2
    D.3.9.3Other descriptive nameVictoza
    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 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.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 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 nameExendin 9-39
    D.3.2Product code U-1160
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameexendin 9-39
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/kg millimole(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.0006 to 0.012
    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.IMP: 3
    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 Lantus
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.3Other descriptive nameLantus
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number5
    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.IMP: 4
    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 Paracetamol Solution
    D.2.1.1.2Name of the Marketing Authorisation holderDaro
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameDaro paracetamol solution for children
    D.3.2Product code Daro paracetamol solution for children
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    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 INNPARACETAMOL
    D.3.9.1CAS number 103-90-2
    D.3.9.3Other descriptive nameDaro paracetamol solution
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    diabetes mellitus
    obesity
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Obesity
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10012594
    E.1.2Term Diabetes
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    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
    1) What the involvement of endogenous GLP-1 is in food-stimuli related CNS satiety and reward responses and the alterations in obese non-DM and T2DM
    2) How long term treatment with the GLP-1 analog liraglutide does affect food-stimuli related CNS satiety and reward responses in T2DM patients (before and after onset of clinically measurable body weight changes)?
    3) What are the effects of gastric bypass surgery on food-stimuli related CNS satiety and reward responses in obese individuals
    4) What is the involvement of the increased meal-related endogenous GLP-1 levels after gastric bypass surgery in food-stimuli related CNS satiety and reward responses and does pharmacological blocking of endogenous GLP-1 receptor activation, using a GLP-1 antagonist, differentially affects these responses before and after gastric bypass surgery in obese individuals?
    E.2.2Secondary objectives of the trial
    - Does treatment in obese T2DM individuals with pharmacological levels of GLP-1 analog changes the feeding behavior measured as quantitative (kg, kcal) and qualitative (nutrient composition;carbohydrates/fat/protein) and the choice in food?
    - Does treatment in obese T2DM individuals with pharmacological levels of GLP-1analog affect self-reported hunger and satiety, eating behavior and quality of life?
    - Does treatment in obese T2DM individuals with pharmacological levels of GLP-1 analog affect resting energy expenditure?
    - Does treatment in obese T2DM individuals with pharmacological levels of GLP-1 analog affect micravascular function?
    - Does gastric bypass surgery changes the feeding behavior and the choice in food? (similarly measured)
    - Does gastric bypass surgery affect self-reported hunger and satiety, eating behavior and quality of life?
    - Does gastric bypass surgery affect resting energy expenditure?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For the healthy, lean individuals:
    - Age 18–65 years
    - Women: post menopausal (excluding possible menstruation cycle effects)
    - Body-mass index (BMI) of <25 kg/m2,
    - Stable bodyweight (<5% reported change during the previous 3 months).
    - Normal fasting and 2h postload glucose as ascertained during a 75-g oral glucose tolerance test (OGTT)
    - Right handed

    For the obese individuals scheduled for gastric bypass surgery:
    - Age 18–65 years
    - Women: preferably post menopausal (excluding possible menstruation cycle effects)
    - Body-mass index (BMI) of >30 kg/m2,
    - Stable bodyweight (<5% reported change during the previous 1 months).
    - Normal or impaired fasting and 2h post load glucose as ascertained during a 75-g oral glucose tolerance test (OGTT) (defined normal; fasting < 5.6 mmol/l and after OGTT t=120min. < 7.8 mmol/l, impaired; fasting 5.7-7.1 mmol/l and after OGTT t=120min 7.9-11.0 mmol/l)
    - Right handed

    For the obese individuals with T2DM:
    - Age 18-65 years
    - Women: post menopausal (excluding possible menstruation cycle effects)
    - BMI 25–40 kg/m2
    - Stable bodyweight (<5% reported change during the previous 3 months).
    - Diagnosed with T2DM > 3 months prior to screening
    - HbA1C 6.5–8.5%
    - Treatment with metformin at a stable dose for at least 3 months.
    - Right handed
    E.4Principal exclusion criteria
    - GLP-1 based therapies, thiazolidinediones, sulphonylurea or insulin within 3 months before screening
    - Weight-lowering agents within 3 months before screening.
    - Congestive heart failure (NYHA II-IV)
    - Chronic renal failure (glomerular filtration rate < 60 mL/min/1.73m2 per Modification of Diet in Renal
    Disease (MDRD))
    - Liver disease
    - History of gastrointestinal disorders (including gastroparese, pancreatitis and cholelithiasis)
    - Neurological illness
    - Malignancy
    - History of major heart disease
    - History of major renal disease
    - Pregnancy or breast feeding
    - Implantable devices
    - Substance abuse
    - Addiction
    - Contra-indication for MRI, such as claustrophobia or pacemaker
    - Any psychiatric illness; including eating disorders and depression
    - Chronic use of centrally acting agents or glucocorticoids within 2 weeks immediately prior to screening.
    - Use of cytostatic or immune modulatory agents
    - History of allergy for acetaminophen.
    - History of allergy for insulin analog
    - History of allergy for liraglutide or other GLP-1 RA/analog
    - Participation in other studies
    - Individuals who have received treatment within the last 30 days with a drug that has not received
    regulatory approval for any indication at the time of study entry
    - Individuals who are investigator site personnel, directly affiliated with the study, or are immediate family
    of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse,
    parent, child, or sibling, whether biological or legally adopted.
    - Individuals who have previously completed or withdrawn from this study or any other study investigating
    GLP-1 receptor agonist or dipeptidyl peptidase (DPP)-4 within 6 months
    - Left handed.
    - Individuals who, in the opinion of the investigator, are unsuitable in any other way to participate in this
    study.
    - Individuals who are employed by NovoNordisk & comp. (that is, employees, temporary contract workers,
    or designees responsible for conducting the study).
    - Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding
    the purpose, instruction and hence participation in the study.
    - Further exclusion criteria will be in compliance with the EMeA SPC of liraglutide.
    E.5 End points
    E.5.1Primary end point(s)
    - Increase of understanding of the mechanism underlying the central effects of endogenous GLP-1 in the regulation of feeding behavior and appetite control.
    - Determine alterations in this regulation that may occur in obese and T2DM individuals. Gain insight into the CNS mechanisms underlying the development of obesity, the difficulties of losing weight in these individuals and the additional impact of T2DM on these CNS mechanisms.
    - Determine the effects of treatment in obese T2DM individuals with pharmacological levels of GLP-1 on the central regulation centers of feeding behavior and appetite control and meal-related activity in CNS.
    - increase our understanding in the mechanism underlying the effects of gastric bypass surgery on body weight and feeding behaviour and and the role of increased GLP-1 levels after this surgery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    during and/or after participant enrollment
    E.5.2Secondary end point(s)
    Effects of gastric bypass surgery in obese (normo-glycaemic) individuals and of the GLP-1 analog treatment in obese patients with type 2 diabetes in:
    - self-reported hunger, satiety, fullness
    - basal metabolic rate and post-prandial energy expenditure
    - microvascular function and vasomotion
    - cardiovascular autonomic nervous balance
    - concomitant changes in metabolic and humoral markers
    E.5.2.1Timepoint(s) of evaluation of this end point
    during and/or after participant enrollment
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    mechanistic, adressing contribuition of action of GLP-1 receptor agonist in brain circuits
    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 Yes
    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 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
    last visit of the last subject
    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
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1.1Number 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: 50
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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.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)
    not expected. Patiënt will continue control by own physician.
    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 Decision2011-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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