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    Summary
    EudraCT Number:2015-000825-35
    Sponsor's Protocol Code Number:U1111-1167-2731
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-06-08
    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 number2015-000825-35
    A.3Full title of the trial
    The effect of the glucagon-like peptide-1 analogue, liraglutide (Victoza®), on jejunostomy output and intestinal absorption in short bowel syndrome patients, a double-blind cross-over study
    Effekten af glucagon-like peptide-1 analogen, liraglutide (Victoza®), på jejunostomi output og tarmabsorption hos patienter med korttarmssyndrom, et dobbeltblindt overkrydsningsstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Liraglutide to Short Bowel Syndrome, a cross-over study
    Liraglutide til jejunostomipatienter, et overkrydsningsstudie
    A.3.2Name or abbreviated title of the trial where available
    Liraglutide (Victoza®) and Short Bowel Syndrome
    Liraglutide (Victoza®) til jejunostomipatienter
    A.4.1Sponsor's protocol code numberU1111-1167-2731
    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 SponsorRigshospitalet Blegdamsvej
    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 supportRigshospitalet Blegdamsvej
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet Blegdamsvej
    B.5.2Functional name of contact pointDepartment of Medical Gastroenterol
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4520481323
    B.5.6E-mailbekker@dadlnet.dk
    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.3.4Pharmaceutical form Solution 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 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/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 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
    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
    Short bowel syndrome (SBS) is a clinical situation with reduced absorptive mucosal surface due to extensive surgical resection. SBS leads to increased intestinal losses of fluids and electrolytes; restricted oral/enteral nutrition to reduce intestinal losses; disease-related hypophagia; lack of adaptive hyperphagia; accelerated gastrointestinal transit time
    E.1.1.1Medical condition in easily understood language
    Patients with a jejunostomy and a short bowel syndrome
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10049416
    E.1.2Term Short-bowel syndrome
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary aim of this project is to evaluate the effect of liraglutide treatment on several intestinal absorption factors in patients with a jejunostomy SBS. The primary endpoint is the quantity changes in the ostomy output after liraglutide treatment.
    E.2.2Secondary objectives of the trial
    - Intestinal absorption of wet weight, energy, macronutrients and electrolyte absorption
    - Urine production
    - Parenteral support volume
    - Body composition
    - Plasma-citrulline concentration
    - Postprandial concentration profile of: Liraglutide, glucagon-like peptide-1, glucagon-like peptide-2, peptide YY, glucose-dependent insulinotropic peptide, glucagon, cholecystokinin, gastrin, insulin, fibroblast growth factor 19, 7α-hydroxy-4-cholesten-3-one, triacylglycerol, free fatty acid, glucose and c-peptide
    - Gastrointestinal transit time by Scintigraphy, SmartPill and Paracetamol absorption test
    - Optional intestinal mucosa biopsy (length, width, height of villus)
    - Quality of Life
    - Gallbladder emptying rate
    - Bile acid concentration in ostomy output
    - Transient elastography of liver
    - Multi-omics analysis of urine, blood and ostomy output
    - Gut microbiome of ostomy output
    - Hepatic function by indocyanine green
    - Stoma nipple examination
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. must give written informed consent before participation;
    2. must be able to communicate with the investigator;
    3. patients with SBS-IF or intestinal insufficiency with end-jejunostomy;
    4. primary disease leading to SBS should be Mb. Crohn, volvulus, injury, mesenteric vascular disease or from benign origination;
    5. age groups 18-90 years;
    6. stable body weight (<5% weight deviance in past three month prior to screening);
    7. minimum 1 liter of parental support (fluid and/or nutrition) per week or an ostomy output exceeding 1500 gram/day;
    8. usual medicine must have been stable for at least four weeks and kept constant during whole study period;
    9. must have an eGFR (by the MDRD formula7) >30 mL/min/1.73 m2
    E.4Principal exclusion criteria
    1. females who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods*;
    2. systolic blood pressure > 180 mmHg;
    3. type-1 diabetes mellitus;
    4. chronic pancreatitis / previous acute pancreatitis;
    5. known or suspected hypersensitivity to trial product(s) or related product;
    6. treatment with oral glucocorticoids, calcineurin inhibitors, or DPP4 inhibitors which in the investigator’s opinion could interfere with glucose or lipid metabolism 90 days prior to screening;
    7. cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial;
    8. active inflammatory bowel disease or fistula;
    9. cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months;
    10. known with radiation enteritis or celiac disease; known or suspected abuse of alcohol or medicine;
    11. impaired liver function (transaminases > two times upper reference levels);
    12. clinically meaningful renal disease; subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2;
    13. the receipt of any investigational product 90 days prior to this trial;
    14. administration of glutamine or other growth factors for the past three months;
    15. upon Investigator’s judgment

    * Please view the Danish Health and Medicine Authority guideline on which type of contraception is considered safe in clinical trials on www.sundhedsstyrelsen.dk. Intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, injections with prolonged release and vaginal rings) are considered as adequate contraceptives. Sterilized or infertile subjects are exempt from the requirement to use contraception. In order to be considered sterilized or infertile, subjects must generally have undergone surgical sterilization (vasectomy/bilateral tubectomy, hysterectomy and bilateral ovariectomy) or be postmenopausal defined as 12 months or more with no menses prior to enrolment
    E.5 End points
    E.5.1Primary end point(s)
    Changes in ostomy wet weight output (g/d), before and after liraglutide/placebo treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluated by 72-hour metabolic balance study measured at:
    Before and after 8 weeks of liraglutide/placebo treatment
    E.5.2Secondary end point(s)
    - Intestinal absorption of wet weight, energy, macronutrients and electrolyte absorption
    - Urine production
    - Parenteral support volume
    - Body composition
    - Resting energy expenditure
    - Plasma-citrulline concentration
    - Size and color of stoma nipple
    - Postprandial concentration profile of: Liraglutide, glucagon-like peptide-1, glucagon-like peptide-2, peptide YY, glucose-dependent insulinotropic peptide, glucagon, cholecystokinin, gastrin, insulin, fibroblast growth factor 19, 7α-hydroxy-4-cholesten-3-one, triacylglycerol, free fatty acid, glucose and c-peptide
    - Gastric emptying rate (by scientigraphy)
    - Intestinal transit time (by scientigraphy)
    - Ostomy-i Alert
    - Quality of Life
    - Gallbladder emptying rate
    - Bile acid concentration in ostomy output
    - Transient elastography of liver
    - Multi-omics analysis of urine, blood and ostomy output
    - Gut microbiome of ostomy output
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluated before and after 8 weeks of liraglutide treatment, and before and after 8 weeks of placebo treatment
    Only Scientigraphic evaluation of gastric emptying rate and intestinal transit time will be evaluated on each treatment admission, and not be evaluated at baseline for any treatment period.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 trial16
    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 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
    30 days after LVLS. We will see the patients 30 days after last dosing to a safety check.
    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 months
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state16
    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)
    Safety control visit at 30 days after last injection of IMP.
    Adverse event tracking from last injection to safety control visit.
    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 Decision2015-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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