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    Summary
    EudraCT Number:2014-000397-19
    Sponsor's Protocol Code Number:Ctrl-DM2
    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:2014-09-08
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-000397-19
    A.3Full title of the trial
    Effects of Combined Treatment of Surgery and Liraglutide on Glycemic Variability and Control in type 2 Diabetes Mellitus:
    The Ctrl-DM2 Study
    Effecten van gecombineerde behandeling van chirurgie en liraglutide op glycemische variabiliteit en controle bij type 2 diabetes mellitus.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of weight reducing surgery and liraglutide on blood glucose in diabetes.
    Effecten van gewichtsverminderende chirurgie en liraglutide op bloedsuikerwaarden bij diabetes
    A.3.2Name or abbreviated title of the trial where available
    Ctrl-DM2 study
    Ctrl-DM2 studie
    A.4.1Sponsor's protocol code numberCtrl-DM2
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1128-2063
    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 Medical Center Groningen
    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 supportNovo Nordisk
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointa.p.van.beek@umcg.nl
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 30001
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700 RB
    B.5.3.4CountryNetherlands
    B.5.6E-maila.p.van.beek@umcg.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 liraglutide
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk
    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.3.4Pharmaceutical 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.3.11 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
    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 with morbid obesity
    type 2 diabetes met morbide obesitas
    E.1.1.1Medical condition in easily understood language
    diabetes and obesity
    diabetes and obesitas
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish the efficacy of 1.8 mg liraglutide compared to liraglutide-placebo in reducing glycemic variability and achieving glycemic control during 16 weeks treatment before surgery and 48 weeks (week 4 to 52) treatment after gastric bypass surgery for morbid obesity complicated by DM2.
    De effectiviteit van 1.8 mg liraglutide te vergelijken met placebo in het verminderen van glycemische variabiliteit en controle gedurende 16 weken behandeling voor bariatrische chirurgie en 48 weken (week 4 tot 52) na behandeling middels een gastric bypass voor morbide obesitas gecompliceerd door type 2 diabetes.
    E.2.2Secondary objectives of the trial
    To establish the efficacy of 1.8 mg liraglutide compared to liraglutide-placebo in inducing a change in body weight, cardiovascular risk profile and patient reported outcomes (quality of life, eating behaviour and dumping syndrome score).

    To establish a biobank containing blood (plasma), DNA, subcutaneous and visceral fat, as well as gastro-intestinal tissues with the intention to future research on the effects of liraglutide on adipose tissue and gastro-intestinal endocrine cells.
    De effectiviteit van 1.8 mg liraglutide te vergelijken met placebo in het induceren van een verandering in lichaamsgewicht, cardiovasculair risicoprofiel en door de patient zelf gerapporteerde uitkomstmaten zoals kwaliteit van leven, dumpingklachten en eetgedrag.

    Een biobank te maken met bloed (plasma) monsters, DNA, subcutaan en visceraal vet en gastrointestinaal weefsel met de bedoeling daarmee toekomstig onderzoek te kunnen doen naar de effecten van liraglutide op vetweefsel en entero-endocriene cellen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - give written informed consent,
    - age ≥ 18 and ≤65 years,
    - type 2 diabetes mellitus on diet/lifestyle intervention with or without metformin,
    - a body mass index ≥ 35 kg/m2 (1991 NIH Guidelines for Bariatric Surgery),
    - for women of childbearing age, must have a negative pregnancy test at screening, and agree to use contraceptives for the duration of the study,
    - are able to understand and comply with the study process.
    E.4Principal exclusion criteria
    - a diagnosis of type 1 diabetes mellitus, LADA or MODY,
    - patients with severe gastrointestinal disease, including gastroparesis,
    - have a contraindication for bariatric surgery,
    - an endocrine form of obesity (e.g. Cushing syndrome),
    - breastfeeding
    - currently using or have used within three months before this trial: any drug for the treatment of obesity (patients must also agree to not use these medications for the duration of the study),
    - treatment with any investigational drug in the last 30 days,
    - symptomatic coronary heart disease,
    - impaired renal function (creatinin clearance < 60 ml/min/m2),
    - hepatic disease other than steotosis hepatis,
    - an active malignancy other than basal cell skin carcinoma,
    - previous treatment with GLP-1 receptor agonists (including liraglutide or exenatide) within the last 3 months,
    - use any other medication for the treatment diabetes than metformin (e.g. TZD, SU, DPP-IV inhibitors, insulin). If considered appropriate on the basis of glycemic regulation this medication can be stopped, thereby making patients eligible for the study.
    - have experienced hypersensitivity reaction or a worsening of glycemic control on GLP-1 receptor agonists (including liraglutide or exenatide),
    - a history of Major Depressive Disorder within the last 2 years,
    - a history of other severe psychiatric disorders, e.g., schizophrenia, bipolar disorder,
    - a PHQ-9 score of ≥ 15,
    - any lifetime history of a suicidal attempt,
    - in the opinion of the investigator, patient is abusing alcohol and/or drugs,
    - screening calcitonin ≥ 50 ng/L,
    - a family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC),
    - a personal history of non-familial medullary thyroid carcinoma,
    - a history of chronic pancreatitis or idiopathic acute pancreatitis.
    - Insufficient mental capacity in the opinion of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    1. Glycemic variability (glucose SD, Mean Amplitude of Glucose Excursions (MAGE), 24 hour glycemic variation) as measured by blinded CGM,
    2. Glycemic control (SMBG and HbA1c, time spend in hyper- and hypoglycaemia, 1.5-anhydroglucitol),
    3. Glucose peak and nadir after a Mixed Meal Tolerance Test (MMTT).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline to day before operation and to 52 weeks post-operation.
    E.5.2Secondary end point(s)
    Change from baseline to day before operation and to 52 weeks post-operation in
    1. percentage body weight, absolute body weight, and excess BMI.
    2. Cardiovascular risk profile: waist circumference, systolic and diastolic blood pressure, hsCRP, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, urinary albumin-creatinin ratio, medication for hypertension and dyslipidemia.
    3. Insulin, incretins and other gut hormones after an MMTT.
    4. Quality of Life (SF-36), Dumping syndrome score, Eating behavior (Dutch Eating Behaviour Questionnaire).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from baseline to day before operation and to 52 weeks post-operation.
    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 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
    LVLS
    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 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: 60
    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 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 state60
    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)
    None
    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 Decision2014-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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