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    Summary
    EudraCT Number:2017-003124-73
    Sponsor's Protocol Code Number:na
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-08-29
    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 number2017-003124-73
    A.3Full title of the trial
    Carnitine supplementation as a therapy to improve insulin sensitivity in Type 2 diabetic patients with low carnitine status
    Carnitine supplementatie als therapy om insulin gevoeligheid te verbeteren in type 2 diabetes patienten met een lage carnitine status
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Carnitine supplementation in type 2 diabetic patients
    Carnitine supplementatie in type 2 diabetes patienten
    A.3.2Name or abbreviated title of the trial where available
    Carnitine supplementation and insulin sensitivity
    Carnitine supplementatie en insuline gevoeligheid
    A.4.1Sponsor's protocol code numberna
    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 SponsorMaastricht University
    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 supportNutrim
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University
    B.5.2Functional name of contact pointNutrim
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitssingel 50
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6226ER
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031433881476
    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 Carnitene
    D.2.1.1.2Name of the Marketing Authorisation holderSigma-Tau Pharmaceuticals
    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 nameCarnitene
    D.3.4Pharmaceutical form Chewable tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Glucose tolerance
    glucose tolerantie
    E.1.1.1Medical condition in easily understood language
    Glucose tolerance: the switch between fatoxidation in the fasted state and glucose oxidation in the fed state.
    Glucose tolerantie : het kunnen wisselen tussen vetverbranding in de gevaste staat en suikerverbranding in de gevoede staat. E
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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
    The primary objectives are to investigate whether L-carnitine supplementatiion improves insulin insulin sensitivity and metabolic flexibility in type 2 diabetic patients with a low carnitine status.
    Om te onderzoeken of carnitine supplementatie insuline gevoeligheid en metabole flexibiliteit verbeterd in type 2 diabetes patienten met een lage carnitine status.
    E.2.2Secondary objectives of the trial
    To examine the effects of carnitine supplementation on intrahepatic lipid, body composition, sleep quality, quality of life, physical performance, cognition, acetylcarnitine formation, CrAT activity, acylcarnitine profiles and lipid profiles in type 2 diabetic patients with a low carnitine status
    Om het effect te onderzoeken van carnitine supplementatie in type 2 diabetes patient met een lage carnitine status op levervet, lichaamssamenstelling, kwaliteit van slaap, kwaliteit van leven, conditie, geheugen, acetylcarnitine vorming, CrAT activiteit, acylcarnitine profielen en vetprofielen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and woman
    • Age: 40-70 years
    • Woman should be postmenopausal
    • BMI: 25-35 kg/m2
    • Stable dietary habits
    • No use of medication interfering with investigated study parameters (as determined by responsible physician)
    • Use of oral glucose lowering medication (metformin only or in combination with sulfonylurea agents)
    Mannen en vrouwen
    • Leeftijd: 40-70 jaar
    • Vrouwen moeten post-menopausaal zijn
    • BMI: 25-35 kg/m2
    • Stabiel eetpatroon
    • Geen medicatiegebruik dat interfereert met de uitkomstmaten - gebruik van orale glucose medicatie
    E.4Principal exclusion criteria
    • Haemoglobin levels < 7.8 mmol/L • Uncontrolled hypertension • Use of anticoagulants • Insulin dependent type 2 diabetic patients. • No signs of active liver or kidney malfunction. • Engagement in exercise > 3 hours a week • Being vegetarian or vegan (because of altered whole body carnitine status) • Alcohol and/or drug abuse • Unstable body weight (weight gain or loss > 5kg in the last 3 months) • Significant food allergies/intolerances (seriously hampering study meals) • Participation in another biomedical study within 1 month before the first study visit, which would possibly hamper our study results • Medication use known to hamper subject's safety during the study procedures • Subjects with contra-indications for MRI • Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the study • Subjects who do not want to be informed about unexpected medical findings • No signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy
    • Haemoglobine levels < 7.8 mmol/L • Ongecontroleerde hypertensie • Gebruik van bloedverdunners Insuline afhankelijke patienten met type 2 diabetes Nier of leverfalen • Sporten > 3 uur per week • Vegetarisch of veganistisch • Alcohol en/of drugsmisbruik • Onstabiel lichaamsgewicht (gewichtstoename of -afname > 5kg in de afgelopen 3 maanden) • Voedingsallergie of intolerantie • Deelname in een andere biomedische studie binnen 1 maand voor aanvang aan de huidige studie. • Medicatie gebruik dat interfereert met de onderzochte parameters in de studie • Contra-indicaties voor de MRI • Proefpersonen die bloed willen doneren tijdens de studie of binnen 3 maanden voor aanvang van de studie
    • Proefpersonen die niet geïnformeerd willen worden over toevalsbevindingen • Geen actieve diebetes gerelateerd co-morbiditeiten zoals cardiovasculaire ziekten, diebetische voet, neuropathie en retinopatie
    E.5 End points
    E.5.1Primary end point(s)
    2-step hyperinsulinemic euglycemic clamp combined with tracer kinetics and indirect calorimetry:
    - Whole body insulin sensitivity measured as GIR in µmol/kg/min during the stable period of the insulin phase of the clamp.
    - Hepatic insulin sensitivity measured as EGP in µmol/kg/min.
    - Peripheral insulin sensitivity measured as Rd in µmol/kg/min.
    - Metabolic flexibility (delta RER between basal and insulin stimulated state).
    Insuline gevoeligheid van het hele lichaam weergegeven als GIR in µmol/kg/min tijdens de stabiele fase van de insuline tijdens de clamp.
    hepatische insuline gevoeligheid als EGP in µmol/kg/min
    Perifere insuline gevoeligheid als Rd in µmol/kg/min
    Metabole flexibiliteit ( delta RER tussen basaal en insuline) E
    E.5.1.1Timepoint(s) of evaluation of this end point
    After finilizing the study, meaning 36 included subjects
    Na afronding van de studie. Dus nadat 36 personen
    E.5.2Secondary end point(s)
    - Maximal acetylcarnitine concentrations after exercise (measured using the 1H-MRS cycling measurement)
    - Intrahepatic lipid content (measured using 1H-MRS)
    - Body composition (Bodpod)
    - Metabolites in the blood before (i.e. glucose, free fatty acids, triglycerides, cholesterol, insulin)
    - CrAT activity (measured in muscle biopsies)
    - Acylcarnitine profiles (measured in muscle biopsies)
    - Lipid and lipid intermediates (measured in muscle biopsies)
    - Functional markers of physical performance
    - Quality of life - Quality of sleep
    - Maximal acetylcarnitine concentrie na inspanning
    - Levervet
    - Lichaamssamenstelling
    - Metabolieten in het bloed (glucose, vrije vetzuren, triglyceriden, cholesterol, insuline)
    - CrAT activiteit
    - Acylcarnitine profielen
    - Lipiden - Fysieke vermogen
    - Kwaliteit van slaap
    - Kwaliteit van leve
    E.5.2.1Timepoint(s) of evaluation of this end point
    After finilizing the study, meaning 36 included subjects
    Na afronding van de studie. Dus nadat 36 personen
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    LVLS
    LVLS
    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 days0
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state36
    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
    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 Decision2017-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-11-11
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