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    Summary
    EudraCT Number:2018-004245-16
    Sponsor's Protocol Code Number:NL67646.068.18
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-13
    Trial results View 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 number2018-004245-16
    A.3Full title of the trial
    Targeting the beta-2 adrenergic pathway to improve skeletal muscle glucose uptake in healthy humans
    Activatie van het beta-2 adrenerge pathway in gezonde mensen om de glucose opname door de spier te verbeteren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of a new way for sugar uptake by the skeletal muscle.
    Onderzoek naar een nieuwe manier van suiker opname door de spier
    A.3.2Name or abbreviated title of the trial where available
    Beta-2 study
    Beta-2 studie
    A.4.1Sponsor's protocol code numberNL67646.068.18
    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 supportZonMW & the Dutch Diabetes Research Foundation
    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 pointClinicaltrials.gov
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitssingel 50
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229ER
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310433884254
    B.5.6E-mailSten.vanbeek@maastrichtuniversity.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 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 nameClenbuterol hydrochloride
    D.3.4Pharmaceutical form Capsule
    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 INNCLENBUTEROL
    D.3.9.1CAS number 37148-27-9
    D.3.9.2Current sponsor codeCurrently unknown
    D.3.9.3Other descriptive nameCurrently unknown
    D.3.9.4EV Substance CodeSUB06651MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral 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
    Type 2 diabetes
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Suikerziekte
    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
    To determine if prolonged treatment with the selective beta-2-adrenergic agonist clenbuterol improves skeletal muscle glucose disposal via the mTORC2 pathway in lean, healthy male individuals with normal physical activity.
    Om te onderzoeken of supplementatie met de selective beta-2 agonist clenbuterol voor een langere tijd de glucose opname in de spier verbetert via de mTORC2 pathway in slanke, gezonde mannen met normale fysieke activiteit.
    E.2.2Secondary objectives of the trial
    Does acute (4 hours) and prolonged (2 weeks) administration with the selective beta-2-adrenergic agonist clenbuterol enhance skeletal muscle GLUT4 translocation via the mTORC2 pathway?
    Doet acute (4 uur) en langere (2 weken) inname met van selectieve beta-2 adrenerge agonist clenbuterol de GLUT4 translocatie verhogen in de spier via de mTORC2 pathway
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Caucasian;
    2. Male sex;
    3. Age: 18-30 years
    4. BMI: 20-25 kg/m2;
    5. Normal physical activity levels;
    1. Kaukasisch
    2. Mannelijke geslacht
    3. Leeftijd: 18-30 jaar
    4. BMI: 20-25 kg/m2
    5. Normale fysieke activiteit levels
    E.4Principal exclusion criteria
    1. Not meeting all inclusion criteria
    2. Cardiovascular disease (determined by means of questionnaires, heart rate/blood pressure measurements);
    3. Respiratory diseases (including asthma, bronchitis and COPD);
    4. Unstable body weight (weight gain or loss > 5 kg in the last three months);
    5. Intention to lose or gain body weight (e.g. with caloric restriction or physical activity)
    6. Excessive alcohol and/or drug abuse;
    7. Hypokalaemia;
    8. Anaemia;
    9. Epilepsy;
    10. Smoking;
    11. Renal and/or liver insufficiency;
    12. Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;
    13. Medication use known to hamper subject’s safety during the study procedures; 

    14. Subjects who do not want to be informed about unexpected medical findings; 

    15. Subjects who do not want that their treating physician to be informed;
    16. Inability to participate and/or complete the required measurements;
    17. Participation in organised or structured physical exercise;
    18. Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk;
    19. Hyperthyroidism
    1. Niet voldoen aan alle inclusie criteria
    2. Cardiovasculaire aandoeningen (gebaseerd op vragenlijsten, hartslag/bloeddruk metingen)
    3. Luchtwegaandoeningen
    4. Onstabiel lichaamsgewicht (gewichtstoename of afname >5 kg in de laatste drie maanden)
    5. Intentie om gewicht bij te komen of af te vallen (bijvoorbeeld door een dieet of verhoogde fysieke activiteit)
    6. Overmatige alcohol/drugs consumptie
    7. Hypokaliëmie
    8. Anemie
    9. Epilepsie
    10. Roken
    11. Nier en/of lever insufficientie
    12. Proefpersonen die hebben meegedaan aan een andere biomedische studie binnen 1 maand voor het eerste bezoek, daarbij mogelijk de studie resultaten beïnvloeden
    13. Medicatie die bekend is de proefpersoon zijn veiligheid kan beïnvloeden gedurende de studie procedures
    14. Proefpersonen die niet op de hoogte willen worden gesteld van onverwachte medische bevindingen.
    15. Proefpersonen die niet willen dat hun eigen huisarts wordt geïnformeerd
    16. Proefpersonen waarvoor het niet mogelijk is om de metingen te doen/ de metingen af te maken.
    17. Proefpersonen die deelnemen aan georganiseerde/gestructureerde fysieke activiteiten
    18. Enige conditie, ziekte or abnormale testwaarden die, volgens de onderzoeker, de studie uitkomsten kunnen beïnvloeden of de proefpersoon in risico brengen.
    19. Hyperthyreoïdie
    E.5 End points
    E.5.1Primary end point(s)
    Insulin-stimulated peripheral glucose disposal (Rd) during the high-insulin infusion of the two-step hyperinsulinemic-euglycemic clamp
    E.5.1.1Timepoint(s) of evaluation of this end point
    After finalising the second intervention period of the 11th subject
    E.5.2Secondary end point(s)
    Skeletal muscle GLUT4 translocation
    E.5.2.1Timepoint(s) of evaluation of this end point
    After finalising the second intervention period of the 11th subject
    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
    IMP is used to investigate whether selective beta-2 adrenergic agonist stimulation enhances skeletal muscle glucose uptake through the mTORC2-GLUT4 pathway
    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 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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    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: 16
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 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)
    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 Decision2019-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-23
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