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    Summary
    EudraCT Number:2019-003771-19
    Sponsor's Protocol Code Number:2019-100
    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:2019-10-02
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-003771-19
    A.3Full title of the trial
    The effect of improved insulin sensitivity on bone turnover markers and bone biomechanical properties in persons with type 2 diabetes mellitus
    Effekten af øget insulinfølsomhed på knoglemarkører og knoglers biomekaniske egenskaber hos personer med type 2 diabetes mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    How improved sensitivity to insulin affects bone health in persons with type 2 diabetes
    Hvordan øget følsomhed for insulin påvirker knoglernes helbred hos personer med type 2 diabetes
    A.3.2Name or abbreviated title of the trial where available
    METCERCISE
    A.4.1Sponsor's protocol code number2019-100
    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 SponsorAarhus Universitetshospital
    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 supportNovo Nordisk Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus Universitetshospital
    B.5.2Functional name of contact pointSteno Diabetes Center Aarhus
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Blvd. 99
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.6E-mailzheer@clin.au.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 Mitforgen (Metformin)
    D.2.1.1.2Name of the Marketing Authorisation holderMylan
    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 Tablet
    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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.1CAS number 1115-70-4
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboTablet
    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 mellitus
    Diabetic bone disease
    Type 2 diabetes mellitus
    Diabetisk knoglesygdom
    E.1.1.1Medical condition in easily understood language
    Diabetes (type 2)
    Bone health in diabetes
    Sukkersyge / diabetes (type 2)
    Knoglers helbred i diabetes
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    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
    To investigate whether improved insulin sensitivity (by training and/or metformin use) in diabetics leads to increased bone turnover and bone reparation.
    At undersøge hvorvidt forbedret insulinfølsomhed hos diabetikere (opnået ved træning og eller metforminbehandling) medfører øget knogleturnover og knoglereparation.
    E.2.2Secondary objectives of the trial
    To investigate whether improved insulin sensitivity (by training and/or metformin use) in diabetics leads to improved bone biomechanical properties (bone structure), bone marrow turnover, and changes in fat tissue and body composition.
    At undersøge hvorvidt forbedret insulinfølsomhed hos diabetikere (opnået ved træning og eller metforminbehandling) medfører forbedrede biomekaniske egenskaber i knogle (knoglestruktur), øget turnover målt i knoglemarven samt ændringer i fedtvæv og kropssammensætning.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosed type 2 diabetes mellitus
    Alder ≥ 45 years
    Male gender OR female gender and postmenopausality
    Diagnosticeret type 2 diabetes mellitus
    Alder ≥ 45 år
    Mandligt køn ELLER kvindeligt køn og overstået menopause
    E.4Principal exclusion criteria
    Current or previous treatment with other antidiabetics than metformin
    Premature menopause (menopause before 40 years of age)
    Treatment with systemic glucocorticoids within 2 years
    Treatment with antiresorptive or bone anabolic drugs (ever)
    Lithium treatment (ever)
    Anticonvulsive treatment (ever)
    Current menopausal hormone replacement therapy
    eGFR < 60 ml/min
    Significant cardiovascular, endocrinological, renal, hepati, rheumatological, gastrointestinal or other illness
    Osteoporosis or other bone disease
    D-vitamine deficiency
    Recent bone fractures (6 months)
    Previous fractures in both ankles (tibia) or both wrists (radius)
    Active cancer within previous 5 years or other unstable medical illness
    Assessed inability to participate in trial-related interventions or examinations
    Allergy to relevant pharmaceuticals
    • HbA1c ≥ 90 mmol/mol
    • Præmatur menopause (menopause tidligere end 40-års-alderen)
    • Aktuel eller tidligere behandling med andre antidiabetika end metformin
    • Behandling med følgende lægemidler:
    o - Systemiske glukokortikoider (indenfor de seneste 2 år)
    o - Antiresorptive eller knogleanabole lægemidler (nogensinde)
    o - Litium (nogensinde)
    o - Antikonvulsiva (aktuelt)
    o - Menopausal hormonterapi (aktuelt)
    • Estimeret glomerulær filtrationsrate (eGFR) < 60 ml/min
    • Betydende kardiovaskulær, endokrinologisk, renal, hepatisk, rheumatologisk, gastrointestinal eller anden lidelse vurderet af investigator
    • Osteoporose eller anden knoglesygdom
    • Nylige knoglebrud (6 måneder)
    • Tidligere knoglebrud i enten begge ankler (tibia) eller begge håndled (radius)
    • Parathyroidea- eller calciummetaboliske lidelser
    • D-vitaminmangel (< 50 nmol/L)
    • Anden betydende medicinsk sygdom i ustabil fase eller aktiv cancersygdom indenfor de seneste 5 år, undtaget spino- eller basocellulær carcinom
    • Allergi overfor et af indholdsstofferne i forsøgsmedicinen
    • Manglende evne til at gennemføre træningsinterventionen
    E.5 End points
    E.5.1Primary end point(s)
    Bone turnover markers in blood
    Knogleturnovermarkører målt i blodet
    E.5.1.1Timepoint(s) of evaluation of this end point
    12-13 weeks
    12-13 uger
    E.5.2Secondary end point(s)
    Bone biomechanical properties (assessed by HRpQCT-scan)
    Bone marrow levels of bone turnover
    Body composition
    Fat tissue expression levels of metabolism-related genes and proteins
    Insulin sensitivity (measured as steady-state plasma glucose by insulin suppression test)
    Knoglers biomekaniske egenskaber (målt ved HRpQCT-skanning)
    Knoglemarvsniveauer af knogleturnover
    Kropssammensætning
    Fedtvævs ekspression af metabolismerelaterede gener og proteiner
    E.5.2.1Timepoint(s) of evaluation of this end point
    12-13 weeks
    12-13 uger
    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 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 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 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 trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    June 2022
    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 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: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    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 state104
    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
    Ingen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-10-13
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