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    Summary
    EudraCT Number:2019-004222-22
    Sponsor's Protocol Code Number:U1111-1235-6899
    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:2019-12-10
    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 number2019-004222-22
    A.3Full title of the trial
    Adjustment of insulin Degludec to Reduce post-Exercise (nocturnal) hypoglycaeMia in people with diabetes – the ADREM study
    Aanpassing van insuline Degludec om (nachtelijke) hypoglykemie na inspanning te verminderen bij patiënten met diabetes - de ADREM studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adjustment of the dose of long acting insulin (Degludec) to reduce low glucose after exercise in patients with type 1 diabetes
    Aanpassing van de dosis langwerkende insuline (Degludec) om lage bloedsuikerwaarden na inspanning te verminderen bij patiënten met type 1 suikerziekte
    A.3.2Name or abbreviated title of the trial where available
    ADREM
    ADREM
    A.4.1Sponsor's protocol code numberU1111-1235-6899
    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 SponsorRadboud University Medical Center
    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.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Medical Center
    B.5.2Functional name of contact pointresearch physician
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31243618819
    B.5.6E-mailevertine.abbink@radboudumc.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 Tresiba
    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 nameInsulin Degludec
    D.3.2Product code EU/1/12/807/001
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    type 1 diabetes mellitus
    type 1 diabetes mellitus
    E.1.1.1Medical condition in easily understood language
    type 1 diabetes mellitus
    type 1 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 investigate the effect of three degludec dosing regimens on the risk of post-exercise nocturnal hypoglycaemia (time spent in glucose range ≤3.8 mmol/l, 00:00 to 05:59h) in type 1 diabetes mellitus patients at elevated risk of hypoglycaemia.
    Onderzoek naar het effect van drie degludec doseringsschema's op het risico op nachtelijke hypoglykemieën (tijd in glucose range ≤3.8 mmol/l, 00:00 tot 05:59h) bij patiënten met type 1 diabetes mellitus met verhoogd risico op hypoglycemie.
    E.2.2Secondary objectives of the trial
    To investigate the effect of three post-exercise degludec dosing regimens on:
    - Time spent in nocturnal hyperglycaemia
    - Number of nocturnal hypoglycaemic events
    - Number of serious hypoglycaemic events (in the 6 days following exercise)
    - Number of severe hypoglycaemic events (in the 14 days following exercise)
    - Total number of hypoglycaemic events (in the 6 days following exercise)
    Onderzoek naar het effect van drie degludec doseringsschema's op:
    - Tijd in nachtelijke hypoglykemie
    - Aantal nachtelijke hypoglykemieën
    - Aantal ernstige (serious) hypoglykemieën (in de 6 dagen na de inspanning)
    - Aantal ernstige (severe) hypoglykemieën (in de 14 dagen na de inspanning)
    - Totaal aantal hypoglykemieën (in de 6 dagen na de inspanning)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adults with type 1 diabetes mellitus, 18-60 years
    • Diabetes duration at least two years
    • Treatment with long-acting insulin in combination with short-acting insulin analogue, according to basal-bolus regimen for at least one year
    • Stable glycaemic control with HbA1c ≤75 mmol/mol (9%)
    • At least one severe hypoglycaemia in the past year and/or ≥2 points on Dutch modified version of Clarke score or ≥3 points on Gold score
    • Regularly engaging in exercise of moderate intensity or more (at least one hour per week)
    • Volwassenen met type 1 diabetes mellitus, 18-60 jaar
    • Diabetesduur minimaal twee jaar
    • Behandeling met langwerkende insuline in combinatie met kortwerkende insuline volgens basaal-bolus schema gedurende minimaal één jaar
    • Stabiele glucosecontrole met HbA1c ≤75 mmol/mol (9%)
    • Minimaal één ernstige hypoglykemie in het afgelopen jaar en/of ≥2 punten in de Nederlandse gemodificeerde versie van de Clarke score of ≥3 punten op de Gold score
    • Regelmatig minimaal matige inspanning (minimaal één uur per week)
    E.4Principal exclusion criteria
    • Microvascular complications, except background retinopathy or microalbuminuria
    • History of cardiovascular disease, including heart failure, symptomatic cardiac valve disease and treatment-requiring arrhythmia
    • Use of drugs affecting glucose metabolism other than insulin or metformin
    • BMI >30 kg/m2
    • Blood pressure >160/90 mmHg or use of blood pressure lowering drugs
    • Pregnancy or the wish to become pregnant
    • MDRD-GFR <60 ml/min/1.73 m2
    • Microvasculaire complicaties, behalve achtergrond retinopathie of microalbuminurie
    • Voorgeschiedenis van hart-vaatziekten, inclusief hartfalen, symptomatische hartklepaandoening en arrhythmie die behandeling behoeft
    • Gebruik van geneesmiddelen die het glucosemetabolisme beïnvloeden anders dan insuline of metformine
    • BMI >30 kg/m2
    • Bloeddruk >160/90 mmHg of gebruik van antihypertensiva
    • Zwangerschap of de wens zwanger te worden
    • MDRD-GFR <60 ml/min/1.73 m2
    E.5 End points
    E.5.1Primary end point(s)
    Time spent in hypoglycaemic range (i.e. glucose ≤3.8 mmol/l) during the night (00:00 to 05:59h) following the exercise day measured by continuous glucose monitoring.
    Tijd in hypoglykemische range (i.e. glucose ≤3.8 mmol/l) gedurende de nacht (00:00 tot 05:59h) volgend op de inspanning gemeten met continue glucose monitoring
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of each treatment period
    Aan het eind van elke behandelingsperiode
    E.5.2Secondary end point(s)
    • Time spent in hyperglycaemic range during the night (00:00 to 05:59h) following the exercise day measured by CGM
    • Number of nocturnal hypoglycaemic events during the night (00:00 to 05:59h) following the exercise day measured by CGM
    • Number of serious hypoglycaemic events during the 6 days following the exercise day measured by CGM
    • Number of severe hypoglycaemic events during the 14 days following the exercise day
    • Total number of hypoglycaemic events during the 6 days following the exercise day measured by CGM
    • Tijd in hyperglykemische range gedurende de nacht (00:00 tot 05:59h) volgend op de inspanning gemeten met CGM
    • Aantal nachtelijke hypoglykemieën gedurende de nacht (00:00 tot 05:59h) volgend op de inspanning gemeten met CGM
    • Aantal ernstige (serious) hypoglycemieën in de 6 dagen volgend op de inspanning gemeten met CGM
    • Aantal ernstige (severe) hypoglycemieën in de 14 dagen volgend op de inspanning
    • Totaal aantal hypoglykemieën in de 6 dagen volgend op de inspanning gemeten met CGM
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of each treatment period
    Aan het eind van elke behandelingsperiode
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Same medicinal product in other dosing regimen
    E.8.2.4Number of treatment arms in the trial3
    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
    LSLV
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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: 18
    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 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 state18
    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)
    Subject to the patient’s preference, patients will return to their prestudy diabetes treatment or may wish to continue treatment with insulin degludec at the end of the study.
    Afhankelijk van de voorkeur van de patiënt, zal de patiënt na afloop van de studie herstarten met de medicatie die voorafgaand aan de studie werd gebruikt of doorgaan met insuline degludec.
    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 Decision2019-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-02
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