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    Summary
    EudraCT Number:2018-001569-17
    Sponsor's Protocol Code Number:T1DM_IAH_dapa
    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:2018-08-15
    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 number2018-001569-17
    A.3Full title of the trial
    Effect of the SGLT-2 inhibitor dapagliflozin on impaired awareness of hypoglycemia in type 1 diabetes
    Effect van de SGLT-2 remmer dapagliflozine op verminderde hypoglykemie symptoomgewaarwording (awareness) bij mensen met type 1 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To investigate whether treatment with the SGLT-2 inhibitor dapagliflozin improves the perception of hypoglycemia in people with type 1 diabetes with impaired awareness of hypoglycemia
    Het effect van behandeling met de SGLT-2 remmer dapagliflozine op verminderde hypoglykemie symptoomgewaarwording (awareness) bij mensen met type 1 diabetes die hypo's niet (goed) voelen
    A.3.2Name or abbreviated title of the trial where available
    Dapagliflozin and impaired awareness of hypoglycemia in T1DM
    Dapagliflozine en verminderde hypoglylemie awareness in T1DM
    A.4.1Sponsor's protocol code numberT1DM_IAH_dapa
    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 supportRadboud university medical Center
    B.4.2CountryNetherlands
    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 pointLian van Meijel
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein-Zuid 8
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31243610846
    B.5.6E-mailLian.vanMeijel@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 Dapagliflozin 10 milligram
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameDapagliflozin
    D.3.4Pharmaceutical form Film-coated 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 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 1 diabetes
    Type 1 diabetes
    E.1.1.1Medical condition in easily understood language
    Diabetes, Sugar disease
    Suikerziekte
    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 investigate the effect of treatment with the SGLT-2 inhibitor dapagliflozin on the
    awareness of and counterregulatory hormone responses to
    hypoglycemia in people with type 1 diabetes and impaired
    hypoglycemic awareness
    Onderzoeken van effect van behandeling met de SGLT-2 remmer dapagliflozine op de symptomatologie van en hormonale respons op
    hypoglykemieën bij patiënten met type 1 diabetes en verminderde
    hypoglykemie awareness (IAH, impaired awareness of hypoglycemia)
    E.2.2Secondary objectives of the trial
    To investigate the effect of treatment with the SGLT-2 inhibitor dapagliflozin on the
    glycemic recovery from hypoglycemia and the post-hypoglycemic
    glucose excursion in people with type 1 diabetes and impaired awareness of hypoglycemia
    Onderzoeken van effect van behandeling met de SGLT-2 remmer dapagliflozine op het glucoseherstel en de mate van glucosestijging na
    hypoglykemie bij patiënten met type 1 diabetes en verminderde
    hypoglykemie awareness
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Type 1 diabetes, disease duration >1 year
    • Age >18 years, <75 years
    • BMI 19-30 kg/m^2
    • Insulin treatment according to basal-bolus insulin regimen (injections
    or insulin pump)
    • Impaired awarenessof hypoglycemia as assessed by a score of 3 or
    more on the modified Dutch translation of the Clarke questionnaire
    • Glycated haemoglobin (HbA1c) ≥42 mmol/mol (6%) and ≤75
    mmol/mol (9.0%)
    • Ability to provide informed consent
    • Type 1 diabetes met een duur van tenminste 1 jaar
    • Leeftijd ouder dan 18 jaar en jonger dan 75 jaar
    • BMI tussen 19-30 kg/m^2
    • Insulinebehandeling volgens het zg. basaal-bolus principe met
    injecties of een subcutane pomp
    • Impaired awareness of hypoglycemia gedefinieerd als tenminste 3
    punten (van max. 5) op de in het Nederlands vertaalde IAH-vragenlijst
    van Clarke
    • HbA1c ≥42 mmol/mol (6%) en ≤75 mmol/mol (9.0%)
    • Voldoende in staat om informed consent te geven
    E.4Principal exclusion criteria
    • Known intolerance to SGLT-2 inhibitors (including allergy)
    • Treatment with glucose-modefying or immune-modefying agents, e.g.
    prednisolon
    • Treatment with pioglitazone
    • History of cardiovascular disease (e.g. myocardial infarction, stroke, heart failure, symptomatic peripheral arterial disease) or hypotension
    • Conditions that can lead to volume depletion (acute gastro-intestinal diseases)
    • History of galactose-intolerance, lactase deficiency, glucose-galactose malabsorption
    • History of diabetic ketoacidosis requiring medical intervention within 1 month before screening
    • Admission to the hospital for hyper- or hypoglycemia <1 month before screening
    • Frequent episodes of severe hypoglycemia <1 month before screening
    • History of laser coagulation for proliferative
    retinopathy (past 6 months)
    • Proliferative retinopathy
    • Symptomatic diabetic neuropathy
    • Diabetic nephropathy as reflected by albumin-creatinin ratio >30
    mmol/mg or MDRD <60 ml/min/1.73 m2
    • History of pancreatitis (acute or chronic) or pancreatic cancer
    • Use of premixed insulin or of long-acting insulin alone
    • Total daily insulin dose requirements <20 units unless on pump
    treatment
    • Pregnancy or unwillingness to undertake measures for birth control
    • Bekende intolerantie of allergie voor SGLT-2 remmers
    • Behandeling met pioglitazon
    • Behandeling met medicijnen die invloed hebben op het glucosemetabolisme of immuunsysteem, zoals prednisolon
    • Voorgeschiedenis van een hart- en vaatziekten (bijvoorbeeld myocardinfarct, beroerte, hartfalen, perifeer arterieel vaatlijden) of hypotensie
    • Bekend met aandoeningen die kunnen leiden tot volume depletie (acute gastro-intestinale ziekte)
    • Voorgeschiedenis van galactose-intolerantie, lactase deficiëntie, glucose-galactose malabsorptie
    • Voorgeschiedenis van diabetische ketoacidose waarvoor medische interventie noodzakelijk was <1 maand voor screening
    • Ziekenhuisopname voor hyper- of hypoglykemie <1 maand voor screening
    • Frequente episodes van ernstige hypoglykemie <1 maand voor screening
    • Voorgeschiedenis van laserbehandeling voor proliferatieve retinopathie in de afgelopen 6 maanden
    • Proliferatieve retinopathie
    • Symptomatische diabetische neuropathie
    • Diabetische nefropathie, weerspiegeld door een albumine-kreatine ratio van >30 mmol/mg en/of een MDRD <60 ml/min/1.73 m2
    • Voorgeschiedenins van pancreatitis (acuut of chronisch) of pancreaskanker
    • Gebruik van voorgemixt insuline of behandeling met alleen langwerkend insuline
    • Totale insulinebehoefte van minder dan 20 eenheden per dag, tenzij behandeld met een insulinepomp
    • Zwangerschap of niet bereid tot het gebruiken van voorbehoedsmiddelen
    E.5 End points
    E.5.1Primary end point(s)
    Maximal symptom score in response to hypoglycemia during the hyperinsulinemic
    hypoglycemic glucose clamp experiment
    Maximale symptoomscore tijdens hypoglykemie gedurende het hyperinsulinemische
    hypoglykemische glucose clamp experiment
    E.5.1.1Timepoint(s) of evaluation of this end point
    During hypoglycemic glucose clamp after 8 weeks of treatment
    Gedurende de hypoglykemische glucose clamp na 8 weken behandeling
    E.5.2Secondary end point(s)
    - Responses of counterregulatory hormones ((nor)adrenaline, glucagon,
    cortisol, growth hormone) to the hyperinsulinemic hypoglycemic
    glucose clamp
    - Time until glycemic recovery from hypoglycemia after the
    hyperinsulinemic glucose clamp
    - Maximal glucose excursion post-hypoglycemia after the
    hyperinsulinemic glucose clamp
    - Time until glucose peak post-hypoglycemia after the hyperinsulinemic
    glucose clamp
    - The inflammatory/atherogenic phenotype of circulating monocytes
    - Area under the glucose concentration curve post-hypoglycaemia after
    the hyperinsulinemic glucose clamp
    - Hunger score post-hypoglycemia after the hyperinsulinemic glucose
    clamp
    - Number of severe hypoglycemic events during 8 weeks of treatment
    with dapagliflozin or placebo
    - Number of nocturnal hypoglycemic events during 8 weeks of
    treatment with dapagliflozin or placebo
    - Number of any hypoglycemic events during 8 weeks of treatment with
    dapagliflozin or placebo
    - Number of hypoglycemic events and time spent under hypoglycemic
    conditions as measured by continuous glucose sensor monitoring
    - Glucose variability as measured by continuous glucose sensor
    monitoring
    - Vital signs during the hyperinsulinemic hypoglycemic glucose clamp
    - Percentage change in total daily insulin dose
    - Percentage change in bodyweight
    - Amount of carbohydrates and calories consumed after hypoglycemia
    HbA1c levels
    - Genitourinary adverse effects during treatment periods
    - Occurrence of diabetic ketoacidosis
    - Respons van de contraregulerende hormonen ((nor)adrenaline, glucagon,
    cortisol en groeihormoon) tijdens het hyperinsulinemische
    hypoglykemische glucose clamp experiment
    - Tijd tot herstel tot normoglykemie na afloop van de
    hyperinsulinemische hypoglykemische glucose clamp
    - Maximale glucosespiegel na afloop van de hyperinsulinemische
    hypoglykemische glucose clamp
    - Tijd tot maximale glucosepiek na afloop van de hyperinsulinemische
    hypoglykemische glucose clamp
    - Totale hyperglykemische belasting vanaf herstel tot normoglykemie
    - Mate van hongergevoel na herstel van hypoglykemie
    - Aantal ernstige hypoglykemieën tijdens 8 weken behandeling met
    dapagliflozine of placebo
    - Aantal nachtelijke hypoglykemieën tijdens 8 weken behandeling met
    dapagliflozine of placebo
    - Totaal aantal ernstige en niet-ernstige hypoglykemieën tijdens 8
    weken behandeling met dapagliflozine of placebo
    - Aantal hypoglykemieën en tijd in hypoglykemie gemeten met continue
    glucose sensor registratie
    - Glucosevariabiliteit gemeten met continue glucose sensor registratie
    - Vitale kenmerken gemeten tijdens de hyperinsulinemiscpe
    hypoglykemische glucose clamp
    - Percentage verandering in totale dagelijkse insuline dosis
    - Percentage verandering in lichaamsgewicht
    - Hoeveelheid koolhydraten en calorieën geconsumeerd na hypoglykemie
    - HbA1c waarde
    - Frequentie van genitale of urineweginfecties
    - Frequentie van diabetische ketoacidose
    - Inflammatoire en atherogene fenotype van circulerende monocyten
    E.5.2.1Timepoint(s) of evaluation of this end point
    During 8 weeks follow-up or during the hypoglycemic glucose clamp after 8 weeks of treatment
    Tijdens de 8 weken behandeling of gedurende de hypoglykemische glucose clamp na 8 weken behandeling
    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) 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 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
    Laatste visite van de laatste patiënt
    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 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: 15
    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 state15
    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)
    Usual care will resume. There is no possibility to continue study
    medication.
    De gebruikelijke behandeling zal weer worden hervat; er is geen
    mogelijkheid studiemedicatie te continueren.
    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 Decision2018-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-20
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