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    Summary
    EudraCT Number:2020-004929-23
    Sponsor's Protocol Code Number:2020/1002
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-21
    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 number2020-004929-23
    A.3Full title of the trial
    Individual albuminuria lowering response to dapagliflozin in a decentralized
    clinical trial in patients with type 2 diabetes mellitus and elevated albuminuria
    Individuele albuminurie verlagende effecten van dapagliflozine in een gedecentraliseerde klinische trial in patiënten met type 2 diabetes mellitus en verhoogde albuminurie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Individual urinary protein decreasing effects of dapagliflozin in a remote clinical trial in patients with type 2 diabetes mellitus and elevated urinary protein concentrations.
    Individuele effecten van dapagliflozine op de hoeveelheid eiwit in urine in een klinisch onderzoek in de thuissituatie in patiënten met suikerziekte en een verhoogde hoeveelheid eiwit in de urine.
    A.3.2Name or abbreviated title of the trial where available
    @Home study
    @Home studie
    A.4.1Sponsor's protocol code number2020/1002
    A.5.4Other Identifiers
    Name:Netherlands Trial RegisterNumber:NL9060
    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 SponsorUniversity Medical Center Groningen
    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 supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportAstraZeneca
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportDutch Kidney Foundation
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointH.J. Lambers Heerspink
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700 RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31503617859
    B.5.5Fax number+31503617889
    B.5.6E-mailh.j.lambers.heerspink@umcg.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 Forxiga
    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 placeboFilm-coated tablet
    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
    Patients with type 2 diabetes and albuminuria >20 mg/g (2.26 mg/mmol)
    Patiënten met type 2 diabetes en albuminurie >20 mg/g (2.26 mg/mmol)
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    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
    Process: Assessing the feasibility and user-friendliness of remote data collection as well as assessing the experience of patients with remote data collection.

    Clinical trial:
    Primary: Assessing the change in first morning void urine albumin-to-creatinine ratio from start to end of treatment
    Proces:
    Bepalen van de haalbaarheid en gebruiksvriendelijkheid van gegevensverzameling in de thuissituatie, mede als het bepalen van patiëntenervaringen met gegevensverzameling in de thuissituatie.

    Klinische trial:
    Primair: Bepalen van de verandering in albumine:creatinine ratio in eerste ochtendurine van begin tot eind van de behandeling.
    E.2.2Secondary objectives of the trial
    Clinical trial:
    Secondary: Assessing changes from baseline in:
    - Systolic blood pressure
    - Body weight and body composition
    - eGFR
    - Fasting plasma glucose
    Klinische trial:
    Secundair: Bepalen van veranderingen ten opzichte van baseline in:
    - Systolische bloeddruk
    - Lichaamsgewicht en -samenstelling
    - eGFR
    - Nuchter plasma glucose
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years
    - Diagnosis of type 2 diabetes mellitus
    - Urinary albumin-to-creatinine ratio >20 mg/g (2.26 mg/mmol)
    - eGFR >30 ml/min/1.73m2
    - Willing to sign informed consent
    - Leeftijd ≥ 18 jaar
    - Diagnose type 2 diabetes mellitus
    - Urinaire albumine:creatinine ratio >20 mg/g (2.26 mg/mmol)
    - eGFR >30 ml/min/1.73m2
    - Bereid om informed consent te tekenen
    E.4Principal exclusion criteria
    - Diagnosis of type 1 diabetes
    - Prior treatment with SGLT2 inhibitor in the four weeks prior to randomization
    - History of severe hypersensitivity or contraindications to dapagliflozin
    - Unable to monitor blood pressure / body weight or handle digital technologies
    - History of non-adherence to medical regimens or unwillingness to comply with the study protocol
    - Participation in any clinical investigation within 3 months prior to initial dosing
    - Unstable or rapidly progressing renal disease
    - Severe hepatic impairment (Child-Pugh class C) (only when it is known, since the Child-Pugh score is usually not determined in general practice)
    - Active malignancy
    - Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
    o History of active inflammatory bowel disease, within the last six months.
    o Major gastrointestinal tract surgery as decided by the treating physician.
    o Pancreatitis within the last six months.
    o Evidence of serious hepatic disease as determined by the treating physician.
    o Evidence of urinary obstruction or difficulty in voiding at screening.
    - Donation or loss of 400 mL of blood within 8 weeks prior to initial dosing
    - History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening
    - Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
    - (Missing information on) current pregnancy or breast feeding / attempting to conceive.
    - Women of childbearing potential (WOCBP):
    o WOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug in such a manner the risk of pregnancy is minimized.
    o WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent of HCG) within 0 to 72 hours before the first dose of study drug.

    WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal (see definition below). The following women are WOCBP:
    - Women using the following methods to prevent pregnancy: oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as intrauterine devices or barrier methods (diaphragm, condoms, spermicides).
    - Women who are practicing abstinence.
    - Women who have a partner who is sterile (e.g. due to vasectomy).

    Post-menopause is defined as:
    - Women who have had amenorrhea for >12 consecutive months (without another cause) and who have a documented serum follicle-stimulating hormone (FSH) level >35 mIU/mL.
    - Women who have irregular menstrual periods and a documented serum FSH level >35 mIU/mL.
    -Women who are taking hormone replacement therapy (HRT).
    - Diagnose type 1 diabetes
    - Eerdere behandeling met een SGLT2 remmer in de vier weken voorafgaand aan randomisatie.
    - Voorgeschiedenis met ernstige hypersensitiviteit of contra-indicaties voor dapagliflozine.
    - Onvermogen om bloeddruk / gewicht te meten of om te gaan met digitale hulpmiddelen.
    - Gedocumenteerd bewijs van therapieontrouw voor medicatie of onwil om het studieprotocol na te leven.
    - Deelname aan een klinisch onderzoek in de 3 maanden voorafgaand aan de eerste dosis.
    - Instabiele of snel progressieve nierziekte.
    - Ernstige leverinsufficiëntie (Child-Pugh klasse C) (indien bekend want normaliter niet bepaald in de huisartsenpraktijk).
    - Actieve maligniteit
    - Elke medicatie, chirurgische- of medische conditie die de absorptie, distributie, metabolisme of excretie van dapagliflozine significant kunnen veranderen, waaronder (maar niet gelimiteerd tot de volgende):
    o Voorgeschiedenis van actieve inflammatoire darmziekte in de laatste 6 maanden.
    o Uitgebreide gastro-intestinale chirurgie zoals bepaald door de behandelend arts.
    o Pancreatitis in de laatste 6 maanden.
    o Bewijs van leverziekte zoals bepaald door de behandelend arts.
    o Bewijs van een urineobstructie of problemen bij het plassen tijdens screening.
    - Donatie of verlies van >400 mL blood in de 8 weken voorafgaand aan de eerste dosis.
    - Voorgeschiedenis van drugs- of alcoholmisbruik in de 12 maanden voorafgaand aan de eerste dosis, of bewijs van dergelijk misbruik volgens laboratoriumonderzoek uitgevoerd tijdens screening.
    - Elke chirurgische of medische conditie, die volgens de onderzoeker mogelijk leidt tot een hoger risico voor de patiënt bij deelname aan de studie, of er waarschijnlijk toe leidt dat de patiënt niet voldoet aan de onderzoekseisen of de studie voltooit.
    - (Missende informatie over) huidige zwangerschap of borstvoeding / proberen zwanger te worden.
    - Vrouwen die zwanger kunnen worden (WOCBP):
    o WOCBP die geen aanvaardbare anticonceptiemethode willen of kunnen gebruiken om zwangerschap te voorkomen tijdens het onderzoek en tot 4 weken na de laatste dosis van de studiemedicatie op een zodanige manier dat het risico op zwangerschap tot een minimum wordt beperkt.
    o WOCBP moet een negatieve zwangerschapstest in serum of urine hebben (minimale sensitiviteit 25 IU/L of equivalent van HCG) binnen 0 tot 72 uur voor de eerste dosis.

    WOCBP omvat vrouwen bij wie de menarche is opgetreden en die geen succesvolle chirurgische sterilisatie hebben ondergaan (hysterectomie, bilaterale tubale ligatie of bilaterale salpingo-oöphorectomie) of postmenopauzaal zijn (zie definitie hieronder). De volgende vrouwen zijn WOCBP:
    - Vrouwen die de volgende methoden gebruiken om zwangerschap te voorkomen: orale anticonceptiva, andere hormonale anticonceptiva (vaginale producten, huidpleisters of geïmplanteerde/injecteerbare producten) of mechanische producten zoals spiraaltjes, of barrièremethoden (pessarium, condooms, spermiciden).
    - Vrouwen die onthouding toepassen.
    - Vrouwen met een partner die onvruchtbaar is (bijvoorbeeld door vasectomie).

    Postmenopauze wordt gedefinieerd als:
    - Vrouwen met amenorroe voor >12 opeenvolgende maanden (zonder andere oorzaak) en een gedocumenteerde follikel-stimulerend hormoon (FSH) spiegel van >35 mIU/mL.
    - Vrouwen met een onregelmatige menstruatiecyclus en een gedocumenteerde FSH spiegel van >35 mIU/mL.
    - Vrouwen die hormonale substitutietherapie (HST) krijgen.
    E.5 End points
    E.5.1Primary end point(s)
    Process: Feasibility and user-friendliness of remote data collection as well as the experience of patients with remote data collection.

    Clinical trial: Change in first morning void urine albumin-to-creatinine ratio.
    Proces: Haalbaarheid en gebruiksvriendelijkheid van gegevensverzameling in de thuissituatie, mede als patiëntenervaringen met gegevensverzameling in de thuissituatie.

    Klinische trial: Verandering in albumine:creatinine ratio in eerste ochtendurine van begin tot eind van de behandeling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoints will be calculated from start to end of treatment (day 0 to day 63 (week 9)).
    E.5.2Secondary end point(s)
    Changes from baseline in systolic blood pressure, body weight and body composition, eGFR, fasting plasma glucose
    Veranderingen ten opzichte van baseline in: systolische bloeddruk, lichaamsgewicht en -samenstelling, eGFR, nuchter plasma glucose
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints will be calculated from start to end of treatment (day 0 to day 63 (week 9)).
    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 Yes
    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 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
    End of the trial is defined as the last visit of the last subject.
    Einde van de studie is gedefinieerd als de laatste visite van de laatste deelnemer.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    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)
    Patients with type 2 diabetes who respond to dapagliflozin as determined by this study can continue to be treated with dapagliflozin.
    Patiënten met diabetes die positieve effecten ondervinden van dapagliflozine zoals bepaald door deze studie kunnen doorgaan met het gebruik van dapagliflozine.
    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 Decision2020-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-14
    P. End of Trial
    P.End of Trial StatusOngoing
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