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    The EU Clinical Trials Register currently displays   37959   clinical trials with a EudraCT protocol, of which   6229   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-000804-24
    Sponsor's Protocol Code Number:D1690C00024
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-17
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-000804-24
    A.3Full title of the trial
    A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III study to Evaluate the Glycemic Efficacy and Renal Safety of dapagliflozin in patients with Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) who have Inadequate Glycemic Control
    Wieloośrodkowe, prowadzone w grupach równoległych z zastosowaniem metodyki podwójnie ślepej próby i randomizacji, kontrolowane placebo badanie III fazy oceniające skuteczność kontroli glikemii i bezpieczeństwo dla funkcji nerek, zastosowania dapagliflozyny u pacjentów z rozpoznaniem cukrzycy typu 2 i umiarkowaną niewydolnością nerek (Przewlekła Choroba Nerek w stopniu 3A) oraz niewystarczającą kontrolą glikemii
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effect of dapagliflozin on blood glucose level and renal safety in patients with Type 2 Diabetes
    Badanie oceniające wpływ dapaglifozyny na stężenie glukozy we krwi i bezpieczeństwo funkcji nerek u pacjentów z cukrzycą typu 2.
    A.4.1Sponsor's protocol code numberD1690C00024
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02413398
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/310/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsor AstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support AstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@astrazeneca.com
    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 AuthorisationEuropean Union
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDapagliflozin
    D.3.9.1CAS number 960404-48-2
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
    D.3.9.4EV Substance CodeSUB90205
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Type 2 Diabetes Mellitus with Moderate Renal Impairment (CKD 3A)
    Cukrzyca typu 2 z umiarkowanym upośledzeniem nerek (CKD 3A)
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Cukrzyca
    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 compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes and CKD stage 3A.
    Porównanie średniej zmiany w stosunku do wartości wyjściowych stężenia HbA1c pomiędzy dapagliflozyną w dawce 10 mg a placebo po 24 tygodniach doustnego podawania leków metodą podwójnie ślepej próby u pacjentów z cukrzycą typu 2 i z CKD w stadium 3A.
    E.2.2Secondary objectives of the trial
    1, To compare the percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.
    2, To compare the change from baseline in fasting plasma glucose (FPG) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.
    3, To compare the change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.
    1.Porównanie procentowej zmiany w stosunku do wartości wyjściowych całkowitej masy ciała pomiędzy dapagliflozyną w dawce 10 mg a placebo po 24 tygodniach doustnego podawania leków metodą podwójnie ślepej próby.
    2.Porównanie zmiany w stosunku do wartości wyjściowych stężenia glukozy w osoczu na czczo (FPG) pomiędzy dapagliflozyną w dawce 10 mg a placebo po 24 tygodniach doustnego podawania leków metodą podwójnie ślepej próby.
    3.Porównanie zmiany w stosunku do wartości wyjściowych skurczowego ciśnienia tętniczego (SBP) mierzonego u pacjenta w pozycji siedzącej pomiędzy dapagliflozyną w dawce 10 mg a placebo po 24 tygodniach doustnego podawania leków metodą podwójnie ślepej próby.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female or male aged ≥18 years and <75 years.
    2. History of T2DM for more than 12 months.
    3. Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11%.
    4. Stable anti-diabetic treatment regimen.
    5. Renal impairment: CKD 3A.

    1.Mężczyźni i kobiety w wieku ≥ 18 lat i < 75 lat.
    2.Cukrzyca typu 2 (T2DM) od ponad 12 miesięcy.
    3.Niewystarczające wyrównanie glikemii, zdefiniowane jako stężenie HbA1c ≥7,0% i ≤11%.
    4.Stały schemat leczenia przeciwcukrzycowego.
    5.Niewydolność nerek: CKD (przewlekła choroba nerek) 3A.
    E.4Principal exclusion criteria
    1. Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
    2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
    3. Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or Diastolic Blood Pressure (DBP) ≥110 mmHg.
    4. Any of the following Cardiovascular (CV)/Vascular Diseases within 3 months of prior to signing the consent at visit 1:Myocardial infarction, Cardiac surgery or revascularization (CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia.
    5. History of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.
    6. Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency.
    7. Ongoing treatment with any SGLT2-inhibitor or GLP-1 analogue at screening.
    8. Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at visit 1.
    1.Kobiety zdolne do posiadania potomstwa (WOCBP), które nie mogą lub nie są w stanie stosować dopuszczalnej metody zapobiegania zajściu w ciążę przez cały okres badania.
    2.Kwasica ketonowa lub hiperosmolarna śpiączka nieketonowa w wywiadzie.
    3.Ciężkie, niewyrównane nadciśnienie tętnicze, zdefiniowane jako ciśnienie skurczowe ≥180 mmHg i/lub rozkurczowe ≥110 mmHg.
    4.Jakiekolwiek z następujących chorób układu sercowo-naczyniowego/naczyń w okresie 3 miesięcy przed podpisaniem zgody podczas wizyty 1:
    •Zawał serca
    •Operacja kardiochirurgiczna lub rewaskularyzacja (CABG/PTCA)
    •Niestabilna dusznica bolesna
    •Niestabilna niewydolność serca (HF).
    •Niewydolność serca klasy czynnościowej IV wg New York Heart Association [NYHA])
    •Przemijający napad niedokrwienny (TIA) lub istotna choroba naczyń mózgowych
    •Niestabilne lub nierozpoznane wcześniej zaburzenia rytmu serca
    5.Dowolna biopsja lub dowolne badanie obrazowe w wywiadzie, które weryfikowało istnienie dodatkowej choroby nerek (takiej jak kłębuszkowe zapalenie nerek lub objaw zwężenia tętnicy nerkowej), niebędącej wynikiem nefropatii cukrzycowej lub nefropatii cukrzycowej ze stwardnieniem nerek.
    6.Istotna choroba wątroby, w tym w szczególności przewlekłe aktywne zapalenie wątroby i/lub ciężka niewydolność wątroby.
    7.Aktualne leczenie dowolnym inhibitorem SGLT2 lub analogiem GLP-1 podczas oceny przesiewowej.
    8.Udział w innym badaniu klinicznym oceniającym lek badany (IP) w okresie 30 dni przed podpisaniem zgody podczas wizyty 1.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in HbA1c at Week 24
    Zmiana stężenia HbA1c po 24 tygodniach w stosunku do wartości wyjściowej
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to end of treatment
    od wartości wyjściowej do wartości na zakończenie badania
    E.5.2Secondary end point(s)
    1, Percent change from baseline in total body weight at Week 24
    2, Change from baseline in FPG at Week 24
    3, Change from baseline in seated SBP at Week 24
    1. Procentowa zmiana całkowitej masy ciała po 24 tygodniach w stosunku do wartości wyjściowej
    2. Zmiana FPG po 24 tygodniach w stosunku do wartości wyjściowej
    3. Zmiana SBP mierzonego u pacjenta w pozycji siedzącej po 24 tygodniach w stosunku do wartości wyjściowej
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to the end of treatment
    od wartości wyjściowej do wartości na zakończenie badania
    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 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) Yes
    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 Yes
    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 trial2
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Canada
    Czech Republic
    Italy
    Poland
    Spain
    Sweden
    United States
    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
    Last Patient Last Visit
    „LVLS” (Last Visit Last Subject)
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 151
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 151
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 184
    F.4.2.2In the whole clinical trial 302
    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. Standard Routine Medical Care
    Zgodnie ze standardami opieki medycznej
    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 Decision2016-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-07
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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